In this episode, we discuss current evidence about post-surgical activity restrictions. Plus, we explore probiotics for GBS prevention, vaginal seeding, barbed sutures, disposable staples, and how to be faster during surgery.
Follow us on Instagram @thinkingaboutobgyn.
In this episode, we discuss current evidence about post-surgical activity restrictions. Plus, we explore probiotics for GBS prevention, vaginal seeding, barbed sutures, disposable staples, and how to be faster during surgery.
Follow us on Instagram @thinkingaboutobgyn.
This is Thinking About OBGYN with your hosts Antonia Roberts and Howard Herrell.
Howard:Antonia.
Antonia:Howard.
Howard:What are we thinking about on today's episode?
Antonia:Well, a lot of things, including fetal movement, probiotics, vaginal seeding, some of those fancy suture devices and how to be quick in surgery. But first, what's the thing we do for no reason?
Howard:Well, how about telling women that they can't lift or do physical activities of many different types after surgeries like hysterectomies or prolapse surgeries?
Antonia:Okay. So this is similar but different to what we talked about recently regarding pelvic rest after a birth. So now we're not even in this today's example. We're not talking about water or tampons or sexual activity causing a postoperative infection in the vagina or uterus. What we're talking about here, I think, is a restriction on activities due to the concern that maybe increased pressure inside the abdomen will push against those internal stitches and break them, or something like that.
Antonia:So traditionally, when patients undergo a hysterectomy, and especially with any pelvic floor repairs, then women are given sometimes pretty strict precautions on activity and lifting afterwards. I've heard things like don't lift more than five or 10 pounds or a gallon of milk, or don't do anything strenuous for six weeks or eight weeks or even 12 weeks, which is three months. I've also heard of women being told to never do heavy lifting again after their repairs for fear that this will break them down, although that's not necessarily been by any of my current or prior colleagues to my knowledge, but I've heard of it on the internet and stuff. But I'm guessing you probably don't tell your patients these super restrictive limitations. So what's the evidence on this one?
Howard:Well, I love things like this because it's an example of where things get so deeply integrated into the culture of medicine and what we do without any scientific basis whatsoever, just narrative fallacies, really. So if a woman has a hysterectomy, the hospital or surgery center undoubtedly prints off postoperative care instructions that say things like don't lift more than X amount of pounds often 10 pounds. This also happens for obstetrics patients, like we talked about before, for many different precautions, but lifting things too think C-section and lifting precautions and it happens in general surgery patients. It's in every book that you read about it or website all these precautions, but these activity restrictions just have no scientific basis whatsoever.
Antonia:So you told me before about a study that measured the intraderminal pressures generated with everyday activities, and it was surprising how much force is generated with things like standing up from a chair or coughing, and comparing that to how much force is generated by the things that we're telling people to avoid, like lifting 20 pounds, for example.
Howard:Yeah, there was a study published in 2014 called intraderminal pressure with pelvic floor dysfunction Do postoperative restrictions make sense? They measure the intraderminal pressures generated in women during some of the activities you listed. So these were patients who had pelvic organ prolapse or urinary incontinence who had resented for uroodynamics studies. So while they had the intraderminal pressure catheter in place, these usually go in the vagina or sometimes in the rectum. They were asked to stand up, to cough, to lift 10 pounds, to lift 20 pounds, also to push 20 pounds, and what they found was that just standing up generated 36.8 centimeters of water pressure on the reading, whereas lifting 20 pounds generated 19 centimeters of water. So having a 10 or 20 pound weight restriction makes no sense, unless you're also going to tell people not to stand up at all. But coughing generated 80.4 centimeters of water and it's not like we tell people if they're coughing after surgery, they need to make an emergency appointment or come in immediately to get cough medicine to make sure their stitches are not rupturing or something. So we assume all the time that pelvic organ prolapse is caused by the stress of heavy lifting and other strenuous activities, but that's not necessarily true. The data is actually very inconsistent.
Howard:I'll put a link to another narrative review about physical activity from 2020. And the truth is that engaging your core muscles and doing exercises that strengthen your pelvic floor muscles may be beneficial overall to having good pelvic floor support. And there are lots of narratives like this. We used to think that stomach ulcers were due to stress at work. That it's deeply ingrained in our culture, and there's some of the same sort of narratives that we have in obstetrics, where women are these vulnerable creatures who have to be protected immensely while they're pregnant and can't have any psychic or physical stresses. And none of those things are true.
Antonia:Yeah, there's also a study from JAMA surgery that randomized patients to standard restrictions versus expedited activity after pelvic organ prolapse surgery. This one was from May 31st of 2023. In this one they included 107 women who had either vaginal or laparoscopic reconstructive surgery for prolapse, and they were randomized to either the traditional restrictions, which in this study they specified as no heavy lifting more than 10 pounds for six weeks, return to work after two weeks for sedentary work like desk work, and after six weeks for manual labor or at least things, I assume, where you stand up all day. But for the expedited group, they were basically told to do whatever they feel like as soon as they feel like doing it, and in the results they found no difference in anatomic or symptomatic outcomes. And the post-op exams were done by providers who were masked as to which advice or which group the patients were in. And the patients also completed validated questionnaires about their subjective symptoms. And, yeah, the conclusion was that expedited recovery without activity restrictions was not inferior to the traditional restrictions.
