MarkT
Forum Replies Created
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Keep in mind an abstract provides only a small amount of *some* key information that is essentially meant to allow a reader to determine if an article is likely to be relevant for their interests/purposes (i.e., if they should read the whole study).
It is quite inappropriate to make assumptions about (never mind critique), a study from the contents of its abstract.
I pulled a copy of the article and will try write up a more coherent summary later, but some points:
The authors are rather clear what ‘open’ means when you actually read the article instead of making assumptions:
“Open inguinal hernia repair includes any technique of primary open inguinal hernia repair excluding Shouldice and mesh repair, performed in patients above the age of 16 years.” For the purposes of this study, they categorized the primary surgeries as: Shouldice, open mesh, open tissue, laparoscopic, and childhood (all types).
Keep in mind this is a retrospective study…data was pulled from existing medical records) rather than a prospective study where they could have chosen exactly what data to collect over its course (and this might explain why lap repairs were not broken down further?)
As an aside, they provide some insight into how Shouldice Hospital allocates recurrence cases:
“As this is a group-based practice, more complex cases are directed to surgeons according to their experience. In this categorical system, recurrent hernias are recognized as more complex than primary hernias. Among the recurrent inguinal hernias, previous primary hernia operations in childhood or via laparoscopy are considered low complexity, open (non-Shouldice) tissue repair is medium complexity, and open mesh repair or Shouldice repair is classified as high complexity.
When facing difficult cases, sometimes intra-operative consultations were required. In this situation, a surgeon may request another of equal or higher seniority to come to the operating room to discuss options. The consultant surgeon may assist by providing directions/opinions, scrub in to assist or take over the role as main surgeon to finish the case, according to the circumstances. Senior surgeons have many years of experience in hernia repair and at least 1000 cases of inguinal hernia repair at this institution”.
Among their findings was that “…open recurrent surgeries for previous open mesh and Shouldice repair were associated with higher intra-operative difficulties but not with worse early outcomes.” They hypothesize that this may be partly due to the way they allocate cases to more senior surgeons, and they conclude that “This information may allow adequate allocation of surgeon experience and choice of method (laparoscopic or open) based on the initial surgery”.
Higher proportion of direct hernias in recurrent group vs. primary group…i.e. more likely to see direct hernias recur, which is in line with other research, and this was true for all groups regardless of previous primary repair type.
Higher number of indirect recurrences were found only in group who had prev lap repair, which is also in line with prev research. “This may be due to case difficulty, technical errors during surgery (including missing small indirects or lipomas) and learning curve exploring the inguinal canal by laparoscopy…The higher incidence of direct recurrences for most of the
patients is likely related with the primary characteristics of connective tissue from hernia patient”.In the discussion, they remind us that Shouldice is a high-volume specialized center..surgeons performing ~600 repairs per year, 85% of which are inguinal…while most repairs around the worlds are NOT performed in such a context, and that recurrence has been reported to be linked with volume (i.e. higher rates among low-volume surgeons). Given this, “…we agree with the general idea of laparoscopic surgery following open hernia repair recurrences (tissue or mesh repair)…The laparoscopic surgeon will find virgin territory and be able to perform a relatively easy operation. The degree of difficulty found by our senior surgeons in reoperations after Shouldice repair or open mesh repairs has triggered an internal reflection and will lead to further discussion about the surgical management of these cases”.
There is prob still more to discuss…I’ll try to write more later.
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Shouldice has been around for 70 years…try again.
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There is no way to answer that question from this study, unfortunately…I would suspect there is tremendous variation between cases.
The 460 cases came from hernia specialists at St. Michael’s Hospital in Toronto, Shouldice Hospital, and other clinics in the U.S., Canada, Germany, and Romania.
The reasons for removal among the 460 total cases: pain (360), recurrence (85), infection (43), erosion into organs (13), and bowel obstruction (4).
Looking at only the 333 groin hernias: pain (300), recurrence (50), infection (3), erosion in organs (0), bowel obstruction (0).
(The sum of the reasons exceeds the total because some cases had more than one reason).
