Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia.
- Conditions
- Hiatus Hernia
- Registration Number
- NL-OMON23150
- Lead Sponsor
- Antonius Ziekenhuis, Nieuwegein
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
1. Age ≥ 18 years;
2. Hiatus hernia;
Exclusion Criteria
1. Age < 18 years;
2. No informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Integrity of the hiatal repair is the main endpoint.
- Secondary Outcome Measures
Name Time Method Secondary objectives include clinical recurrence of the hernia, development of post-operative reflux disease, postoperative side effects and overall satisfaction with surgical outcome.