Mesh versus patch for hernia epigastrica and umbilical repair. A multicenter patient-blinded randomized trial.

Completed

• Conditions: buikwandbreuken; Umbilical and epigastric hernia

• Registration Number: NL-OMON39471
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 346

Inclusion Criteria

- single primary umbilical or epigastric hernia
- size less than 3 cm (2 fingers)

Exclusion Criteria

- age < 18 years
- not capable to understand and complete questionnaires

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is number of complications.<br /><br><br /><br>A complication is defined as unexpected event related to the operation field<br /><br>which necessitates a treatment within 3 months postoperatievly. Treatment can<br /><br>be initiated by primar as well as general physician. These includes<br /><br>- peroperative bleeding or other damage<br /><br>- prescribed medication such as antibiotics and analgesics after discharge<br /><br>other than paracetamol<br /><br>- re-intervention for haematoma, abccess drainage, exploration due to pain /<br /><br>early recurrence / intra-abdominal problems<br /><br>- woundcare at least the equivalent of rinsing once a day<br /><br>- hospital stay longer than expected or re-admission for observation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pre-operative<br /><br>Length, weigth, Verbal Descriptor Scale (VDS) pain at rest, during excercise,<br /><br>VDS cosmetics, intensity of daily activities/work<br /><br><br /><br>Per-operative<br /><br>Randomized device, incarceration, resection hernia sac, diameter hernia,<br /><br>enlargment hernia, closure of fascia, presence of adhesions, operation<br /><br>duration, VDS ease procedure, complications, reason for protocol deviations<br /><br><br /><br>Postoperative<br /><br>Complications, Verbal Descriptor Scale (VDS) pain at rest, during excercise,<br /><br>VDS cosmetics, recurrence,<br /><br><br /><br>Costs<br /><br>Post-hoc computing based on number of vistis, operation duration, device and<br /><br>complications related costs up to 2 years postoperatively.</p><br>