Howard:I think sometimes in medicine and life in general, when things go wrong, we tend to want to blame someone else, and one of the things we do in OBGYN and in medicine is we blame the patient for when things go wrong. The truth is, these surgeries fail. Some women need second surgeries or even third surgeries due to recurrent prolapse. But telling them that it was their fault because they did too much activity or they were constipated once or something like that, doesn't benefit anyone. And that study, by the way, is not the first study to look at this. I'll put a link to a paper from 2021, from a one-year follow-up of the recoup trial in which women were randomized to either no limitations on physical activity or to restrictions on heavy lifting and high-impact activities for three months after surgery. And the original trial found, if anything, that the liberal group the ones that were allowed to do what they wanted to did better in the initial weeks after surgery and then at the one-year follow-up those patients again. They found no significant differences in anatomic or functional outcomes.
Antonia:All right. So the bottom line is we should not be restricting people's activities after a hysterectomy and probably most other pelvic or vaginal surgeries either, except perhaps for penetrative sex or use of sex toys or probably tampons as well. They shouldn't need tampons after a hysterectomy anyway, but these studies were on patients who had minimally invasive surgeries, so do you think this would change if they had a big abdominal incision either after a caesarean section or even a midline vertical?
Howard:Well, there just aren't studies, or at least good studies, which still means that these restrictions that we're giving, even for those patients with laparotomies, are not evidence-based and perhaps might be doing more harm than good. Activity restriction after caesarean increases the risk of DVT, impulmonary embolism, as well as the deconditioning that the patient experiences muscle loss, things like that and some of these restrictions women are given prevent them from taking care of their children or taking care of their pets or doing things that they need to do just to get by day to day.
Antonia:Yeah, of course, if a normal person that's not a professional athlete tries to lift something heavy enough without the proper training and technique, of course they can pull or strain something or even maybe give themselves a hernia if they're really aggressive. So obviously you wouldn't want a post-op patient to suddenly try lifting 100 pounds more than what they typically do, if for some reason they even wanted to do that. But if you tell someone not to lift more than 10 pounds for the first six weeks after a caesarean delivery, that practically means they can't even lift their own baby in a carrier or a baby plus their diaper bag or things like that, let alone if they also have an older child like a toddler to take care of.
Howard:Yeah, we're just talking about normal daily activities, of daily life, I think but we can extrapolate some of this from other studies that perhaps the intraabdominal pressures associated with coughing would be a reasonable upper limit to any voluntary activities like lifting. Now I don't know how much weight it would take to generate 80 centimeters of water Remember that's how much was generated with coughing but it would be a lot more than 20 pounds. So there is a trial that's underway that's trying to answer this question in a more definitive manner, and this is in patients with who have hernia risks and they're looking to see who has higher risk of recurrence and things like that, depending on what sort of restrictions that they're given. So hopefully we'll see this answer in a more definitive way in the next couple of years.
Antonia:Yeah, these restrictions are important because they're important to drill down on what's valid and what's not valid, because sedentary convalescence not only might increase your risk of DVT or even just muscle atrophy, or even because the negative economic impacts of not being able to work for more time than it's necessary, or even having to pull a spouse or friend or someone out of work to help, but also a lot of women may choose not to undergo pelvic floor repairs in the first place because they don't understand how they can continue their normal activities, their normal jobs, if they're supposed to restrict no more than 10 pounds for six weeks, or whatever those restrictions are, or the lifetime restrictions, like you mentioned.
Howard:I've definitely met patients who had put off having their incontinence fixed or something else, because another doctor had told them that they would just recur immediately if they just kept doing the same activities, especially think about people in the agricultural industry or things like that, where their job is just lifting stuff a lot and so they just live with the prolapse.
Howard:So the only real restriction that I give to women is related to penetration again intercourse or a toy or something like that, and I think that ideally this is until their stitches are healed up somewhere around four to six weeks. It's probably a little shorter than that, but there are different variables about how well people heal things like that.
Howard:So if you're doing four to six week restrictions on penetration, you're not going to have busted open vaginal cuffs, for example, but otherwise I tell them to do whatever they feel like doing when they feel like doing it. And most of our patients who have complicated pelvic floor surgeries, they go back to work in a week or two, sometimes as little as four days if they have sedentary jobs, desk jobs, things like that.
Antonia:That's yeah, that's pretty good, so let's move on. So we've talked before about fetal kick counts and maternal perception of fetal movement and how that relates to adverse outcomes like stillbirth. There's a study coming out later this year from Italy that looked at women's perceptions of fetal movement, among some other indicators, and compared this with a group looking at adverse perinatal outcomes, including mortality or operative deliveries for fetal distress. Low five minute app guards. Nicu admits and probably there was. I think there were some other outcomes in there too but they found that there was no association between any of those adverse outcomes and any range of maternal answers about the strength or the frequency or the vigor of perceived fetal movements. They also found no relationship between the mother's perceptions of fetal hiccups or for contractions.
Howard:Yeah, and we've talked about this a little bit before they did find that the biggest associated factors for adverse perinatal outcomes were either fetal growth restriction or macrosomia, and then followed after that by neonatal male gender, maternal null parity, low educational status and maternal obesity.
Howard:So we've talked about obesity as a predictor of adverse perinatal outcomes and the desire obviously now of a lot of folks to do extra ananatal testing, even though there's not robust literature to support this. But again, this shows that having a child with male gender in this study was 50% more likely to be associated with an adverse perinatal outcome than being obese. But of course, no one's recommending that women who are pregnant with male fetuses undergo extra ananatal testing. But yes, the study does tend to confirm that maternal perceptions of fetal movement are just not nearly as important as it seems like almost everybody thinks they are and doesn't affect, and shouldn't affect, our clinical practice in the way that I think it does. They also found an increased association with adverse perinatal outcomes among women with poor sleep who rolled around a lot and women who snored, but again, both of these were less important than maternal null parity or the male gender of the fetus.
