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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,658
- 试验地点
- 12
- 主要终点
- Postoperative gastric leak rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 70 years
- •Sleeve gastrectomy as a primary bariatric procedure
- •Body Mass Index (BMI) > 40 kg/m² or > 35 kg/m² associated with at least one comorbidity susceptible to improve after surgery (including arterial hypertension, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, incapacitating osteo-articular disorders, non alcoholic steatohepatitis)
- •Decision for intervention after multidisciplinary discussion
- •Written informed consent
排除标准
- •Previous upper abdominal surgery (cholecystectomy excepted)
- •ASA (American Society of Anesthesiologists) score > 3
- •Ongoing pregnancy or breast feeding
- •Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures)
- •Coagulation disorder
- •Patient not covered by social security service and patient on AME
- •Patient under legal guardianship and trusteeship
- •Patient with known silicon allergy (calibration bougie contains medical silicon)
- •More generally, all other contraindications to the use of esophageal bougie MID-TUBE that have been the subject of a scientific paper or have been identified by the practitioner or practitioners
研究组 & 干预措施
Laparoscopic sleeve gastrectomy using 48-Fr bougie
Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie
干预措施: Laparoscopic sleeve gastrectomy using 48-Fr bougie (Procedure)
Laparoscopic sleeve gastrectomy using standard care bougie
Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr)
干预措施: Laparoscopic sleeve gastrectomy using standard care bougie (Procedure)
结局指标
主要结局
Postoperative gastric leak rate
时间窗: 30 days following the procedure
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
次要结局
- Postoperative morbidity rate(90 days following the procedure)
- Short-term weight loss(At 3 and 6 months after the procedure)
- Mid-term weight loss(At 1 and 2 years after the procedure)
- Quality of life related to health(At 3 months, 6 months, 1 year and 2 years after the procedure)