دورية أكاديمية

Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial.

التفاصيل البيبلوغرافية
العنوان: Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial.
المؤلفون: Slagter N; Center for Obesity Northern Netherlands (CON), Medical Center Leeuwarden, Henri Dunantweg 2, 8934, AD, Leeuwarden, The Netherlands. nienke.slagter@mcl.nl.; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. nienke.slagter@mcl.nl., de Heide LJM; Center for Obesity Northern Netherlands (CON), Medical Center Leeuwarden, Henri Dunantweg 2, 8934, AD, Leeuwarden, The Netherlands., Jutte EH; Center for Obesity Northern Netherlands (CON), Medical Center Leeuwarden, Henri Dunantweg 2, 8934, AD, Leeuwarden, The Netherlands., Kaijser MA; Center for Obesity Northern Netherlands (CON), Medical Center Leeuwarden, Henri Dunantweg 2, 8934, AD, Leeuwarden, The Netherlands., Damen SL; Center for Obesity Northern Netherlands (CON), Medical Center Leeuwarden, Henri Dunantweg 2, 8934, AD, Leeuwarden, The Netherlands., van Beek AP; Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands., Emous M; Center for Obesity Northern Netherlands (CON), Medical Center Leeuwarden, Henri Dunantweg 2, 8934, AD, Leeuwarden, The Netherlands.
المصدر: Trials [Trials] 2022 Jun 22; Vol. 23 (1), pp. 526. Date of Electronic Publication: 2022 Jun 22.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Gastric Bypass*/methods , Obesity, Morbid*/diagnosis , Obesity, Morbid*/surgery, Humans ; Quality of Life ; Randomized Controlled Trials as Topic ; Retrospective Studies ; Weight Loss
مستخلص: Background: The one anastomosis gastric bypass (OAGB) is being performed by an increasing number of bariatric centers over the world. However, the optimal length of the biliopancreatic (BP) limb remains a topic of discussion. Retrospective studies suggest the benefit of tailoring BP-limb length; however, randomized trials are lacking. The aim of this study is to investigate whether tailoring the length of the BP-limb based on total small bowel length (TSBL) leads to better results in terms of weight loss, vitamin deficiencies, and bowel movements compared to a fixed BP-limb length.
Methods: The TAILOR study is a double-blind single-center randomized controlled trial. Patients scheduled for primary OAGB surgery will be randomly allocated either to a standard BP-limb of 150 cm or to a BP-limb length based on their TSBL: TSBL < 500 cm, BP-limb 150 cm; TSBL 500-700 cm, BP-limb 180 cm; TSBL > 700 cm, BP-limb 210 cm. The primary outcome is to compare the percent total weight loss (%TWL) at 5 years between the two groups. Secondary outcomes include nutritional deficiencies, remission of comorbidities, symptoms of dumping, quality of life, and daily bowel movements. The study includes a total of 212 patients and is designed to detect a 5% difference in the primary endpoint.
Discussion: The TAILOR study will provide new insights into the effect of different BP-limb lengths and the role of the TSBL in the OAGB. The study is designed to provide guidance for bariatric surgeons to determine the optimal BP-limb length in the OAGB.
Trial Registration: Dutch Trial Register NL7945. Prospectively registered on 08 September 2019. NTR (trialregister.nl ).
(© 2022. The Author(s).)
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معلومات مُعتمدة: 2020-2 Research Fund Medical Center Leeuwarden
فهرسة مساهمة: Keywords: Bariatric surgery; Biliopancreatic limb; One anastomosis gastric bypass; Tailoring limb length; Total small bowel length
تواريخ الأحداث: Date Created: 20220622 Date Completed: 20220624 Latest Revision: 20220716
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC9214974
DOI: 10.1186/s13063-022-06456-w
PMID: 35733198
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-022-06456-w