Because plugs are “known to behave differently”, they did look at that subset of cases: “All 40 cases of excised plugs were from the groin. Out of these, 39 were removed for pain and 1 for recurrence. The time lapse for plugs was longer than for flat meshes but it was not statistically significant (4.88 vs. 3.75 years respectively for 50th and 16.01 vs. 14.65 for 95th percentiles, groin hernias). Almost all (98%) plugs were removed for pain in comparison with 89% of flat meshes in the groin. This difference was borderline significant (p = 0.053).”
From the discussion:
“The 50th case percentile in our dataset was reached at 3.75 years after mesh implantation. This indicated that studies of comparable median follow-up time may have a large, up to 50% underestimation of the complication risks.”
“Our 15-year time lapse at 95th percentile may still be a conservative estimate at this point, as younger patients who underwent implantations in the 1990’s will live for several more decades.
Based on our PubMed search, the overwhelming majority of the published studies had follow-up times of less than half of this time. This indicates that there is a large degree of underestimation which is not readily acknowledged in the literature and subsequently not recognized in practice”
There is a fair bit more to the study in terms of discussing methodology and data collection, their results and other research regarding each of the complication types, and standardization of reporting (which, while lacking, can’t replace longer follow-up time that is still necessary).
Of course the specific details are interesting and important, though the broader conclusion is unfortunately not terribly surprising…we have don’t have very good data due to insufficient follow-up time.
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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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He defined it as post-op pain that persists after three months.
Because it is a retrospective study, it is looking back on data that had already been collected (vs. a prospective study that purposefully collects specific data to evaluate certain outcomes).
It *could* be a subtle difference, if they employed a proactive follow-up protocol with all patients…but it seems that they relied upon post-op visits to the institution. This speaks to his 4th limitation where he notes the retrospective nature of the study not necessarily reflecting the true rate. It seems like a very good result if the observed rate is a close approximation of the true rate…we just can’t be too sure how close it is.
Also worth noting the inguinodynia analysis consisted of 838 patients, all of whom received an open Lichtenstein repair.
Only nine patients had a lap repair…and if those were included in the analsysis, than having a lap repair would also be predictive for inguinodynia (but that is a very small number of people so we should not infer anything from that)
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Slight clarification to above…it covers 953 hernias in 874 patients.
Statistically significant predictors of inguinodynia were younger age (54 vs. 61yr old), smoker at time of operation, history of prior contralateral repair, and postoperative complication.
Cumulative post-op problems were 11.9% (urinary retention, post-op pain that is not chronic, seroma, site bleeding, etc)…and 12 had inguinodynia, 10 had recurrences.
There is a lot more to the study, including some discussion of inguinodynia…he cites the low rate here as perhaps due to “1) a standardized technique with division of the inguinal nerve when encountered; (2) an almost exclusive male cohort of patients; (3) an older patient population; and (4) the retrospective nature of our study and not a true reflection of the actual rate.”
“It is unclear if dividing the ilioinguinal nerve reduces the rate of inguinodynia. Three randomized trials have addressed inguinal neuronectomy to prevent inguinodyania. Two had favorable results, and one argued against it.”
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For what it’s worth, the first link covers 953 of his repairs between 2005 and 2015…patients were 99% male, same avg age and confidence interval.
I pulled that article too…he used general anaesthesia in vast majority…99% were open, with lap reserved for bilateral, recurrence, or both. Worth noting their reporting system captures a pile of data…56 variables includes various dates, operative details, hernia characteristics, demographics, drinking and smoking history, co-morbidities, and outcomes.
He describes his repair in some detail. For the vast majority that were open repairs, the mesh part:
“The floor is then repaired with a 6.0 × 3.0 inch propyprolyne mesh (ETHICON Inc.) that is cut in a cone configuration to accommodate the size of the inguinal floor by crating tails around the cord structures. This is secured laterally to the shelving edge of the inguinal ligament with 0-polydioxanone in a running fashion and medially to the conjoint tendon with interrupted 0-ethabond sutures”.
For the 1% of repairs that were lap: “A piece of (small, medium, or large) mesh (Knitted Polyprplylene Pre-formed Mesh; Bard #DMax Mesh; BARD Davol, Inc; Warwick, RI) is introduced and placed in such fashion to cover the myopectineal orifice. It is tacked to the pubic tubercle and Cooper’s ligament medially and laterally to the abdominal wall musculature anterior to the superior iliac spine with a 5-mm absorbable fixation device (AbsorbaTack [ABSTACK30X] COVIDIEN; New Haven, CT).”
