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A couple of interesting new articles in General Surgery News
One of them requires signing up. It is a discussion about topics in hernia repair, done, apparently, by written questionnaire to several well-known surgeons. Dr. Voeller is one. He seems to be getting “radicalized”, his comments run parallel to the current political climate. Very emphatic. Kind of fascinating to see how it permeates medicine too.
The other is one that is interesting from a scientific perspective. Studies were done that did not produce expected results. So weaknesses were found in the studies. It is a common problem, cognitive bias. Starting with a hope or goal disguised as a hypothesis.
Signing up is easy and you will get emails when new issues are published.
“MARCH 31, 2023
On the Spot: The Art of Herniology: Current Debates
“Should general surgery trainees be required to train on the robotic platform and achieve robotic certification in order to graduate?
Should more be done proactively from those collecting data in surgery to protect surgeons from the potential unintended consequences related to surgeon liability?
Does robotic eTEP potentially put hernia patients at risk for undergoing unnecessary roboTAR due to the inability to reliably close the posterior rectus sheath?
Should performance of complex abdominal wall reconstruction techniques be limited to surgeons who have had formal subspecialty training?
Is hernia a chronic disease?
Does industry meet a high standard in vetting its educational material?
As hernia reimbursement undergoes vast changes at a federal level, should professional societies get involved in advocacy and education?
Read on to see what some of the experts think!
…”This one should be viewable –
“MARCH 22, 2023
‘Embedded’ Trials Address Pressing Clinical Issues in Hernia Repair
One excerpt –
“The Open Versus Robotic Retromuscular Hernia Repair RCT
Standing in for his colleague Jeremy Warren, MD, M. Wes Love, MD, a minimally invasive surgeon with Prisma Health, in Greenville, S.C., discussed the results of the long-anticipated ORREO (Open Versus Robotic Retromuscular Hernia Repair) trial, which attempted to establish whether minimally invasive abdominal wall reconstruction results in clinical outcomes that are superior to open repair.
Other than reduced length of stay, they found no significant advantages. While patients undergoing a robotic repair had an average hospital stay one day shorter than those who had an open repair, there was no statistically significant difference in the primary composite end point of surgical site infection, surgical site occurrence (ssO), an ssO requiring procedural intervention, readmission or recurrence.
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The researchers are waiting to collect patient-reported outcomes and the two-year recurrence rate to cap off the study, “but we kind of know where this is heading. It was underpowered, and recruitment was surprisingly difficult,” Dr. Love said, noting that a surprising number of patients were strongly averse to a robotic repair.Ultimately, what was originally planned to be an overpowered analysis that would require two years for enrollment and yield plenty of data to demonstrate significance turned into an underpowered analysis that took four years of recruitment due to patient reluctance. …”
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This discussion was modified 1 year, 8 months ago by
Good intentions.
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This discussion was modified 1 year, 8 months ago by
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1 Reply
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“Studies were done that did not produce expected results. So weaknesses were found in the studies. It is a common problem, cognitive bias. Starting with a hope or goal disguised as a hypothesis.”
While this no doubt occurs, I think it is very important to understand the methodological components and contexts of the studies being discussed before implying that is the case here. Just because a study did not go as expected, I don’t think it is fair to say that weaknesses were then ‘found’ in them. Sure, cognitive bias exists…but it is not inherently inappropriate for a hypothesis to represent a ‘hope’ of the researcher (of course it often does – otherwise, why did they develop the hypothesis that they did? Why are they doing the study). The real concern is the BASIS for their hope…
I kind of agree that the excerpt study seems flawed. I don’t see a problem with their comments on it ending up underpowered (appreciating how power, effect size, and sample size are related). The the intent-to-treat vs. per protocol analyses debate is nuanced and complex, with both having pros/cons that vary across contexts. I think that I can appreciate how several of the very good reasons why ITT is so often preferred in clinical RCTs may not be so applicable here, and how PP may be preferable for the purpose in evaluating the two interventions. It’s a long discussion though and it would be helpful to see their full study, with follow-up data, to really get into the weeds.
The comments on the RINSE trial and the fixation in VHL study don’t seem problematic to me…?
The last one though…I’m not knowledgeable about the two techniques…but he characterizes the differences of opinion on both as ‘philosophical’ and maintains that the pros/cons of each technique just need to be weighed against each other, with pain coming with the territory on this type of repair…yet he also says “but the idea that intraperitoneal mesh is bad is hard to prove in the context of a RCT, since those events are rare and often occur many years later”.
Ok…but if you are advocating for weighing the pros/cons each, we need to weigh ALL of the pros/cons, not just those that are short-term and convenient to evaluate, or because some of those cons might be ‘rare’. This would seem particularly important if one technique may be more likely to have those long-term (albeit rare) problems. It’s reminiscent of the ’tissue vs. mesh’ repair debates where older studies didn’t have long enough follow-up periods despite assertions that mesh problems can present beyond those timeframes, and more so than tissue-repair problems. Yes, it is hard to do long-term follow-up…time-consuming, expensive, much subject attrition…but that data is potentially very valuable.
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