Antonia:So it almost seems like bringing someone in for decreased fetal movement is mainly just to tell, is the baby still alive? And not to see. Is there some kind of additional intervention that we could still do to benefit this living fetus with decreased movement?
Howard:Yeah, you think about in over time how many times have you brought someone in or evaluated somebody for that and basically you either find that everything's okay or that they have a fetal demise like not much in between Now. Obviously you are sometimes going to discover oligo hydramneos or something like that, but statistically, if you look at that in controlled studies, you're just finding it by chance.
Howard:If you just brought in 100 women and did ultrasounds, you'd find oligo hydramneos in a percentage of them, whether they complained of normal movement or decreased movement. So right, the question is does this lead to interventions that save fetal lives by having this awareness about it?
Antonia:Right? And it seems like the answer is no. And yeah, we did talk about this more in depth before about how a program of formal kick counting and strict precautions didn't improve the perinatal outcomes compared to just usual care, and it's also reassuring here that they didn't seem to find any association with increased fetal movements and bad outcomes, because I remember you had mentioned that in a prior episode that more fetal activity might even have a worse prognosis than decreased activity. I cannot remember the reference for this.
Howard:Well, that's what Google says. I have definitely keep Google it. And hiccups are supposed to be bad too. It's all over the internet.
Antonia:This looked at the full range decreased and increased and found no association with outcomes.
Antonia:But of course, if we did actually start telling people to be vigilant not just for decrease but also for excessive movement, come in if it's too little or too much, of course we'd have someone coming in every night to triage. We'd have like pretty much all of our patients coming in every night. And, anecdotally, I've definitely never heard of a case where a baby, a fetus, passed away and the mom said well, the baby was just especially as vigorous and active the day before. So I don't think that that's real. Whatever that was, and obviously now this study also proves that in general, though we probably haven't appreciated the full extent of the associations between sleep apnea and adverse pregnancy outcomes, some of the historic association of adverse outcomes of obesity might actually be correlated to sleep apnea rather than the obesity itself. So we shouldn't hesitate to order a sleep study for a pregnant woman with poor sleep and fatigue, especially if she has other risk factors like a history of snoring or if you do that stop-bang questionnaire.
Howard:And perhaps just women with BMI is over 50 or 60. We don't know, the exact number, but sleep apnea is something we definitely should surveil for.
Antonia:Yeah, okay. Well, we're jumping around on different topics. Let's talk about probiotics to reduce the incidence of group B strep in pregnancy. There's a lot of stuff about this on the internet. Probably a fair number of doulas, or at least lay midwives, are recommending it as a strategy to decrease the chance of having GBS. I've had a couple of patients so far ask me about using probiotics because they didn't really want to have antibiotics than labor.
Antonia:So there was a review published in Midwifery Journal in 2021 by midwife named Lisa Hansen, and she looked at 10 studies about reducing the chance of having a GBS positive result on a swab. They didn't specifically assess the rates of GBS bacteria, but some of these 10 studies didn't actually delineate that, so we're presuming swab. None of them specified bacteria. Anyway, this review claims that probiotic intervention appears to be a safe and effective primary prevention strategy for antenatal GBS colonization, and in fact, they said that it reduces the rates of GBS positivity by 44%. That's quite a lot. So what do you think about this? Do you think it would be fair to start suggesting this to your patients?
Howard:I love your rhetorical questions, but no, I would not. So again, this concept and this paper which I've been handed this paper this is a commonly cited, talked about paper in that community. This is a wonderful example of the perils of this type of literature and of integrating things into your practice, based upon weak evidence and knowing what is good scientific evidence versus what is not good scientific evidence. So, as you already know, this study was funded by the American Lifeline's company, who is the manufacturer of Flouragen 3, the probiotic used in the study and the one most commonly touted by midwives on the internet. So this company makes fairly extraordinary claims about the benefits of their product and, of course, they're interested in funding any sort of research that could tend to validate those claims.
Howard:Now, the authors also said that only one study of the 10 that they reviewed had a low risk of bias. A fair number of these studies were just actually in vitro studies, which have absolutely no relevance whatsoever to testing in human populations. Only three of the trials were actually randomized, controlled trials, and two of those three showed no benefit. So, essentially, out of those 10 studies, one trial done by Ho and colleagues in Taiwan in 2016, in which they had 99 patients claimed to show a statistically significant reduction in GBS colonization.
Howard:So again, that's just a commentary on the way systematic reviews and meta-analyses are done, where you think you're reading something about 10 different studies and in fact nine aren't even relevant or show no positive findings, but somehow we changed the whole outcomes of all the other studies by one small study. This happens all the time. Now, in this particular study by Ho, they looked at women who were already GBS positive and then they gave half of them probiotics and the other half of placebo, and then they retested them later. So 42% of the probiotic women were negative on second testing versus 18% of the control group that received a placebo. So that's 21 women versus nine in real life and based upon that difference alone, the review that you cited makes this wild claim that probiotics reduce the risk of GBS by 44%, or rather treats 42% of positive GBS results, if you will.
Antonia:Well, that one result is questionable, since the other randomized control trials found that it made no difference.
