Sleeve Gastrectomy and the Influence of Concomitant Hiatal Hernia Repair

Withdrawn

• Conditions: excess stomach acid; GERD; 10017998

• Registration Number: NL-OMON42404
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Age 18-65 years
- Body Mass Index (BMI) of *40 or *35 with significant comorbidity, with an indication for LSG
- Fit for surgery

Exclusion Criteria

- Age <18 and >65 years
- No informed consent
- History of GERD, reflux esophagitis or Barrett*s esophagus
- History of, or intraoperatively diagnosed, paraesophageal hernia (type II) or mixed (type III), or hiatal hernia > 5,0 cm
- Previous anti-reflux surgery, HH repair or previous bariatric surgery
- Pregnant
- Severe esophageal motility disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the differences in total esophageal acid exposure between<br /><br>patients (diagnosed with small HH) who underwent either LSG alone or LSG+HHR. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints consist of 1) changes in prevalence and intensity of GERD<br /><br>symptoms, dysphagia symptoms, and quality of life based on validated<br /><br>questionnaires between these two groups, 2) changes in belching, the number of<br /><br>acid and weakly acidic reflux episodes and manometric changes, 3) the effect of<br /><br>LSG on total esophageal acid exposure, weakly acid exposure and manometric<br /><br>changes in patients with no intraoperatively diagnosed HH who underwent LSG<br /><br>alone and (4) changes in anti-reflux medication usage in both groups of<br /><br>patients within the HH-group and patients in the no-HH-group. </p><br>