MarkT
Forum Replies Created
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It is a great question.
Generally speaking…permanent sutures, and either stainless or Prolene would be fine (maybe very long term resorbable might be ok too)
I too am intrigued by longer term resorbable meshes being developed, but need to learn a lot more about them.
To be quite honest, I don’t know nearly enough about the various options, products, etc. and freely admit that I am very biased in favour of tissue repair by a high-skill/volume specialist.
In addition to my lack of knowledge regarding mesh repairs and products, I also don’t believe we have sufficiently great data (especially long-term data), that would leave me feeling very confident in making a decision for myself at this moment if I had to get a mesh repair.
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@Mark T, are you Swedish btw, is that why you’re arguing: “This study is therefore quite relevant to hernia patients in Sweden” (as you stated in a related thread).
Why would you ask if I am Swedish? I said it is quite relevant to hernia patients there, because the sample covers almost 98% of repairs in their country…while you are suggesting the study is “biased” and “irrelevant” (your words).
They plainly state that nearly half of the 22,000 cases had surgery performed by a surgeon with a load less than 26 a year. That should raise a red flag. Apparently the researchers assume surgeon load is a minor factor as they provide no other information for the upper range of surgeon load. That raises an alarm because the database has all that info.
Why should that raise a ‘red flag’? They are responsibly disclosing specific and relevant details about the surgeons. They clearly do not assume it is a minor factor, because they included surgeon volume as a variable.
How comical that you only now criticize them for not providing the upper load (which is what *I* noted and your response was “The fact that the median surgeon load is 25 means that the range is zero to 50!”. . At least you understand what the median is now, I guess? But now you are just parroting something that I said!
“They describe pure tissue repair cases as outside of the framework of this study apparently because as they say “there were very few recorded in the register.” “Very few” of course is vague. Why not state the number? It actually could be nearly 2,000 cases based on their account how the cases came to total 22,000.
We can deduce that it is nowhere near 2,000 tissue repair cases considering three of the five repair groups had fewer cases than that (Open anterior: 18,034; TEP: 2,688; TAPP: 380; CAP: 1022; and OPPM: 793). You would know this if you actually read the study. Instead, you strangely surmise they might be biased against tissue repairs (?).
The upshot is that the elephant in the room is ignored by not considering the effects of surgeon experience.
They did consider this. Re-read my posts. I included some concerns/questions about how it was considered though.
I don’t know what else to say…you simply don’t understand the methodology and are not taking the study within its proper context.
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Will give this a good look later…but he talks about risk factors, prevention, patient evaluation, and treatment options (medical and surgical) including medication, physical and psychological therapy, nerve injections, ablation, neurectomy, and mesh removal.
One the ‘key points’ states that 90% of surgery patients see an improvement in their pain, though in the paper he expands on outcomes:
“Fafaj and colleagues reported on the outcomes of surgical intervention for CPIP and found that more than 90% of patients had improvement in their pain and would have mesh removal or neurectomy again. It should be noted that although more than 50% of people will get near resolution of their pain, only 10% achieved complete resolution”.
(The link for that study follows…results are based on a small sample of 29 patients: https://doi.org/10.1016/j.amjsurg.2019.10.020 )
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I discussed this study at more length in the other thread. I’m not sure what has been ‘turned upside down’. Much research points to inexperienced surgeons failing to replicate the outcomes of high volume specialists.
“Shockingly I found a highly touted medical study of 22,000 cases aimed to provide data for chronic pain etc. was fully based on surgeons with low-volume loads (50 or less a year)”.
It is not correct to assume it was ‘fully based’ on low-volume, 50 or less. The study also needs to be taken in its proper context. Per the paper, the data is based on the Swedish Hernia Registry, which includes almost 98% of all repairs performed in the country during that time period. This study is therefore quite relevant to hernia patients in Sweden.
It is not relevant to us on this forum, because we will all choose (or have chosen) a high-volume specialist.
“Even the most experienced were only doing approximately 5 hernia surgeries a month…”
We don’t know that from what is presented in the study. Knowing the median is only knowing the middle data point. Alone, that does not reveal the range of the data or the shape of its distribution.
Even taking this study in its proper context, it is important to note that there is only a 1yr follow-up period, which we know is inadequate for judging long-term complication rates of chronic pain and recurrence. The prevalence of complications is therefore almost certainly underestimated (and probably by a wide margin, based upon other research that suggests a significant % of complications present years later).
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It is not biased or irrelevant, per se…it just is not relevant for our purposes, since we would all go (or have gone) to a high-volume specialist.
