ArticleTrials2021
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.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02937649 (Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate
Who cites it
2 citing papers in PubMed, 6 citations in OpenAlex.
- Risk Factors and Management Approaches for Staple Line Leaks Following Sleeve Gastrectomy: A Single-Center Retrospective Study of 402 Patients.Journal of personalized medicine · 2023Article
- Differences in Technical Aspects of Primary Sleeve Gastrectomy Prior to Redo Bariatric Surgery-A Multicenter Cohort Study (PROSS Study).Medicina (Kaunas, Lithuania) · 2023Article
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
backgroundLaparoscopic 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.
methodsBougie 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 registrationClinicalTrials.gov NCT02937649 . Registered on 18 October 2016.
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