Recurrence rate of hiatal hernia repair with biomesh compared to repair without mesh * a double blinded, randomized, controlled trial.

Withdrawn

• Conditions: diaphragmatic hernia; hiatal hernia; 10000073; 10017998

• Registration Number: NL-OMON36174
• Lead Sponsor: Atrium Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients diagnosed with a diaphragmatic hernia
Patients older than 18 years
Patients under 75 years
ASA 1, 2 and 3

Exclusion Criteria

Lack of informed consent
Recurrent diaphragmatic hernia
Previous upper abdominal surgery
Pregnancy
Immunocompromised patients
Use of steroids
ASA IV and higher

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Recurrence rate (anatomical) in both intervention and control group<br /><br>Percentage of mesh erosions in the intervention group<br /><br>Percentage of mesh wrap migrations<br /><br>Complaints of pain, reflux or dysphagia in both groups </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Operative time<br /><br>Length of hospital stay<br /><br>Mesh infections<br /><br>Wound infections<br /><br>Gastrointestinal quality of life index (GIQLI)</p><br>