A Prospective Study Comparing the Outcomes of Mini-Gastric Bypass and Duodenojejunal Bypass in Morbidly Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
This study aims to study and compare the efficacy in terms of weight loss and resolution of comorbidities of two bariatric surgery procedures namely Mini Gastric Bypass and Duodenojejunal Bypass in the North Indian population. This will help establish the efficacy of these procedures in North Indian population and guide surgeons in selecting procedure tailored for various comorbidities.
Primary Objective
To determine extent of weight loss in MGB and DJB in morbidly obese patients.
Secondary Objectives:
To determine resolution of type 2 DM, hypertension and dyslipidemia in 1 year follow up.
To determine patient mortality in 1 year follow up period.
To evaluate various complications of both the techniques in 1 year follow up.
To evaluate cost effectiveness of various techniques.
Criteria for resolution of comorbidities -
Hypertension -
complete resolution - normal recorded blood pressure without use of antihypertensive drugs
Partial resolution - decrease in BP from the baseline preoperative level but not to normal levels
- Diabetes mellitus -
complete remission - normal recorded HBA1C levels without use of anti-diabetic medications
Partial resolution - Decrease in HBA1C but not to normal levels.
- Dyslipidemia -
Resolution - normal recorded serum cholesterol levels.
no resolution - abnormal levels of serum cholesterol.
STATISTICAL ANALYSIS – Statistical analysis will be performed using statistical package for the social sciences (SPSS) version 21.0. For all analyses, P value less than 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI more than 37.5kg/m2 or BMI more than 32.5kg/m2 with associated co-morbidities (hypertension, diabetes mellitus, OSA) Patient who are willing to give complete written informed consent form acknowledging procedure and risks, awareness of the alternative treatments, risks involved .
- •Ability to return for scheduled follow up examinations for 3 years after bariatric surgery.
排除标准
- •Age less than 18 years.
- •Lack of informed consent.
- •Inability to ambulate .
- •Deep vein thrombosis .
- •General poor health .
- •In women with pregnancy or nursing or plans to become pregnant at same time during the course of treatment .
- •Addiction to smoking, alcohol or substance abuse.
- •Uncontrolled severe psychiatric illness.
结局指标
主要结局
Weight Loss
时间窗: Baseline, 3, 6 and 12 months
次要结局
- Resolution of DM(Baseline, 3, 6 and 12 months)
- Resolution of Hypertension(Baseline, 3, 6 and 12 months)
- Resolution of Dyslipidemia(Baseline, 3, 6 and 12 months)
研究者
Dr. Ayushya Gupta
GSVM MEDICAL COLLEGE, KANPUR