Pretty typical in that they ultimately got data from 65% of people (the 75% figure is only the survey response rate) who had repairs over that 2.5 year period…and they report characteristics of responders and non-responders to check for differences.
“Sutured repairs were excluded as there were very few recorded in the register”…that makes me think very few are performed there, since the register is said to include almost 98% of all repairs performed (it would be nice to know the breakdown of the 2% that aren’t covered by the registry though).
Interesting notes:
– Data is entered in real-time by the surgeons, so there is presumably very little missing data or inconsistencies in measurement between surgeons/sites.
– Open anterior mesh was by far the dominant repair method (78.7%)…much smaller group sizes for all other repairs (as low as 1.66% for TAPP). Important to keep in mind.
– One of their data points was surgeon annual volume, and a little less than half (48%) of respondents’ repairs were performed by a ‘low-volume surgeon’, defined as performing less than 26 repairs per year…but we need more info on that distribution of volume…i.e., is it roughly normal or does it skew upward at some point (and at what point) beyond the median? That would affect the interpretation of results on the influence (or lack thereof) of that variable.
– While chronic pain was defined as “pain persisting for more than 3 months, affecting everyday activities”, they actually looked at groin pain persisting after one year…however, this is still *much* too short of a timeframe and complication rates are definitely understated here. Another thread has a study were WAY longer timeframes are demonstrated to be necessary.
– There wasn’t that much difference in pain by technique, despite the statistically significant result of ‘less pain with TEP’ vs. open anterior mesh, and TEP was associated with much higher risk of recurrence.
What I found most interesting is that they don’t discuss surgeon volume in their analysis or their results. They initially included a bunch of variables in their initial model, then used a ‘backward elimination process’ (i.e. progressively removing variables in a series of models, based upon which ones offer the least explanatory power on the outcome variables of pain and recurrence) to eventually arrive at their final model that only included repair type. While this implies that repair type explained more variance than did surgeon volume, it doesn’t necessarily mean surgeon volume was insignificant (though presumably if it was, it would have been retained). On the surface this is surprising given that nearly half of all surgeries were performed by low-volume surgeons, but we still don’t know what the distribution looks like, so it’s hard to comment.
Annual volume was included as a dichotomous variable of ‘above or below median’. Normally we would like to at least know what the median is, but because almost half were ‘low-volume’ (<26/yr), it gives us *some* idea…even still, it would be nice to see what the distribution looks like…a normal vs. skewed distribution would affect interpretation.
Interesting study, on the whole. The follow-up times are still much too short, unfortunately…but the presumed consistency of the registry data with real-time entry, its inclusion of about 98% of all repairs performed, and at least some accounting for surgeon volume (even if that variable and its influence could be more clear), seem to be advantages over many other studies.
But yes, it doesn’t really help us here though…we are primarily interested in data coming from high-volume specialists. It is relevant for the general population though, since most people don’t go to high volume specialists for their repair.
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I pulled a copy of the 2007 British study
https://academic.oup.com/bjs/article/94/5/562/6142702Results (median 52 months follow-up)
Shouldice (74 repairs): six recurrences, eight cases of suprapubic numbness, and one of scrotal numbness.
Lichtenstein (76 repairs): one recurrence, one case of suprapubic numbness, and 10 cases of scrotal numbness.
TAPP (81 repairs): one recurrence and one case of lateral cutaneous nerve damage.We’re talking about rather small sample sizes here.
“The increased rate of recurrence after Shouldice hernia repair during long-term follow-up has been reported in several studies 15–17.”
The first of those citations is a study whose purpose was “to investigate whether an alteration in type I and type III collagen synthesis, amounts of MMP-1 and MMP-13 and the expression of fibronectin were associated with the development of inguinal hernia”. They looked at the hernia sacs of 23 patients. No full article…but this is not a primary source discussing recurrences after Shouldice repairs.
The second citation is a study concerning short- and long-term absorbable meshes, and I was able to pull a full copy. The word ‘Shouldice’ is not found in the entire article and their experiment involved comparing short- and long-term absorbable mesh in rats…?
The purpose of the third was “to investigate the collagen matrix in recurrent inguinal hernias”. I pulled a full copy of this one too. Again, the word “Shouldice” does not appear in the entire article. They do refer to six studies that discuss repairs and recurrences, but I’m just not willing to pull all six of those to get details.
The authors should be citing the primary sources and then noting the secondary ones citing those sources. It is extremely lazy to send the reader on a chase to verify those claims, especially when there cited studies in turn (allegedly) point to other studies that supposedly state what they are claiming.
