Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy - A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic GERD
研究概览
简要总结
The purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease.
详细描述
Introduction Obesity is a global pandemic. The prevalence of overweight and obesity is increasing globally. Together with its co-morbidities, obesity substantially decreased quality of life and life expectancy. Bariatric surgery has been shown to provide substantial and sustained effects on weight loss and ameliorates obesity-related comorbidities. Among different bariatric procedures, laparoscopic sleeve gastrectomy (LSG) is increasingly being performed due to the favorable bariatric outcome, simplicity of the procedure and relatively low complication profile as compared to bypass procedure.
Development of gastroesophageal reflux disease (GERD is a major health concern after LSG. It has been observed in the bariatric surgical community that many patients are complaining of persisted GERD symptoms after LSG surgery.
Aiming to avoid post-operative GERD, hiatal dissection with crural repair had been suggested to be performed on top of the sleeve gastrectomy procedure.
Data Collection Baseline data collection: All potential candidates will be screened for secondary causes of obesity, such as hypothyroidism and Cushing's syndrome, and are assessed for severity of obesity-related diseases including hypertension, diabetes mellitus, obstructive sleep apnoea syndrome and hyperlipidaemia. Extensive counseling will be given and potential benefits and complications of treatments will be discussed with all participants at least 4 weeks prior to recruitment.
Procedure data: Operative time, blood loss and total hospital stay are captured prospectively. All peri-operative complications will be documented and graded according to the Clavien-Dindo Classification System to facilitate comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization is done by telephone call to the randomization centre where a dedicated research assistant without detailed knowledge of the recruited patient's background will open a sealed envelope containing a computer-generated random number which indicates the mode of intervention. Both the patients and clinical assessors (independent of the operating surgeons) are blind to the mode of intervention in the first one year of enrollment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject without previous bariatric procedure and meets IFSO Asia-Pacific Chapter Consensus of Metabolic & Bariatric surgery criteria:
- •i. BMI more than 35 kg/m2 with or without co-morbidities. ii. BMI more than 30 kg/m2 with obesity related co-morbidities.
- •Subject without evidence of gastroesophageal reflux disease i. Symptomatic - No gastroesophageal reflux symptom (GerdQ score no greater than 7) ii. Endoscopic - No esophagitis. No Hiatus Hernia (apparent separation distance between the squamocolumnar junction and the diaphragmatic impression greater than 2 cm) iii. Functional
- •High-resolution manometry
- •24-hour esophageal pH study
- •ASA Class I - III
- •Subject is willing to give consent and comply with evaluation and treatment scheduled
排除标准
- •Pre-existing GERD, evident symptomatically, endoscopically or upon functional testing
- •Presence of Hiatus hernia (>2cm) or esophagitis
- •Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
- •Underlying uncontrolled endocrine problem that lead to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc)
- •ASA grade IV & V
- •Mental or psychiatric disorder; Drug or alcohol addiction
- •Cirrhosis or portal hypertension
- •Pregnant or breast feeding
- •Any condition which precludes compliance with the study;
- •History or presence of pre-existing autoimmune connective tissue disease
- •Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
- •Active infection
- •Life expectancy less than 12 months
- •Special population, e.g. prisoner, mentally disabled, investigators' student or employees
结局指标
主要结局
Incidence of symptomatic GERD
时间窗: 1 year
Defined by GerdQ score \> 7
次要结局
未报告次要终点
研究者
Enders K.W. Ng
Professor
Chinese University of Hong Kong