Inguinodynia was defined as postoperative pain persisting beyond 3 months after surgical intervention. Data regarding this information were extracted from CPRS by P.M.P. who was unbiased to the patient population or the operation.
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He does not define inguinodynia in his letter.
He does not disclose what % of his repairs were mesh or tissue, though my suspicion would be that the majority of them are mesh, given that he cites an avg patient age of 60.4?±?1.4 years.
To expand on that, he says that he does Shouldice on younger patients with an indirect hernia, and also notes that younger patients in his practise are more likely to have inguinodynia (he does not link that to the tissue repair though).
His unusually narrow age range is likely due to his practise being located in a Veterans Affairs hospital. It is a letter to the editor, not a journal article, so the data and methods are not detailed. I’m simply including exactly what data he provided which was avg age (and confidence interval), and total number of repairs.
Looking at his numbers over that timeframe, he is clearly a specialist but perhaps not a ‘high volume’ specialist in comparison to what some surgeons do…but likely ‘high enough’ to at least partially explain why his chronic pain outcomes are better than average (he doesn’t cite his recurrence rate, merely noting that it does not differ between his mesh and tissue repairs).
As we have suspected for a while now, surgeon skill and experience (volume) is are likely key factors in achieving above avg outcomes, regardless of repair type.
To publish his full data in a study, he would have needed consent from his patients and ethics board approval through the hospital, though he notes “…part of these data has been published previously”.
Among his seven references are three studies he was involved in:
https://www.americanjournalofsurgery.com/article/S0002-9610(16)30193-3/fulltext
https://www.americanjournalofsurgery.com/article/S0002-9610(08)00598-9/fulltext
https://www.journalofsurgicalresearch.com/article/S0022-4804(19)30162-3/fulltext
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It’s not long (my summary is barely shorter, but for the sake of not violating copyright…)
It’s a letter to the editor from S. Huerta, Department of Surgery, VA North Texas Health Care System, University of Texas Southwestern Medical Center
– Best estimate of incidence of inguinodynia is 10%, but widely ranges between institutions (0-64%).
– Has done 1805 open (tissue and mesh) inguinal repairs in his practice since 2005, which is in a VA hospital with a closed system, so complications are dealt with in-house.
– Patients are all older vets, around 60yrs old with little variation in age, and he cites a rate of inguinodynia of 1.7%.He does the following to keep that rate low:
1. Watchful waiting, especially for younger patients, because many with inguinal pain don’t have a hernia, so surgery should only be done when hernia presents itself over time.
2. Elective ilioinguinal neurectomy. Cites meta-analysis of 16 RCTs comparing it with nerve preservation that found a significant reduction of inguinodynia at 6 months (9% vs. 25%), but no statistically significant difference at 12 months (9% vs. 18%). He electively resects the nerve, particularly in young patients, but elects to preserve it in cases where it is not readily identified (i.e. not typically located).
3. Cuts mesh to fit the inguinal canal of each patient, as it is possible (but not confirmed) that inguinodynia results from nerve entrapment following inflammatory reaction to mesh…less mesh, less likely to have reaction. He has used the same proline mesh since 2005.
4. Tissue repair. No one strategy fits all. Does Shouldice repair on young patients, with recurrence no different than mesh, because even if risk of recurrence was greater, can do posterior recurrence repair when they are older.
5. Smoking cessation – cites study that smoking is predictive of inguinodynia, so highly recommends his patients to stop six weeks prior to repair.
– notes that while intro of mesh has reduced recurrence rates overall, tissue repair is still appropriate for some cohorts.
– notes Desarda has similar recurrence to Lichetenstein, but carries lower inguinodynia risk.
– Can’t release his data due to privacy/legal reasons. -
I would still strongly consider dynamic MRI done in the U.S.
Dr. Kang says MRI is not necessary for his purpose…but remember that his purpose is to diagnose inguinal hernias. What if you don’t have a hernia?
I believe that the advantage of MRI is not only it’s demonstrated benefit in diagnosing hidden/occult hernias, but also the information it could provide if you don’t actually have a hernia.