Howard:Yeah, that's right, and a reminder that you can find a study that says anything and that sometimes, especially small studies are just off by chance. But that's what biased researchers and funding from a company that's looking to make a bunch of money will get you. But, more importantly, this wasn't labeled as just a review article. The author called it a systematic review and a meta-analysis. But again, slapping those words into the title of article doesn't automatically make it a legitimate thing. But we've been trained to think that.
Howard:I think If you review low quality, crappy studies that are poorly designed, not even maybe relevant, and you're reviewing heterogeneous populations with low numbers of subjects, then your meta-analysis itself is not worth much. In fact it really shouldn't be done. It's a whole other thing that I've not written about or talked about much, but the number of so-called meta-analysis is exploding almost exponentially in the scientific literature because it's easy to do so people. They do a PubMed search and then they decide to pull 10 articles out and get a meta-analysis published in an open source journal for a publication credit. But these are usually very poor quality. But people who hear the word meta-analysis or systematic review can easily be taken for a ride when they see those words in the title Because, as med students, we've been taught that that's the highest level of evidence, which isn't quite true. The highest level of evidence is a meta-analysis of homogeneous randomized controlled trials. Most of them are not.
Antonia:Okay. So maybe she didn't even do this question justice with the poor review or poor meta-analysis that she did, but would you throw it all away just because you assume that the author and the company are biased that finance the study and if a patient really wants to take probiotics, no matter what you say, and they're basically harmless? Is this something to really get so critical on?
Howard:Well, I would say we don't know that they're harmless, in the absence of scientific evidence to put that. But yeah, I still would throw it away and be critical, because the nature of science involves replication in not one small study from Taiwan and we make millions of dollars selling probiotics. But in this case, I have something better for you than that answer.
Howard:Okay, all right, well, the same researcher that you mentioned, Lisa Hansen. She went on to do a clinical trial of her own using the Fluorogen 3 probiotic, and that paper was published in January of 2023. All right, I'm listening, yeah, so in this study, hansen and her colleagues randomized 109 women to either placebo or the probiotic, starting at 28 weeks until labor started, and then they collected a baseline GBS and then they retested it 36 weeks or so as per standard protocol, and they found no difference. They found it doesn't work.
Antonia:Well, I know you love negative studies, so we should think of this as good. It's more like a definitive answer, but I imagine that they didn't admit defeat that easily. Well, of course not.
Howard:So they claimed that the prevalence of group B strep was lower than expected in the study population.
Howard:And here it's to the intervention group was poor. But that's exactly what a person who's being paid by the company to do a research trial would say if you're trying to gild the lily on negative findings. We see this all the time in the industry. But adherence is adherence, and if people can't adhere to the intervention, then the intervention doesn't work. You can't blame the patient for your failed product, just like you can't blame the patient's activity for your failed urogynecologic surgery. And they found that around 20% of their patients tested positive for group B strep, and that's well within the typical positivity range that we see among Caucasian women in the United States, which is who their public paper was on. So they don't have much of an argument there either.
Antonia:For nutraceuticals and other products like this. A lot of the studies are very poorly controlled and poorly designed and paid for by the manufacturers, and often with less than 100 or even less than 50 patients, and they're often enrolled under circumstances that are most ideal to the manufacturer. So they're controlling for variables and reporting outcomes again ideal for the manufacturer and eventually, even if such a study shows a benefit to their product, robust studies that are done in a nonbiased way or a less biased way would show the error of those smaller studies. But the manufacturer will still selectively cite their own tiny study out of sometimes dozens of others that don't show benefit and keep using that crap study to help sell their product. And it also helps when they pay for systematic reviews and meta-analyses and twist out the outcome that they want out of it.
Howard:Well, it's also interesting that this trial was published in 2023, but the data was collected and finished in June of 2021, five months before the meta-analysis which she wrote, which claimed to benefit, was published. So she had the data from her own trial already at the time she published the meta-analysis.
Antonia:So you're saying that the author knew at the time of writing the meta-analysis that her own trial, which was larger than any of the ones in the meta-analysis, would show no benefit?
Howard:Yeah, and I'm suggesting that, after the trial showed no benefit, that a decision was made to proceed with the meta-analysis and delay publication for a couple of years, because this company is making a killing off the selling basically nothing to people.
Antonia:Seems like she was just, yeah, just in denial.
Howard:Well, maybe I don't know anybody's intentions, but I'm saying that this is not science and this sort of paper would be great for a general club review to go through and look at that meta-analysis, for example. If you want to understand why meta-analysis are like this or poor quality, this would be a great journal club article for your program.
Antonia:It's always fun to have an article to tear apart in journal club, mix it in with some good ones, but also tear something apart.
Antonia:Okay, so on a semi-related topic, what about vaginal seeding? And for just to explain, this is swabbing a baby who's born by caesarean with some of the maternal vaginal secretions, with the thought that somehow this is important for their immunity or microbiome, because they're missing out on this natural exposure that they would have gotten with a vaginal delivery. It has been a while since anyone asked me about this, but the last time someone did, they were not at all casual or neutral about it. They felt very strongly and seemed to be very insistent on the benefits of this practice, I think because of what they had read and they had all these citations. So I'm not sure if it's the norm for people to feel that strongly about this topic, but it certainly. Just this anecdote makes me think that there must be some strongly worded articles out there, but we already know that the whole weight of the research is poor quality, and it must be because ACOG specifically does not recommend this practice. But I'm curious do you have patients that do this, or?
Howard:request this? Well, of course I do.
Antonia:All right. Well, why don't we talk?
