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- Caron, Bénédicte, et al.
(författare)
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IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis : the PROCTRIAL Consensus
- 2022
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Ingår i: Clinical Gastroenterology and Hepatology. - : Elsevier. - 1542-3565 .- 1542-7714. ; 20:11, s. 2169-2627.e1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND AIMS: Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the PROCTRIAL (Definition and endpoints for ulcerative PROCtitis in clinical TRIALs) initiative was to develop consensus statements for definitions, inclusion criteria, and endpoints for the evaluation of ulcerative proctitis in adults.METHODS: Thirty-five international experts held a consensus meeting to define ulcerative proctitis, and the endpoints to use in clinical trials. Based on a systematic review of the literature, statements were generated, discussed, and approved by the working group participants using a modified Delphi method. Consensus was defined as at least 75% agreement among voters.RESULTS: The group agreed that the diagnosis of ulcerative proctitis should be made by ileocolonoscopy and confirmed by histopathology, with the exclusion of infections, drug-induced causes, radiation, trauma, and Crohn's disease. Ulcerative proctitis was defined as macroscopic extent of lesions limited to 15 cm distance from the anal verge in adults. Primary and secondary endpoints were identified to capture response of ulcerative proctitis to therapy. A combined clinical and endoscopic primary endpoint for the evaluation of ulcerative proctitis disease activity is proposed. Secondary endpoints which should be evaluated include endoscopic remission, histological remission, mucosal healing, histologic endoscopic mucosal improvement, disability, fecal incontinence, urgency, constipation, and health-related quality of life.CONCLUSION: In response to the need for guidance on the design of clinical trials in patients with ulcerative proctitis, the PROCTRIAL consensus provides recommendations on the definition and endpoints for ulcerative proctitis clinical trials.
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| 2. |
- Celentano, Valerio, et al.
(författare)
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Standardization of ileoanal J-pouch surgery technique: Quality assessment of minimally invasive ileoanal J-pouch surgery videos
- 2022
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Ingår i: Surgery. - : MOSBY-ELSEVIER. - 0039-6060 .- 1532-7361. ; 172:1, s. 53-59
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Tidskriftsartikel (refereegranskat)abstract
- Background: Ileal pouch anal anastomosis is a complex procedure associated with significant morbidity, with several complications after ileal pouch anal anastomosis surgery leading to pouch failure. The aim of the study is to evaluate the heterogeneity surrounding the technique of ileoanal J-pouch surgery by assessing the safety and quality of published online peer-reviewed surgical videos.Methods: Ileal pouch anal anastomosis videos published on peer-reviewed surgical journals and video channels were edited and anonymized to demonstrate specific steps of the surgical procedure: mobilization and division of the rectum, formation of the ileoanal J-pouch reservoir, anastomosis, and lengthening techniques. The anonymized videos were presented to a group of reviewers with expertise in ileal pouch anal anastomosis blinded to the names and affiliations of the surgeons performing the procedure. Primary outcome was the rate of interobserver variability in the assessment of specific technical steps of the ileal pouch anal anastomosis surgery procedure. Secondary outcome was the appropriateness of the use of surgical videos review as an assessment tool for ileal pouch anal anastomosis surgery, measured as rate of reviewers being unable to answer for poor video quality.Results: In total, 29 video fragments were distributed, and 13 assessors completed a 60-item survey, organized in 7 major domains. The survey completion rate was 93.4%. Out of a total 729 answers, in 23 (3.2%) the reviewers indicated they were unable to comment due to poor video image, and in 48 (6.5%) were unable to comment due to the particular step not being shown in the procedure. The proportion of assessors rating rectal mobilization technically appropriate ranged from 30.7% to 92.3% and from 7.7% to 69.2% for safety. The level of rectal division was considered appropriate in 0 to 53.8% of the videos, whereas the stapling technique used for rectal division was appropriate in 0 to 70% of the videos.Conclusion: Our study assessed published peer-reviewed videos on ileal pouch anal anastomosis surgery and reported heterogeneity in the safety of the demonstrated techniques. Blind assessment of published peer-reviewed ileal pouch anal anastomosis videos reported a high rate of unsafe or inappropriate technique for rectal mobilization and transection in the reviewed videos, with fair interobserver agreement among reviewers. There is a need for consensus on what is considered safe and appropriate in ileal pouch anal anastomosis surgery. Peer review of ileal pouch anal anastomosis surgery videos could facilitate training and accreditation in this complex procedure.(c) 2021 Elsevier Inc. All rights reserved.
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