I think this is partly why Dr. Kang (or Stephen) is cautioning that you might travel to Korea for ‘nothing’ if their dynamic ultrasound does not reveal a hernia. I’m certainly no expert in imaging techniques, but I don’t think they are in as good a position as someone using dynamic MRI in terms of diagnosing other potential problems…but perhaps you can clarify that with them and Dr. Towfigh (if she is the one you are considering for dynamic MRI, which I think would be a very good idea).
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It is absolutely possible to have a hernia without a bulge. A hernia may also not be palpable upon physical examination. These are typically called occult or ‘hidden’ hernias.
There has been discussion about them here, and Dr. Towfigh and her colleagues have published papers about them with regard to imaging:
https://doi.org/10.1001/jamasurg.2014.484
https://doi.org/10.1016/j.jamcollsurg.2018.08.003 -
More on your concerns…and follow-up improvements!
“Likely, the most important limitation of this study is the incom- plete story of postoperative long-term complications. The main marker of success in hernia operations is classically low recurrences rates, even though low rates of chronic pain and higher-quality life outcomes are recently gaining attention and are becoming equally important markers of long-term outcomes [35, 36]. A patient-reported outcome measures system (PROM) is in the implementation phase in this institution and may allow a more reliable update in all our outcomes in future studies.”
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Yes, there is a bit more info on that.
“Reoperations after Shouldice repair and open mesh repair presented markers for higher surgical difficulty (longer operative time, higher identification of heavy scarring, less nerve identification, and higher frequency of intra-operative consultation) when compared with other techniques (Table 3). Therefore, an empirical timeframe of five years from the index operation (0–5y: 109 patients; > 5y: 99 patients) was tested for the same markers.”
They looked at surgical site occurences of hemotoma, seroma, cellulitis, and wound infection (and the total for all of these post-operative combined complications). Despite the additional complexity associated with Shouldice and open mesh, there was only one post-op complication of a seroma with Shouldice and one case of infection with open mesh, neither of which equated to statistically significant differences from the recurrence repair outcomes of the other primary repair types.
They are indeed just talking about post-op complications, so this doesn’t include any long-term follow up for things like another recurrence, chronic pain, etc.
This is in line with their two study objectives: 1. pattern of recurrence by primary repair type and 2. surgical site occurrences following open recurrence repair by primary repair type.
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The article terminology is not imprecise…they distinguished between primary repairs of Shouldice, open tissue, and open mesh.
Shouldice very rarely uses mesh for primary inguinal hernia repairs (less than 0.1% of all cases, and almost never for primary indirect). When they do use mesh it is almost always for recurrent hernias, incisional hernias, most femoral hernias, and large umbilical hernias. This comes directly from them.
IMHO, it is far more reasonable to assume that they would have noted any cases of primary Shouldice repairs that recurred and which had used mesh than to assume both that are cases of mesh included in that category AND that they failed or chose to not differentiate between them and ‘proper’ Shouldice repairs.
What is particularly arrogant and dismissive though is your sweeping characterization “making the research inconclusive”.
I’m not getting into the rest…you’re repeating yourself and I already acknowledged that a summary may have been provided on the site rather than a transitional abstract, which I would not have known because I was logged in with my credentials and thus immediately see the full study. I apolgized for that oversight if it was indeed the case.
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That makes sense – while they noted no difference in short-term outcomes between low- and high-complexity recurrence repairs, they suggest that may be at least in part to their allocating the more complex cases to senior surgeons, the in-op consult option for juniors, etc…however, that skill/experience is not available everywhere, so if an ‘easier’ repair option is available (and widely available), it makes sense to consider that option.
That same logic could indeed apply to more complex or higher risk primary repairs, like larger hernias. Patients should be made aware of how THEIR hernia and overall situation relates to various repair options so that they can make a more informed choice. From strictly a recurrence standpoint, I suppose one potential benefit of going with tissue repair, like Shouldice, is that a lap mesh recurrence repair would be considered ‘easy’? Whether the potential benefits of possibly avoiding mesh in the first place are worth any unique risks of complications going with the more complex repair to see if it ‘sticks’ is debatable and we don’t have any good data on that yet, AFAIK.
I share that sense of mystery (a ‘healthy skepticism’, you might say) with Dr. Kang’s perspective. I’m all for whatever works best, so I do hope we see reliable, published data at some point.