Howard:about science. Well, we could tell much the same story of lots of low quality trials, but there is a randomized control trial published in 2021 from New Zealand that was meant to be a pilot study to inform a larger trial, but they found no difference at all at one month or three months, specifically looking at the type and amount of microbiota of the infants, whether seeding had occurred or not. This was a small study, but other similar studies that have been observational have been published in the British Journal of Estetrics and Gynecology in 2020. There was a debate published about this topic and one of the authors on the pro side is a US patent holder for a method of performing microbiome seeding for newborns after cesarean delivery. She's very much a favor of it, of course. In fact, she had dozens of low quality publications and dozens of different low quality journals arguing that antibiotics at the time of cesarean are just the most dangerous thing ever to our health and that bacterial seeding is a panacea against almost every disease you can imagine.
Antonia:Is this person a doctor, like a board certified doctor? I hope not, but I get the theory. After all, there are fecal transplants that are done as an actual, evidence-based treatment for clostridium difficile, like the colitis, but theory that is contradicted by evidence then just becomes nothing. It's just an imaginary story. Also, how do you even patent a method for vaginal seeding? Because I think if there was any evidence to support this practice, then we could literally just take some gauze or a sterile glove or something like that and just use that for the swabbing. So a patented device just seems like something you don't need to just waste.
Howard:Well, everybody needs to make money, I suppose. And no, she's not a doctor. I don't know how she patented this, but she did. The diagram just shows taking vaginal fluid and putting it in the baby's mouth, then wiping its face off and then wiping its body off, and this patent doesn't expire until 2036, so we'll have a few more years of some company trying to sell this product to us at the next annual ACOG meeting.
Antonia:So currently the only randomized control data we have says it's ineffective. So knowing that it's completely useless and that unnecessary makes that visual just.
Howard:Rotator I don't know, Just yeah, yeah it doesn't do anything and honestly, the whole gut biome, microbiota stuff is for the most part, off the rails. That a lot of stuff you see on TikTok.
Antonia:Okay, so she's not a doctor, so why should any doctors listen to her Like what's her background? She's an ecologist.
Howard:But judging from her CV, she seems to have a bias against antibiotics in general, believes that they're ruining our world and she believes that, due to alterations in our gut microbiota, that we've created a plague of diseases, including type 1 diabetes, autism, allergies, asthma, obesity, celiac disease and a bunch more. She's very much against a lot of modern medicine and also doesn't seem to understand. The genetic etiology of most of the diseases I just listed has already been well-established, so she has a bias.
Antonia:It's only 27 pages and it's on the internet. I think you might need to get out a little bit more. Well, I get you know amused easily Rabbit holes. This seems more harmful to me, potentially, than probiotics does, because what if the mother? What if she has herpes or chlamydia? Usually we detect those things, but what if we didn't? We think we're rubbing some healthy flora on and then we're rubbing some pathogens on.
Howard:Yeah, caesarean definitely decreases the rate of vertical transmission of a lot of those things, Group B strep even , for that matter.
Howard:But I'll say that all of these sorts of things are harmful in another way, and I was reminded of this because this past week or so there was an article on MedPage about a nobigian in Wisconsin who surrendered her license after a patient died of advanced endometrial cancer. And I took a deep dive in her CV as well Not the first time her license had been suspended, but basically she was treating endometrial cancer with a bunch of things like thermograms and bio-dynical hormone therapy and just the list of all of the stuff that is quackery but appeals to a lot of people on Instagram and TikTok with wild claims. There's a bunch of stuff on there on her. If you Google her and I'll put a link to the story. But if you Google her, you'll see this is all the kind of stuff that she would feed into. So I think it does create an interesting ethical situation for us, because when a patient comes and asks you about probiotics or asks you about vaginal seeding or something like this, it's completely non-scientific and is just being pushed by companies looking to exploit pregnant women.
Howard:If we're being completely honest, well, what we should do is say I don't recommend that, and here's the scientific evidence. Now, it's a free country. People can do what they want to do, but what some doctors do is say oh well, that sounds interesting. If you want to do that, that's great, I don't see any harm in it. And that's just not the case. We have to take a hard line, because it's a slippery slope where something that seems innocuous may not be. And so vaginal seeding, for example, if it did transmit herpes to a newborn or GBS, that led to sepsis or meningitis and it kills two babies a year because this becomes a commonplace thing when it have offered no benefit, then we've harmed people. So our job as science-based physicians is to tell people the truth about things. Now, people have choice and they have autonomy to do what they want to do, but our job is not to cater or pander to people or exploit them with misinformation.
Antonia:Yeah, I'll have to look at that story. That definitely sounds sketchy, but I can imagine like what if the patient refused an oncology referral and then she said I only want it Could be all kinds of details to it, but still our job is to offer the right treatment period. Yeah, exactly, okay, well, jumping around again. I've been wondering something else. Have you tried the Stratophix PDS suture to close fascia at the time of cesarean, or?
Howard:I think that's at least the fourth question you've asked me that you already know the answer to, so do you think I have tried it.
Antonia:No, but I assume you've heard of it.
Howard:I have seen it then, but I have not used it.
Antonia:Well, why don't we talk about this for a minute? So it's a barbed suture with a built-in stopper at the end. It's just like a little rectangle, or maybe sometimes a triangle, of suture material, and that stopper is supposed to eliminate the need for tying a knot, and I guess the barbs are supposed to eliminate the need for holding tension every time you're throwing as you go along the length of the incision, and it's being marketed as a way to close the fascia. So, of course, this idea of suture is already in practice and commonly used with finer material to close the vaginal cuff during a laparoscopic hysterectomy, or perhaps to close the uterine incision at the time of a laparoscopic myomectomy, for example, and I've even seen really thin versions of barbed suture being used for skin closures as well. Well, okay.