“A recent 10-year follow-up study showed a recurrence rate of 7·7 per cent after primary hernia and 22 per cent after recurrent hernia repair 18”.
I pulled that citation too, since those figures seem high. It was a retrospective study that looked at 229 patients who had 293 inguinal hernias repaired in 1992 by the Shouldice technique in University Hospital Aachen, Germany, with a 10yr follow-up period.
Only 31 patients had a recurrent hernia repair…so the 22% figure cited is based on 7 out of 31 people experiencing a recurrence. This does not seem like a terribly representational study from which a recurrence rate should be attached to the Shouldice technique…but there seems to be more.
The authors of that study state their repair details were described in a previous paper…so I pulled that one too. Unfortunately, the full text was in German, but the English abstract included: “For all primary hernias and indirect or small recurrent hernias a modified two-layer Shouldice repair of the transversalis fascia using a monofilament running suture (Polypropylene 0) is recommended.”
So they use a modified two-layer repair? Is that is what the originally stated recurrence rates for ‘Shouldice’ are based on?
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“It seems like nearly everyone that has a pure tissue repair has some level of chronic pain…”
That is undeniably false, Chuck. Why are you still making irresponsible claims like this? You are doing a disservice to this community.
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Yes…and the insufficient follow-up time (1yr for pain, 2.5yr for recurrence), which is a common issue across many studies, remains a concern too.
Since we know that many post-op complications will materialize beyond those stated timeframes, the pain and recurrence rates here are almost certainly understated.
It would be great for a study like this one, where such a high % of hernia repairs carried out in the country are covered by the registry, where everyone uses an easily trackable personal identifier to access healthcare, etc. to continue to track this sample for a longer period of time. There would presumably be much less patient attrition vs. a similar study carried out in the U.S., for example.
Of course that is expensive, time consuming, etc…but it could yield some useful and more accurate data.
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Yes, the 98% figure was from a ’98 study, and the data from the study here is from 2012-2015; however, “Today more than 90 units are members and almost 100% of all hernia repairs performed in Sweden are registered. A database covering more than 200 000 repairs has been assembled.”
Keep in mind that residents all use a national id card to obtain universal healthcare there…and that nearly the *vast* majority of people fall exclusively under the public system…so it would presumably be rather easy to debunk this statement if it were inaccurate.
If the 90 clinics covered only represent 10% of all medical clinics in Sweden, then it seems more logical to conclude that the other clinics are not performing hernias (or are performing *very* few of them) than to assume this statement misrepresents the % of repairs covered.
Yes, it’s voluntary database…but consider the context of the country’s healthcare model, size/population, gov’t structure, patient mentality, etc., all of which are extremely different than the U.S., for example, where a similarly voluntary database is surely going to result in a much lower participation rate among providers for several of reasons.
I don’t see a great reason to doubt the claims of the registry…certainly not to the extent that I would characterize the study as ‘biased’ or ‘narrow’.
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Of course this study needs to be taken into its proper context…as does every study.
This is science…it is important to ‘quibble about the numbers’ and not make assumptions. There can be a world of difference between two data sets with the same median, depending upon the range of their data and the shape of the distributions. That is simply a fact, not merely my opinion.
If the majority of surgeons covered in that study are indeed low-volume, with only a very small number of higher volume ones, then it would speak precisely to my stated concerns with how the variable of surgeon volume was treated. If there are zero high volume, and the distribution of annual volume is approximately normal, then it is *much* less of an issue. The point is, we don’t know from what info is provided.
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The study used data from a national registry that covered nearly 98% of all hernia repairs performed in the country during that time period.
It is the opposite of ‘narrow’.
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“None of these products have been removed from the market. There has to be a long-term strategy. What could it be?”
This is appalling…and that Bard is still using the design with new products, per Dr. Towfigh’s post, is just deplorable.
It’s sad that regulatory oversight is so lax…and that legal recourse will take years and cost a small fortune, to wind its way through the system, all the while patients continue to suffer.
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Pinto, how is that correct?
The median is simply the middle data point…it does not tell us anything about the range of the data or the shape of the distribution. I’ll give examples if you want.
I’m not sure how it is biased since the study includes nearly ALL repair data for the entire country. As I stated (from the paper), the Swedish Hernia Registry includes data from almost 98% of hernia repairs performed in Sweden during that time period. The likelihood of bias when only 2% of repairs are excluded is rather small (but, as I said, it would be very nice to know the nature of that 2% not covered).
