Randomized Controlled Trial Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- GERD
研究概览
简要总结
The aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD.
详细描述
Laparoscopic Sleeve Gastrectomy (LSG) is now the most commonly performed bariatric surgery world wide. The results of LSG on outcomes of GERD are conflicting. It has been reported to increase the severity of pre existing GERD and also to cause new onset GERD in considerable number of patients.
In this study the effect of adding a novel procedure i.e. ligamentum teres cardiopexy,(LTC) to regular LSG on occurence of de Novo GERD will be investigated. de Novo GERD has been found to occur in 20% of cases post LSG.
This study is a randomized, prospective, parallel group, controlled trial to compare the effect of LSG versus LSG with LTC on occurence of de Novo GERD.
This is a single center based trial, being conducted in GEM hospital and research center, Coimbatore, Tamil Nadu, India. The trial has been approved by GEM research ethics committee.
Investigators are planning to enroll patients who are not having any objective or subjective evidence of GERD. The participants will be optimized as per institutional bariatric surgery protocol. After complete evaluation and optimization, participants will be randomized by computer generated random numbers into either LSG or LSG with LTC group.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •candidate for bariatric surgery according to IFSO - APC guidelines
- •No evidence (objective and subjective) of GERD
排除标准
- •Presence of GERD either by history or by 24 hr pH study
研究组 & 干预措施
LSG
This group will receive standard laparoscopic sleeve gastrectomy
干预措施: laparoscopic sleeve gastrectomy (Procedure)
LSG with LTC
This group will receive LSG along with the novel LTC procedure
干预措施: ligamentum teres cardiopexy with sleeve gastrectomy (Procedure)
结局指标
主要结局
GERD
时间窗: 6 months
Subjective (Gastroesophageal Reflux Disease questionnaires - GERD - Q) and objective (24 hour pH study) measurement of occurence of GERD will be done GERD - Q - Score 0-2 denotes no GERD. Score more than or equal to 3 indicates presence of GERD 24 hr pH study - Demeester score more than 14.7 is indicative of presence of GERD
次要结局
未报告次要终点