Howard:I get that. Pds knots can be bulky when you're doing eight throws to tie it down, especially when it's in a thin patient and there's not much on adipose layer between the fascia and the skin. But you can tack the knot down against the fascia so that it lays flat, so that's not much of an excuse. My theory is that this is for people who don't tie knots well, which shouldn't be any surgeon frankly that you want operating on you.
Howard:But I did look at a few articles about these sutures and the selling points related to them, and all the articles seem to be authored by people who own stock in the manufacturing company. I think that's the theme for this episode and I wonder if that's related to their findings?
Howard:and how much do these sutures cost, by the way? Like, let's say that I normally use a looped PDS at the time of cesarean and I have to tie that one knot at the end. Oh my gosh. But now I don't have to tie any knots if I can just use the stratifics. What kind of money are we talking about here? Because that's going to save me about five and a half seconds.
Antonia:Well, the prices vary by contracting with facilities, but in general the looped PDS costs about 25 bucks and the stratifics costs about 80 bucks per surgeon.
Howard:Okay, well, we can add this, I think, to the list of things that don't contribute to value-based care and obstetrics that we did earlier. Now, if your hospital does 500 cesareans a year, the difference in those prices adds up to about $30,000 just on extra suture, and again that's not reimbursed. That's money that adds to the total cost of health care and it's money in your hospital that's not being spent on more important things like nursing salaries or scrub tech salaries or things that actually make a difference for your patients.
Antonia:Yeah, I think these things are marketed to hospitals and physicians as something that maybe could decrease the risk of wound complications, and so if you could prevent even one significant wound complication out of those 500 cases you do per year, then you might end up saving money overall, because it can be very difficult and very expensive to treat those complications, and that's actually true, and that is how it's marketed.
Howard:The what ifs. If you had this one rare case, and how much that would cost. The problem is there's no evidence that it does anything beneficial in terms of reducing those complications. So again, here we have theory, and without any evidence, and a house of cards predicated upon theory. This sort of marking reminds me of the negative pressure wound dressings like the Provena that we discussed earlier, or the Insorb device, which is this little absorbable stapler for closing skins at the time of cesarean. There's just no quality evidence that Provena or Insorb or any of these things make any difference in outcomes for your patients.
Antonia:Yeah, I haven't seen the Insorb used, but people I know have seen it at like, maybe at some of their rotations during training, and they definitely were not impressed. But yeah, this stapler is marketed as being better than metal staples in terms of pain and complications. But when they talk about comparing it to traditional suture, their selling point there is that it eliminates the risk of needle stick injuries to the surgeon and, of course, that there are no knots that could come undone.
Howard:Right.
Howard:So just come up with a theory and develop a sales pitch like who needs data?
Howard:Well, the funny part about that is that you don't even need the knot after you put the derma bond on, so you really only need the skin suture to hold long enough for you to get the derma bond on, which is a minute or less, and you could actually remove the suture. I know people who do that. You take the suture out after you've put the glue on, so the knots coming undone or something like that isn't a concern. And you know what sort of surgeon buys a product because they lack so much confidence in their knots during a subcutitcate or closure where there's virtually no stress on the incision line itself, that they need something to replace their knots with. And the concern about stabbing yourself with a needle or something like that come on, but again, there's no meaningful clinical data that using this is better than what we recommend to do. They're making the wrong comparison not to still staples, but to subcutaneous suture or closure with glue applied as addressing. But how much does this cost the stapler?
Antonia:It was $45 in 2008 when it first came out, so at least it's cheaper than the stratifics for fascia. I found that in a review article from that year where a physician reviewed the pros and cons of this insorb device and said something that I know you're going to love. He was commenting on the company justifying the increased cost, because obviously this does cost more than a subcuticular suture, and they were saying there's decreased operative time. There's no need to have the patient come back a week later to have metal staples removed or to have to do it on rounds if they're in the hospital that long and he's. And this physician said quote even from a truly lazy rounding doctor as the reviewer who hates removing metal staples, this seems to be a stretch. So that was Dr James Greenberg, who at the time was a Harvard.
Howard:See a bromance starting, let me interact with him. I too am a lazy rounding doctor, but what's the current cost of this thing? That was 2008.
Antonia:Yeah, I think it's gone up to about $60 now, depending on contracting, so definitely still a lot more expensive than the suture.
Howard:So that's a hard pass again for me, and there's another $30,000 if you do 500 cesareans a year. Again, we're talking about not having nurses working for your hospital because you're wasting money on stuff like this. So we'll have to add both of these to our list of things that don't contribute to value based care and obstetrics that we did a few episodes ago. And all this reminds me of something I call the golf driver paradox.
Antonia:Okay, I don't play golf, but go ahead.
Howard:Well, I don't mean to mix metaphors, but there's an old baseball adage. I should have just used the baseball adage that says that a $300 bat won't fix your 50 cent swing, but for a lot of physicians they play golf. I would say that an $1100 Callaway golf driver won't fix your 10 cent swing. The principle is the same. Use whatever analogy you like, but a lot of institutions are interested in fixing problems like wound infection rates or the length of surgery at the time of hysterectomy or cesarean or anything else. So they invest in more expensive bats and golf clubs with the promise that this will help them to some degree fix some of these things that they're dealing with.