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I couldn’t edit my prev post – if you are able to see a larger summary than just the typical abstract (as some journals offer that), then my apologies for referring to just the abstract.
I was already logged in so that I could access the full study, so I didn’t see whatever someone sees in front of the paywall.
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@pinto – I’m not sure what is being conflated in the study?
How are tissue and mesh being lumped together under ‘open’ if the categories they used in this study to classify primary repairs included ‘Shouldice’, ‘open mesh’, and ‘open tissue’?
I’m well aware of what an abstract it…and what it is not. My advice stands: If an abstract suggests a study may be of interest, then read the study. It is then appropriate to present whatever comments, criticisms, questions, ideas, etc. that you might have regarding it.
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@mark – glad to hear your tissue repair went well and has held up for 2.5 years and counting, with no ill effects. I had similar experiences, but a long time ago at Shouldice, and I too am glad that I did not proceed with a lap mesh repair from the general surgeon to whom my family doc initially referred me.
You might consider starting a new thread and (if you don’t mind) sharing the name/location of your surgeon and the type of repair you had. It might be helpful to those seeking a tissue repair as it can indeed be hard to find or travel to a good surgeon who offers them. Cheers!
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Watchful, I agree – I am glad to see that not only are they using data and evidence-based decision making to potentially shift their ideology and approach, but that their own surgeons remain actively engaged in the research.
With so many surgeries performed at Shouldice Hospital, there is a wealth of data and experience that should continue to be leveraged to help guide the field going forward, in conjunction with ongoing research, including what is coming from other highly skilled/experienced surgeons (like the Germans).
I do like that the view is changing on large hernias. It was interesting to note in the consensus paper that we have discussed here (https://doi.org/10.1007/s10029-020-02365-6) that only two of the 12 surgeons polled suggested that ‘all hernias’ was the ideal indication for a Shouldice repair, with the others being more conservative in their responses, suggesting the ideal is for smaller hernias, particularly for younger people. Also interesing that two of the 12 were from Shouldice, though we can’t know for sure if they were the two who said ‘all hernias’.
(Which is not to say that the majority feel it is inherently inappropriate for larger hernias, or even that it may not remain the ‘best’ option for larger hernias for some people…but, at minimum, that they believe its ideal indication is for smaller hernias…though this could even be true for all repair types, that larger hernias are less ‘ideal’ indications period – all of this nuance is very important to explore and acknowledge).
The nuance in this potential shift is interesting too…part of it, which is explicitly discussed in this most study by Netto and his colleagues, appears to be due to the fact that the majority of hernia repairs are not carried out in high-volume specialty centers like Shouldice Hospital…so a question remains as to how much of the shift is based upon ‘we don’t think a Shouldice repair is the best option in certain cases’ vs. ‘we recognize that the expertise of our senior surgeons, who can competently tackle high-complexity cases, is not found everywhere else, so it is better to advocate for a lower-complexity repair in the hands of a skilled surgeon that is more widely available’.
Your experience and conversations with your surgeon suggests that it is at least some mix of the two…that even internally, they are more recognizing that other options may be better in certain cases (which they have always done to *some* extent, even simply by virtue of their narrower patient profile, but this now seems to be shifting further based upon data and clinical experience).
Somewhat of a contrast, Dr. Kang seems to remain confident that his approach remains appropriate for all inguinal hernias (or has he said anything more on this?), even regardless of tissue quality, BMI and most other patient characteristics. I really hope we get some reliable data from his extensive work.
Interesting times in he tissue repair space…
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The study claims that there were no complaints of reduced sensation in the scrotum or inner thigh as a result of dividing the nerve, which they did in all cases where it was normally located.
Again, given that this seems to have relied on patient complaints rather than confirmed via comprehensive long-term follow-up, it is tough to say whether there were indeed zero problems.
From all we have learned thus far, I’m very inclined to agree with that last part of your post. Surgeon skill and experience not only appears to be important regardless of procedure, it could indeed be the most important variable, more so than the type of procedure.
I’d chose a lap mesh repair from a high-volume specialist rather than a tissue repair from someone who infrequently performs a small number of them (and vice versa)…but all else being equal (or ‘equal enough’), I’d still rather avoid the potential problems of mesh and would choose a tissue repair.