Evaluating the impact of anterior crural repair during sleeve gastrectomy on gastroesophageal reflux disease

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

This study is testing if fixing a part of the stomach during weight loss surgery can help prevent heartburn and acid reflux in people who are having the surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT04884074 on ClinicalTrials.gov

What this trial studies

This study aims to assess whether performing anterior crural repair during laparoscopic sleeve gastrectomy can reduce the incidence of gastroesophageal reflux disease (GERD) compared to standard sleeve gastrectomy without repair. Participants will be screened for secondary causes of obesity and assessed for obesity-related diseases before undergoing the procedure. The study will involve collecting baseline data and monitoring post-operative outcomes to determine the effectiveness of the intervention in preventing GERD symptoms.

Who should consider this trial

Good fit: Ideal candidates are individuals with a BMI over 30 or 35 kg/m2 with obesity-related comorbidities who have not undergone previous bariatric procedures.

Not a fit: Patients with pre-existing gastroesophageal reflux disease or those who have had prior upper gastrointestinal surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the occurrence of GERD in patients undergoing sleeve gastrectomy, improving their quality of life post-surgery.

How similar studies have performed: While the approach of anterior crural repair during sleeve gastrectomy is being evaluated, similar studies have shown promising results in reducing GERD symptoms post-surgery.

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

Where this trial is running

Hong Kong

• Chinese University of Hong Kong — Hong Kong, China (Recruiting)

Study contacts

• Study coordinator: Enders KW Ng, Professor

Conditions Obesity; Gastro Esophageal Reflux Disease; Laparoscopic Sleeve Gastrectomy; Anterior Crural Repair