Howard:But the fundamental problem is not their lack of new and fancy technology. What they need to focus on are really just the very basics. If you're operating room times run long, it's likely that you have some basic skills that you need to work on. Great surgeons don't need fancy add-ons and special devices and all these other products that have been invented, really looking for a problem to solve by a company who's looking to make money. If you're seeing lots of wound infections, it's likely that your basic technique, along with your length of surgery, leaves something to be desired. So you've got to get the basics right first.
Antonia:Yeah, and that probably includes things like making sure the sterilization system is working as it should be and that the room's being cleaned as it should be and the patient's being prepped as they should be too.
Howard:You're waiting for the prep to dry and lots of things there in there.
Antonia:Yeah, we could talk again sometime about speed in surgery and specific things to do or practice to become better at these basic things. That also would that we can directly control in ourselves to decrease excessive operative times. So baseball and golf and every other sport that involves any skill have drills and practices that you can do to become better and better continually at those basics. The longer you play as a pro, the more the better you're assumed to be and expected to be. But I don't think we emphasize that sort of physical drilling in surgery, even though it is a very physical thing in addition to being a very cognitive thing as well. So as a result, you see huge variation in operative times for every procedure, but especially things we do all the time like says.
Howard:I think that variation is the key. If there was limited variation but you had a new product that could take the median down 15 minutes in the OR, that might be worth $500, given how much OR time costs things like that.
Howard:But right now we're in a world with huge variations in times and outcomes. I'll put a link to a review from a few years ago that looked at factors specifically influencing cesarean operative times and, most interestingly, they found a range of time from 13 minutes to 108 minutes, but the average time was 44 minutes. They looked at all sorts of factors that might contribute to longer surgery but interestingly to me, one of the things that did not contribute was the patient body mass index. Again, blame the patient, right, that didn't factor Things that did contribute. They make sense things like the number of previous cesareans a patient had, so obviously that correlates to how much dense scar tissue you're cutting through things like that.
Howard:And the addition of other procedures like a tubal ligation. Obviously it takes a little bit longer. They also found that residents were faster than the attendings by about seven minutes in which where they were both groups, and I think that's interesting again for a few different reasons. First is how wide of a variation in time there was. We all know, it's true, some people take an hour and a half, some people take 13 minutes. I don't know why it took 13 minutes, but that's okay. But also the things that people again blame it on, like the patient was too heavy or I was had residents. They're not actually true. The residents are fast if you let them be, and the patients BMI shouldn't affect how long the surgery takes. So I definitely think that we could talk about ways to be speedier in surgery.
Antonia:This finding, is very interesting to me, so I looked at this. This was published out of UNC, in Chapel Hill, I think, in 2010. They didn't specify or distinguish between levels of resident, and I always have felt that chief residents, like fourth year residents, are at least as good, if not better than, their attendings at whatever procedure they've just been pounding away at nonstop during their training, especially if they're currently on the end of a block and they've just been doing like five of these a day, every day. That's definitely more than their own attendings at that same place I've been doing yeah.
Antonia:So this effect maybe potentially could be getting diluted a little bit now compared to 2010. Since now we have work hour restrictions, but even so, a chief resident on an obstetrics rotation definitely does more caesareans every week than any of their attendings do. But I also would have a hard time believing that a beginner resident is still faster than their attending. So I would like to know in this study how that broke down and they didn't specify. But sometimes, especially earlier, trainees can be very tentative with a lot of steps. For example, they might need to take multiple swipes with the scalpel to make an incision that could have been made just with one smooth motion. Or maybe they don't know how hard to push on the mother's uterus to get the baby's head to come out of the historotomy.
Antonia:Or another thing I've seen a lot is that they're just so perfectionist, in particular with their suture placement, that if they place it just a half millimeter off from what they wanted, they'll back out and try again the whole way through and no amount of cheerleading to go faster. You're doing great, just keep going. You don't need to redo. Every single suture can necessarily get through. Some people are just so perfectionist and eventually most people grow out of that phase during their training and some of those things also could be partially attributable to the attending for, maybe not teaching, those things better. But what would you say are the key takeaways of the speed principles, because I know you're definitely on the faster end of that spectrum with your surgical time some things you just described your attitudes at your residence might have, and I do find it's difficult to teach attitudes.
Howard:You can Show people your attitude, but it's difficult, especially if you have limited interaction. You're not the only person. Interacting with a learner is difficult to really transform Certain attitudes. We can talk about that later too. But speed in surgery is, I think, bold down to what I call essentialism do the necessary steps of the procedure and do no more. So people waste a lot of time doing unnecessary dissections In c-section, for example, of the rectus muscles off the fascia, are using the bovie for every little splash of red they can find anywhere. Or closing the parent name of the rectus muscles or other things that are not part of evidence basis serian technique, which we've talked about a couple of times here before.
Howard:So so one thing is stop making the surgery longer by adding unnecessary steps that don't benefit the patient. In fact may even harm the patient. Another easy step to do is just anticipation.
Howard:If you think about how many times you ask a scrub tech for an instrument or suture or something that you need during surgery, well, if you ask for it once you're already waiting on it, once you're already at that point, then a significant amount of time will be added to your case. This is especially true if you're frequently working with new or rotating scrub techs who themselves aren't anticipating well what you're going to need next. If you can ask for something before you need it, in anticipation of needing it, you literally will shave many minutes off of your procedure just from doing that. So I sometimes wonder that my scrub tech is frustrated with me because I asked for it and she may already have it, of course, but she's sitting there waiting on it. But they're not. It's ready as soon as I handed the other thing. It goes right in my hand, and little things like that make a big difference.