They did not exclude surgeon volume from their analysis…they excluded it from their final model (very different). They fit a series of models and progressively removed variables that didn’t offer explanatory value. By virtue of not including it in their final model, the implication is that surgeon volume did not offer as much explanatory power in differentiating between groups as did repair type. I would still like to see some discussion of the models that included surgeon volume…some details on how little the final results changed by that variable’s inclusion and exclusion.
Again, my real concern is they way they operationalized that variable…they chose to code it as ‘above or below median’…however, again, the median is merely the middle data point and tells us nothing about the range of surgeon volume or the shape of the distribution of surgeon volume. All we know is that roughly half had repairs from their definition of low-volume. That is not enough info, IMHO, to judge whether that was the best way to treat that variable.
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Yes, you are correct…I had meant to edit that to say the 2007 British Journal of Surgery study (not 2007 British Study)
The problem goes much deeper than the setting, though that is a big deal on its own. The total # of patients getting a ‘Shouldice repair’ (modified repair, it seems) at that hopsital is about one third of what ONE full-time Shouldice Hospital surgeon would do in a year. To be fair, they are not mere ‘generalists’ doing very few repairs, but they aren’t doing as many as the high-volume specialists either.
IMHO, a bigger problem though is that the results perpetuate in future papers with ZERO context…and then readers come along and fail to evaluate the quality of that ‘evidence’.
It is extremely problematic to say “A recent 10-year follow-up study showed a recurrence rate of 7·7 per cent after primary hernia and 22 per cent after recurrent hernia repair” with no further context…and when digging deeper you find out those percentages are based on an extremely small sample size and (apparently) a modified repair.
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No, you have not. You’ve been in echo chambers on social media groups looking at non-respresentative problem cases.
The 27% study is NOT from Shouldice Hospital, the Germans, or anyone else who is an ‘expert’ with that repair, is it? Then that would be non-representative too.
Even if we granted a 27% pain rate, how does 27% = the “nearly everyone” claim from your irresponsible opening post?
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It would be nice if it were possible to establish some reliable diagnostic criteria, given that most surgeons are not able to perform all types of repairs with the highest degree of skill (rather than have surgeons just impose whichever repair they do best or where individual surgeons tailor repairs to their patient, despite not being the ‘most’ skilled in all of them).
With a diagnosis of what the ‘most appropriate’ repair might be, patients could then choose a surgeon to do that repair.
Maybe that is wishful thinking though…
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“A difficult and long surgery is more likely to cause chronic pain and other complications.”
While this seems logical, we still need better data to flesh out the details, because that relationship may depend (change) based upon certain factors (as is thought to be the case in this study).
While it is undoubtably much easier to deal with short-term issues like surgical site complications vs. long-term issues like chronic pain, it would still be really nice to get some nuanced data to see what sort of variables (like surgeon skill/experience) might influence those outcomes and therefore inform policy in both high-volume specialty centres vs. the broader hernia repair space.
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The study is not ‘inconclusive’…you don’t know what you are talking about.
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Yes, recurrence has long been the primary barometer of success, they note…but of course recently chronic pain has become more widely acknowledged, especially the apparent underestimation of its prevalence.
That is disappointing to hear if the follow-up process is so tedious that it is discouraging participation. As it is, most long-term studies suffer from much participant attrition…every effort should be made to make it as simple and convenient as possible to keep people involved.
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Most importantly, this ‘alleged’ conflation would not appear to alter the results anyway…so terming the research inconclusive seems quite inappropriate.
The first study objective was to look at patterns of recurrences by primary repair type…and both Shouldice and open mesh are implicated as ‘higher difficulty’ on a series of markers, but neither were implicated with worse early outcomes. The actual numbers might shift slightly on these markers if a few mesh cases were lumped in with Shoudlice, but it would be *highly* unlikely to alter the broader results. There would need to both be a large number of mesh cases included AND those mesh cases would need to substantially differ from the ‘regular’ Shouldice cases.
Any potential conflation would actually have no bearing on the results for their 2nd purpose (looking at surgical site complications following recurrence repair, by primary repair type), because there was only one complication for the entire Shouldice group (and only one in the open mesh group).
I.e., IF there was a conflation, and IF there were mesh cases in the Shouldice group, it would only have mattered if there were a bunch of post-op complications and this exceeded what was seen for the other groups, because then we wouldn’t know whether to attribute that to the Shouldice repair type or the use of mesh in some cases.
Terming the research ‘inconclusive’ because of your perceived conflation is just not appropriate here, IMHO.