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Experts question MBSAQIP conclusions regarding SLR
A paper reporting on the surgical techniques from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database and published in the Annals of Surgery, has received some criticism from bariatric experts on its conclusion regarding staple line reinforcement (SLR).
The study, ‘The Impact of Different Surgical Techniques on Outcomes in Laparoscopic Sleeve Gastrectomies: The First Report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)’, compared different techniques used in the procedure on 189,477 cases performed by 1,634 surgeons at 720 centres between 2012 and 2014. As part of the research, the researchers evaluated staple-line reinforcement, oversewing versus stapling alone, as well as bougie size and stapling distance from the pylorus. The aim of the study was to assess the impact of these techniques on 30-day complication rates, and one-year weight loss.
Although the experts praised the researchers and the report, they highlighted several methodological shortcomings of the study, which they claim, limits the conclusions with regards to SLR that can be drawn from the study. Indeed, the authors of the report acknowledge that: “There are additional surgical techniques (ie buttressing of the omentum to the staple line or use of other hemostatic clips or agents) that could impact leaks and bleeds…The lack of granular information including the type of SLR or stapler also limits the conclusions that can be drawn from this study.”
Whilst discussant, Dr Philip Schauer (Cleveland Clinic, OH), congratulated the authors on “probably the most scientifically robust assessment of these technical factors in sleeve gastrectomy,” he did express some surprise and expressed the reservations he had on some of the paper’s claims. For example, he questioned the report’s suggestions that SLR with buttressing material appears to actually increase instead of decreasing leaks, and that this technique has a modest effect, if any, on bleeding rate given that the material is supposed to decrease leaks. He said that he would like the authors to be more specific concerning the technique SLR oversewing (continuous oversewing, interrupted sutures, number of sutures), as well as the type of material and its placement.
In conclusion, he asked whether the authors could stand by their data, and thereby suggested “that surgeons should abandon SLR because it yields a worse outcome and it costs more money?”
In response, study author Dr Matthew Hutter, Massachusetts General Hospital, Boston, MA, acknowledged that the study did not specify the type of suture, the technique or type of SLR (eg synthetic, bovine pericardial strips, etc), thereby limiting the study.
Nevertheless, he added that the authors were happy to stand by their conclusions and given the large sample size (almost 190,000 cases) and the fact this is real-world data, the report “should impact which techniques are used by surgeons.”
In a letter to the editor, ‘Impact of Different Surgical Techniques on Outcomes in Laparoscopic Sleeve Gastrectomies: Role of a Registry-based Observational Study,’ published on 10th March 2017 in the journal, Dr Fabio C Campanile (Andosilla Hospital, Civita Castellana, Italy), said that the study highlights the strength and weaknesses of registry data, even if well conducted.
With regard to buttressing products he said that numerous studies either show the absence of significant differences between reinforced and non-reinforced patients or a reduction in the leak rates when buttressing is used. He also cited the lack of clarity concerning they type of bioabsorbable or non-absorbable buttressing material used, adding that it was unfortunate such details were not collected.
He summarised that the conclusions of the study “may be compromised by unmeasured confounders, the absence of relevant data or their heterogeneity.”
In a second letter to the editor, ‘Impact of Different Surgical Techniques on Outcomes in Laparoscopic Sleeve Gastrectomies: First Report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)’, Dr Jamie Ponce (past-president of the ASBMS) said that “the authors of the article should be congratulated for organising, compiling, and analysing the largest sleeve gastrectomy registry, a significant accomplishment for all the individuals that contributed.”
However, he did disagree with the view that “SLR is associated with increased leak rates,” without the researchers adding that future studies should be carried out to investigate “the factors and variables associated with the apparent increased leaks in SLR cases.”
He concluded that “four out of five MBSAQIP surgeons use SLR at some point, and if the conclusions are read as they are, will affect the majority of the surgeons’ technique. Many of them will be managing staple line bleeding in different ways adding potential factors that can affect outcomes…The readers and public should be cautious about using the incomplete data to dictate health care policy and patient care.”