Antonia:Okay, so essentialism and anticipation is that it or no?
Howard:well so in my vaginal strength, but there's an appendix about speed and surgery and I talk a lot about the steps of essentialism or what that means and how to make procedures as simple as possible. So that requires a lot of learning and thinking about each step and a lot of applying Learning the science that we have to what we do in the operating room, which I think has been an area where we've not done as well. It's hard to study surgical procedures, for example. It's hard to come to firm conclusions. But another big one and this is Attitudinal again, it's just confidence, and confidence comes through learning as much as possible about what you do and having a large repertoire of techniques to draw from if you get into trouble or something's not quite the same, as well as just learning the anatomy very well and understanding not just how you do things but why you do them. I think we spend way too much time just copying people and not understanding why we do the steps. When we learn, you really know what the surgery as a whole Is and how to do it, but what every step is you know very well and suggest memorizing and parroting what people have taught you. Then you can start to work on efficiency and you can really improve your efficiency by filming yourself or assisting others and looking at where they're inefficient and learning how to improve to.
Howard:But you also need to see good surgery performed and I think a lot of residents honestly haven't seen surgeries done well. They go to a residency program where the attendings operate that much. They're always watching learners operate and they don't see like surgery done really well. They don't see 10 minutes he sections or 15 minutes to rectumies. Teaching surgery can be a tough balance of allowing people the hands on experience that they need to learn, but also with the appropriate amount of showing first. And in a world where we're so worried about getting numbers, we don't show that often if a resident reads about a surgery, then you're watching them do it. They're still very clearly different. They're uncertain about what they're doing. It might not be enough to try to talk them through those steps. You might need to take the tools back out of their hands and show them the way to do it right, but still doing that in an empowering way so that they can actually learn the technique and confidence and do it better the next time. It's a difficult and challenging thing but there is frankly a lot of blind leading the blind and academic.
Howard:Go to you and I also believe personally in mental visualization of procedures. Go through each step in your mind, be able to picture it and think about the way the sutures laid down, think about the way the instruments handed to you, how it's turned, where the anatomy is, where your assistance are. If you can visualize, with your eyes closed, an entire procedure, you can probably do it really well, and also that rehearsal will help you. And then debriefing at the end of surgeries with your team, with your learners, with your scrub tech, with whoever what went well, what didn't go well, what can you work on for the next time. Things like that. That needs to occur with some frequency, particularly in Learning institutions. It should happen every time and make sure that you're using the best tool available and not making your job harder. That's just knowing your surgical instruments well, knowing what types of clamps and Retractors and pickups and different things are available. That doesn't mean go by a robot. That means know your kit well and use the right instrument for the right job.
Antonia:So have the best tools, but you're not saying yeah get the three hundred dollar baseball bat or that Strati fix or that.
Howard:I actually say in that, that part of the book, that you should get the basics right before you venture off into any technology. And when you do, you'll find for the most part that those things are unnecessary. There are circumstances where we're gonna talk about this sometime but we're like the notes could be very useful, even to a very advanced vaginal surgeon, but it's not a replacement for just basic vaginal surgery, right? So these tools sometimes do have a purpose. As anti robot as I am, there are things that I would use a robot for, but they're few and far in between and we've got to work and get the basics right first.
Howard:Another thing that, speaking of vaginal hysterectomy that I've always loved from vaginal hysterectomy is almost in a poetic manner, is that error begets error. When you first make the circumferential serve cervical incision, if you make it in exactly the right place anteriorly and posteriorly, the case will be easy. If you make it just a little bit too distal or a little bit too proximal, you will struggle. You'll struggle to make your posterior colpotomy it'll dissect down in the wrong way. You'll struggle to make the anterior colpotomy you'll be too deep. So error begets error.
Howard:Getting the small things right, getting the anatomy right. Getting those steps right makes things so much easier. You've got to really master the small stuff and get them right every time and then the big things take care of themselves, because big things are just a series of small things. And recognizing what those small things are and practicing them and working on them and you get better and better. And maybe the most important part for speed in the or for most things just having a high quality team of people that you work with frequently, that know what you're doing, what your expectations are, how they can be helpful and that you communicate well with.
Antonia:Yeah, well, definitely a lot of good follow up topics for later. I think residents and even Attendings can often be overwhelmed with all of the different ways that different people, like different colleagues of theirs and then those different teams that they work with, do different surgeries, especially when they're still learning and growing in their confidence and they don't know exactly which parts are essential and which parts aren't. And those parts always seem to be done differently and they don't know what can you, can you skip completely, and what do you absolutely have to do. But at least for cesarean, we've talked about the essential steps in different episodes and I think you were working on a nice, don't diminish your goals.
Antonia:Yeah, yeah, a collaborative guide for the essential steps of that and other things too, and consideration for a lot of common surgical procedures so that folks, especially folks who are involved in any way and are trying to study and learn more about it, can look forward to accessing this guy.
Howard:Yeah, we'll see how much progress we can make in the next six months or so. But that is for a lot of learners this time of year July of intern year or whatever for a lot of new residents. They're all struggling with exactly what you said. Which steps should I be doing? How come this doctor does that and this one doesn't? And it gets confusing and they don't really know. And they don't know how to access the literature. Well, enough to answer some of those questions.
Antonia:So we'll work on that project we will well, we'll wrap up today, so the thinking about the website will have links to things we talked about, and we'll be back again in a couple weeks.
Introduction:something else Thanks for listening. Find us online at thinking about OBGYN dot com. Be sure to subscribe. Look for new episodes every two weeks.