Randomized Controlled Trial of Laparoscopic Primary Crural Repair versus Primary Repair with Circular Bio-absorbable Hiatal Mesh Reinforcement in Hiatal Hernia Repair
- Conditions
- Adults with giant hiatal hernia`s.
- Registration Number
- NL-OMON27270
- Lead Sponsor
- Isala, Zwolle, the Netherlands.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
Age > 18 years
- Hiatus hernia type II-IV
Exclusion Criteria
- Age < 18 years
- Hiatus hernia type I.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiologic recurrence rate (CT-scan) of hiatal hernia.
- Secondary Outcome Measures
Name Time Method -Development of post-operative dysphagia. <br /><br>-Overall satisfaction with surgical outcome. <br /><br>-Major complications <br /><br>„XPostoperative hemorrhage with necessity for reoperation<br /><br>„XOrgan perforation (stomach, esophagus, small intestine, colon)<br /><br>„XMajor hemorrhage (>500cc) during operation <br /><br>„XLung or cardiac injury during operation<br /><br>-Minor complications <br /><br>„XSurgical site infection<br /><br>„XMinor bleeding (<500cc) during operation <br /><br>„XPostoperative pneumonia<br /><br>„XPostoperative urinary tract infection<br /><br>„XPostoperative deep venous thrombosis<br />