Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

Launched by CHINESE UNIVERSITY OF HONG KONG · May 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a specific surgical technique called anterior crural repair, done during a weight-loss surgery called laparoscopic sleeve gastrectomy, can help reduce the chances of developing gastroesophageal reflux disease (GERD) in patients who have not had any previous weight-loss surgery. GERD is a condition where stomach acid frequently flows back into the esophagus, causing discomfort and other symptoms. The researchers want to see if this repair during surgery provides better results than not performing it.

To be eligible to participate, patients need to be between the ages of 18 and 75 and have a body mass index (BMI) of over 30 or 35, depending on whether they have other health issues related to obesity. Importantly, they should not have any signs of GERD before the surgery. Participants can expect to undergo the laparoscopic sleeve gastrectomy with or without the repair, and their progress will be monitored afterward. This trial is currently looking for participants, and it’s a great opportunity for those who meet the requirements and are looking for solutions to their obesity-related health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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.
• • 2. 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:
• • 1. Pre-existing GERD, evident symptomatically, endoscopically or upon functional testing
• • 2. Presence of Hiatus hernia (\>2cm) or esophagitis
• • 3. Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
• • 4. Underlying uncontrolled endocrine problem that lead to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc)
• • 5. ASA grade IV \& V
• • 6. Mental or psychiatric disorder; Drug or alcohol addiction
• • 7. Cirrhosis or portal hypertension
• • 8. Pregnant or breast feeding
• • 9. Any condition which precludes compliance with the study;
• • 10. History or presence of pre-existing autoimmune connective tissue disease
• • 11. Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
• • 12. Active infection
• • 13. Life expectancy less than 12 months
• • 14. Special population, e.g. prisoner, mentally disabled, investigators' student or employees