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

• Published in: Current controlled trials in cardiovascular medicine 2022-06, Vol.23 (1), p.526-526, Article 526
• Main Authors: Slagter, Nienke, de Heide, Loek J. M, Jutte, Ewoud H, Kaijser, Mirjam A, Damen, Stefan L, van Beek, André P, Emous, Marloes
• Format: Article
• Language: English
• Subjects: Anastomosis; Antihypertensives; Bariatric surgery; Biliopancreatic limb; Body mass index; Clinical trials; Complications and side effects; Diabetes; Evaluation; Gastric bypass; Gastrointestinal surgery; Hypertension; Informed consent; Laparoscopy; Obesity; One anastomosis gastric bypass; Patient outcomes; Quality of life; Registration; Remission (Medicine); Sleep apnea; Small intestine; Study Protocol; Surgeons; Surgical anastomosis; Tailoring limb length; Total small bowel length; Vitamins; Weight control
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06456-w

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) Keywords: Bariatric surgery, One anastomosis gastric bypass, Biliopancreatic limb, Tailoring limb length, Total small bowel length