Dataset Information

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

ABSTRACT:

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)

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-022-06456-w.

SUBMITTER: Slagter N

PROVIDER: S-EPMC9214974 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Project description:BackgroundTailoring the biliopancreatic limb length in one anastomosis gastric bypass is proposed as beneficial in retrospective studies, yet randomized trials are lacking. The aim of this double-blind, single-centre RCT was to ascertain whether tailoring biliopancreatic limb length based on total small bowel length (TSBL) results in superior outcomes after one anastomosis gastric bypass compared with a fixed 150 cm biliopancreatic limb length.MethodsEligible patients, meeting International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) criteria for metabolic bariatric surgery, scheduled for primary one anastomosis gastric bypass surgery, and willing to be randomized, underwent TSBL measurement during surgery. When TSBL measurement was feasible, patients were randomly assigned to a standard 150 cm biliopancreatic limb length or a tailored biliopancreatic limb based on TSBL: TSBL less than 500 cm, biliopancreatic limb 150 cm; TSBL 500-700 cm, biliopancreatic limb 180 cm; and TSBL greater than 700 cm, biliopancreatic limb 210 cm. The primary outcome was percentage total weight loss at 5 years.ResultsBetween September 2020 and August 2022, 212 patients were randomized into the standard biliopancreatic limb group (105 patients) or the tailored biliopancreatic limb group (107 patients). The mean(s.d.) TSBL was 657(128) cm (range 295-1020 cm). In the tailored group, 150, 180, and 210 cm biliopancreatic limb lengths were applied to 8.4%, 53.3%, and 38.3% of patients respectively. The mean(s.d.) 1-year percentage total weight loss was 32.8(6.9)% in the standard group and 33.1(6.2)% in the tailored group (P = 0.787). Nutritional deficiencies and short-term complications showed no significant differences.ConclusionTailoring biliopancreatic limb length based on TSBL is safe and feasible. One year after surgery, it is not superior to a standard biliopancreatic limb length of 150 cm in terms of percentage total weight loss.Registration numberDutch Trial Register, NL7945.

Project description:Although Roux-en-Y Gastric Bypass (RYGB) remains the most effective treatment for obesity and type 2 diabetes (T2D), many patients fail to achieve remission, or relapse. Increasing intestinal limb lengths of RYGB may improve outcomes, but the mechanistic basis for this remains unclear. We hypothesize biliopancreatic (BP) limb length modulates the antidiabetic effect of RYGB. Rats underwent RYGB with a 20-cm (RYGB-20cm) or 40-cm (RYGB-40cm) BP limb and were compared with control animals. After 2 and 4 wk, portal and systemic blood was sampled during intestinal glucose infusion. Portosystemic gradient was used to calculate intestinal glucose utilization (Gutil), absorption (Gabsorp), and hormone secretion. Intestinal morphology and gene expression were assessed. At 2 wk, Gabsorp progressively decreased with increasing BP limb length; this pattern persisted at 4 wk. Gutil increased ≈70% in both RYGB-20cm and -40cm groups at 2 wk. At 4 wk, Gutil progressively increased with limb length. Furthermore, Roux limb weight, and expression of hexokinase and preproglucagon, exhibited a similar progressive increase. At 4 wk, glucagon-like peptide-1 and -2 levels were higher after RYGB-40cm, with associated increased secretion. We conclude that BP limb length modulates multiple antidiabetic mechanisms, analogous to the dose-response relationship of a drug. Early postoperatively, a longer BP limb reduces Gabsorp. Later, Gutil, Roux limb hypertrophy, hormone secretion, and hormone levels are increased with longer BP limb. Sustained high incretin levels may prevent weight regain and T2D relapse. These data provide the basis for customizing BP limb length according to patient characteristics and desired metabolic effect. NEW & NOTEWORTHY Biliopancreatic limb length in gastric bypass modulates multiple antidiabetic mechanisms, analogous to the dose-response relationship of a drug. With a longer biliopancreatic limb, Roux limb hypertrophy, increased glucose utilization, reduced glucose absorption, and sustained high incretin levels may prevent weight regain and diabetes relapse.