Status:
UNKNOWN
Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Obesity
Gastro Esophageal Reflux Disease
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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.
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04884074
Start Date
May 1 2021
End Date
December 30 2025
Last Update
May 12 2021
Active Locations (1)
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1
Chinese University of Hong Kong
Hong Kong, China