Randomized Prospective Study Comparing Two Hypoabsorption Techniques for the Treatment of Type III Obesity (Body Mass Index Between 45 - 49.9 Kg/m2): Single Anastomose Duodenal Switch (SADI-S) and Single Anastomose Gastric By-pass (OAGBP)

Consorci Sanitari Integral0 个研究点目标入组 96 人2023年7月

适应症Obesity, Morbid

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Obesity, Morbid
发起方: Consorci Sanitari Integral
入组人数: 96
主要终点: the percentage of total weight loss (%TWL) of the patients after surgery
状态: 尚未招募
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.

注册库

clinicaltrials.gov

开始日期

2023年7月

结束日期

2029年7月

最后更新

2年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Consorci Sanitari Integral

责任方

Sponsor

入排标准

入选标准

•Patients over 18 and under 65 who meet criteria for bariatric surgery.
•Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time
•Signature of the informed consent of the study
•Patients suitable for laparoscopic surgery

排除标准

•Previous bariatric surgery
•2-stage surgery
•Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery
•Other associated surgical procedures in the same intervention.
•Conversion to laparotomy

结局指标

主要结局

the percentage of total weight loss (%TWL) of the patients after surgery

时间窗: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery

次要结局

% of patients with gastroesophageal reflux (acid and bile) after surgery(1 year, 3 year, 5 year after SADI-S and OAGBP surgery)
Number of Participants with complications in the immediate postoperative period(up to day 90 post-intervention)
Number of patients with nutritional deficiencies(1 year, 3 years, 5 years after SADI-S and OAGBP surgery)
Number of deaths in the immediate postoperative period(up to day 90 post-intervention)
Ratio of patients with more than 3 loose stools per day(1 year, 3 years, 5 years after the surgery)
questionnaire of quality of life(1 year, 3 years, 5 years after SADI-S and OAGBP surgery)