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Navigating uncharted territory in surgical innovation: systematic review of non-standard metabolic bariatric surgery
Francesco Saverio Papadia1, Ottavio De Cian2, Nicola Di Lorenzo3
1Department of Surgical Sciences and Integrated Diagnostics (DISC), School of Medical and Pharmaceutical Sciences, University of Genoa, Genoa, Italy.
Background:
Surgical innovation often outpaces robust evaluation. This study used metabolic bariatric surgery (MBS), a field of high-intensity innovation, as a case study to evaluate reporting standards and ethical oversight for experimental procedures within surgery.
Methods:
A systematic review was conducted in accordance with PRISMA 2020 guidelines. PubMed/MEDLINE, the Web of Science, Scopus, the Cochrane Library, and Embase were searched from January 2000 to December 2024 using terms related to MBS, surgical innovation, and non-standard intestinal bypass procedures. Original studies reporting first-in-human or early clinical series of non-standard primary MBS involving significant intestinal modification were included and reviews, editorials, conference abstracts, revisional surgery, purely restrictive procedures, and device-based interventions were excluded. Two reviewers independently screened studies, extracted data on publication timing, patient numbers, follow-up, ethical approval, and trial registration, and assessed risk of bias using the Newcastle-Ottawa scale (NOS), the Joanna Briggs Institute critical appraisal checklist, and the ROBINS-I tool.
Results:
From 57 included studies (10 754 patients), the median time from first human operation to publication was 5 (interquartile range 3-8) years. The median initial cohort size was 39 (range 1-1074) patients. Institutional Review Board or ethics committee approval was reported in 47 of 57 studies (82%), while prospective clinical trial registration was documented in only 6 of 57 studies (11%). Methodological quality was low (mean NOS score of 5.0 out of 9), with 56 of 57 studies judged at high risk of bias. Out of 57 studies, only 15 (26%) reported outcomes at ≥3 years and only 8 (14%) reported outcomes at ≥5 years.
Conclusion:
This MBS case study reveals delayed publication and a widespread lack of prospective trial registration, exposing over 10 000 patients to experimental procedures outside a transparent research framework. These findings highlight a systemic failure in surgical innovation governance and underscore an urgent need for a cultural shift towards mandatory, prospective oversight frameworks to ensure patient safety and credible evidence generation.
