Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial

Martin Gaillard, Panagiotis Lainas, Hélène Agostini, Ibrahim Dagher, Hadrien Tranchart, Martin Gaillard, Panagiotis Lainas, Hélène Agostini, Ibrahim Dagher, Hadrien Tranchart

Abstract

Background: Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The basic principle is to create a narrow stomach along the lesser curvature, using a calibration bougie as a template to perform a vertical partial gastrectomy, resecting the greater curvature and fundus of the stomach. The most common postoperative complication is gastric leak from the staple line, observed in approximately 3% of cases, which can result in long and incapacitating treatment. The diametre of the bougie used to calibrate the remnant stomach could impact the rate of postoperative gastric leak, a higher diametre being correlated with a lower risk of leak, without lowering long-term weight loss. This is the first randomized trial to compare the outcomes of LSG regarding the use of two different bougie diametres on postoperative gastric leak and mid-term weight loss.

Methods: Bougie Sleeve Trial (BOUST) is a superiority single-blinded randomized national trial, involving 17 centres. Participants will be randomized into two groups. LSG will be performed using a 48-Fr diametre calibration bougie in the experimental group and a standard care (34 to 38-Fr diametre) calibration bougie in the control group. Both groups will take part in a 2-year postoperative follow-up to assess postoperative gastric leak rate and weight loss and quality of life evolution.

Discussion: This study protocol will allow the investigators to determine if the use of a larger calibration bougie during LSG is associated with lower postoperative gastric leak occurrence without impairing mid-term weight loss and quality of life. The results of this trial will provide important data on patient safety and promote best practice for LSG procedures.

Trial registration: ClinicalTrials.gov NCT02937649 . Registered on 18 October 2016.

Keywords: Bariatric surgery; Calibration; Gastrectomy; Obesity, Morbid; Postoperative complications; Surgical stapling; Weight loss.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Outline of the trial. LSG, laparoscopic sleeve gastrectomy; Fr, French
Fig. 2
Fig. 2
Experimental 48-Fr bougie and standard care 38-Fr bougie

References

    1. Schaaf C, Iannelli A, Gugenheim J. Etat actuel de la chirurgie bariatrique en France. E-mémoires de L’Académie Nation de Chir. 2015;14(2):104–107.
    1. English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surgery for obesity and related diseases. 2018;14(3):259–263. doi: 10.1016/j.soard.2017.12.013.
    1. Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg. 2013;257(2):231–237. doi: 10.1097/SLA.0b013e31826cc714.
    1. Gagner M, Deitel M, Erickson AL, Crosby RD. Survey on laparoscopic sleeve gastrectomy (LSG) at the Fourth International Consensus Summit on Sleeve Gastrectomy. Obesity Surg. 2013;23(12):2013–2017. doi: 10.1007/s11695-013-1040-x.
    1. Sánchez-Santos R, Masdevall C, Baltasar A, Martínez-Blázquez C, García Ruiz de Gordejuela A, Ponsi E, et al. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obesity Surg. 2009;19(9):1203–1210. doi: 10.1007/s11695-009-9892-9.
    1. Yuval JB, Mintz Y, Cohen MJ, Rivkind AI, Elazary R. The effects of bougie caliber on leaks and excess weight loss following laparoscopic sleeve gastrectomy. Is there an ideal bougie size? Obesity Surg. 2013;23(10):1685–1691. doi: 10.1007/s11695-013-1047-3.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Cendán JC, Abu-aouf D, Gabrielli A, Caruso LJ, Rout WR, Hocking MP, Layon AJ. Utilization of intensive care resources in bariatric surgery. Obesity Surg. 2005;15(9):1247–1251. doi: 10.1381/096089205774512681.
    1. Clapp B, Harper B, Dodoo C, Klingsporn W, Barrientes A, Cutshall M, Tyroch A Trends in revisional bariatric surgery using the MBSAQIP database 2015-2017. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2020;16(7):908-915, DOI: 10.1016/j.soard.2020.03.002.
    1. Gagnière J, Slim K, Launay-Savary MV, Raspado O, Flamein R, Chipponi J. Previous gastric banding increases morbidity and gastric leaks after laparoscopic sleeve gastrectomy for obesity. J Visceral Surg. 2011;148(3):e205–e209. doi: 10.1016/j.jviscsurg.2011.05.004.
    1. Aurora AR, Khaitan L, Saber AA. Sleeve gastrectomy and the risk of leak: a systematic analysis of 4,888 patients. Surg Endosc. 2012;26(6):1509–1515. doi: 10.1007/s00464-011-2085-3.
    1. Gaillard M, Tranchart H, Lainas P, Ferretti S, Perlemuter G, Dagher I. Single-port laparoscopic sleeve gastrectomy as a routine procedure in 1000 patients. Surgery for obesity and related diseases. 2016;12(7):1270–1277. doi: 10.1016/j.soard.2016.01.011.
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–213. doi: 10.1097/.
    1. Slim K, Bousquet J, Kwiatkowski F, Lescure G, Pezet D, Chipponi J. First validation of the French version of the Gastrointestinal Quality of Life Index (GIQLI) Gastroenterol Clin Biol. 1999;23(1):25–31.
    1. Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmülling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995;82(2):216–222. doi: 10.1002/bjs.1800820229.
    1. Obésité : Prise en charge chirurgicale chez l'adulte. . Haute Autorité de Santé. 2009 Jan.

Source: PubMed

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