Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
Obesity, Gastro Esophageal Reflux Disease
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Gastro Esophageal Reflux Disease, Laparoscopic Sleeve Gastrectomy, Anterior Crural Repair
Eligibility Criteria
Inclusion Criteria:
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
1. High-resolution manometry 2. 24-hour esophageal pH study 4. ASA Class I - III 5. Subject is willing to give consent and comply with evaluation and treatment scheduled
Exclusion Criteria:
- 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
Sites / Locations
- Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
The study group
The control group
The procedure done to this group is Sleeve Gastrectomy with Anterior Crural Repair (ACR)
The procedure done to this group is the Standard Sleeve Gastrectomy (SSG)