Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.
Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss. The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,658
After gastric mobilization, the 48-Fr bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
After gastric mobilization, the standard care bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
Hôpital Ambroise Paré
Boulogne-Billancourt, France
SUSPENDEDHôpital Côte de Nacre CHU de Caen
Caen, France
WITHDRAWNPostoperative gastric leak rate
Postoperative gastric leak rate during the first month following the procedure will be proven either on: * Morphologic examination (with contrast ingestion) * Blue dye test during surgical reintervention or postoperative course * Contrast opacification during endoscopy
Time frame: 30 days following the procedure
Postoperative morbidity rate
Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure.
Time frame: 90 days following the procedure
Short-term weight loss
Short-term weight loss will be assessed by calculation of excess weight loss at 3 and 6 months after the procedure.
Time frame: At 3 and 6 months after the procedure
Mid-term weight loss
Mid-term weight loss will be assessed by calculation of excess weight loss at 1 and 2 years after the procedure.
Time frame: At 1 and 2 years after the procedure
Quality of life related to health
Quality of life related to health will be assessed at 3 months, 6 months, 1 year and 2 years after the procedure with the validated GIQLI scale (Gastro Intestinal Quality of Life Index)
Time frame: At 3 months, 6 months, 1 year and 2 years after the procedure
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CHU Antoine Béclère
Clamart, France
Centre hospitalier Intercommunal de Créteil
Créteil, France
WITHDRAWNHôpital MICHALLON, CHU de Grenoble
La Tronche, France
WITHDRAWNHôpital Dupuytren - Limoges
Limoges, France
WITHDRAWNClinique de l'Yvette
Longjumeau, France
RECRUITINGService de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
Paris, France
RECRUITINGCHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
Poissy, France
RECRUITINGCH Saint-Denis
Saint-Denis, France
RECRUITING...and 2 more locations