PRIME-TRIAL: Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia
Completed
- Conditions
- hiatus herniaprotrusion of the upper part of the stomach10017943
- Registration Number
- NL-OMON39875
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
- Age >= 18 years
- Hiatus hernia
- Laparoscopic surgical repair clinically indicated
- Fit for surgery
- Suitable for any both procedure
Exclusion Criteria
- Age < 18 years
- No informed consent
- Previous anti-reflux surgery or repair for hiatus hernia
- Pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Integrity of the hiatal repair is the main endpoint. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives include clinical recurrence of the hernia, development of<br /><br>post-operative reflux disease, postoperative side effects, operation time,<br /><br>hospital admission and overall satisfaction with surgical outcome</p><br>