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

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 an...

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Autores principales:	Martin Gaillard, Panagiotis Lainas, Hélène Agostini, Ibrahim Dagher, Hadrien Tranchart
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Bariatric surgery Obesity, Morbid Postoperative complications Gastrectomy Surgical stapling Calibration Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/0cc824513e17494983a6ccfc3078a7c2
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spelling	oai:doaj.org-article:0cc824513e17494983a6ccfc3078a7c22021-11-21T12:31:14ZImpact 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 trial10.1186/s13063-021-05734-31745-6215https://doaj.org/article/0cc824513e17494983a6ccfc3078a7c22021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05734-3https://doaj.org/toc/1745-6215Abstract 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 2016Martin GaillardPanagiotis LainasHélène AgostiniIbrahim DagherHadrien TranchartBMCarticleBariatric surgeryObesity, MorbidPostoperative complicationsGastrectomySurgical staplingCalibrationMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Bariatric surgery Obesity, Morbid Postoperative complications Gastrectomy Surgical stapling Calibration Medicine (General) R5-920
spellingShingle	Bariatric surgery Obesity, Morbid Postoperative complications Gastrectomy Surgical stapling Calibration Medicine (General) R5-920 Martin Gaillard Panagiotis Lainas Hélène Agostini Ibrahim Dagher Hadrien Tranchart 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
description	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
format	article
author	Martin Gaillard Panagiotis Lainas Hélène Agostini Ibrahim Dagher Hadrien Tranchart
author_facet	Martin Gaillard Panagiotis Lainas Hélène Agostini Ibrahim Dagher Hadrien Tranchart
author_sort	Martin Gaillard
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/0cc824513e17494983a6ccfc3078a7c2
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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

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