Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients
研究概览
简要总结
The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics.
详细描述
This study will be a prospective, randomized controlled trial with a 1:1 recruitment allocation ratio. Patients will be randomized to Standard fixed-length RYGB (sRYGB) or ratio-adjusted limb lengths (aRYGB) once the total small bowel length (TSBL) is fully counted intraoperatively.
sRYGB will serve as the control group which will utilize BP and roux limb lengths of 100cm and 100cm, respectively. For the treatment group, aRYGB will incorporate a BP limb length measuring 30% and a roux limb of 15% of total small bowel length each.
Outcomes to be investigated:
Specific Aim 1: To determine significantly increased Total Weight Loss (TWL) after aRYGB compared to sRYGB in morbidly obese patients Given current understanding that weight loss after RYGB is mediated, at least in part, by a malabsorptive process, the investigators hypothesize that TWL will be greater after aRYGB versus sRYGB. As per standard of care at our institute, routine postoperative follow-up in the multidisciplinary Bariatric clinic will occur every 6 months (± 14 days) or more frequently as clinically indicated for the first two years postoperatively followed by yearly thereafter. Weight will be recorded in kilograms and a BMI will be calculated by the ratio of patient weight in kilograms over patient height in meters squared. Postoperative TWL will then be measured postoperatively at 6, 12, 24, 60 months from surgery.
Specific Aim 2: To compare rates of Diabetes Mellitus (DM) resolution between aRYGB Vs SRYGB by DM subgroup analysis Of the many metabolic changes that occur after bariatric surgery, one of the most salient effects include a rapid and effective resolution of DM. This has been extensively studied in context of various bariatric surgeries, including RYGB by our institution as previously described by the STAMPEDE trial. Significant reduction of HbA1C and improvement in insulin sensitivity was noted as early as six to 12 months postoperatively. As such, this study proposes measurement of the following two metrics at 6, 12, 24, 60 months postoperatively: 1) proportion of subjects achieving HbA1C less than or equal to 6.5%; and, 2) proportion of subjects able to wean and/or discontinue glycemic control medications.
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
- •morbidly obese patients (defined by BMI between 40 and 60).
- •Patient who understands and accepts the need for a long-term follow-up.
- •Patient who agrees to be included in the study
排除标准
- •individuals unable to understand and sign a written consent form
- •patients with history of previous bariatric surgery procedures
- •presence of a severe and evolutive life threatening pathology unrelated to obesity
- •previous gastric or small bowel resection
- •active cancer
- •pregnancy or desired to be pregnant during the study
- •mentally unbalanced patients under supervision or guardianship, patient unable to give consent
研究组 & 干预措施
aRYGB
BP and roux limb lengths measuring 30% and 15% respectively of patient's total small bowel length.
干预措施: Surgery (Procedure)
sRYGB
Standard fixed-length RYGB
干预措施: Surgery (Procedure)
结局指标
主要结局
To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients
时间窗: 6,12,24 and 60 months from surgery
Measured in kilograms
次要结局
- To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups.(6,12,24 and 60 months from surgery)
- To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis(6,12,24 and 60 months from surgery)
- To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity(6,12,24 and 60 months from surgery)
研究者
Salvador Navarrete
Principal Investigator
The Cleveland Clinic