Fascia traction versus component separation as TAR for the treatment of of complex ventral W3 hernias. A prospective, randomized, multicenter study.

Not Applicable

Recruiting

Conditions: ventral W3 abdominal hernia
K43
Ventral hernia

Registration Number: DRKS00029401

Lead Sponsor: niklinik RWTH Aachen, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. hernia with a width of 10-20 cm
2. indication for surgical treatment
3. age of majority
4. consent to participate in the study

Exclusion Criteria

1. lack of capacity to consent
2. persons who have been placed in an institution by order of the authorities or the court.
in an institution by order of the authorities or the court
3. persons who are in a relationship of dependence or employment
to the investigator
4. any other condition that, in the investigator's judgment, would militate against
the use of the investigational product
5. minority

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this project, the two procedures (component separation as TAR versus fascia traction) will be compared in terms of effectiveness and complication rate. <br>

Secondary Outcome Measures

Name	Time	Method
1. (if the primary endpoint is not reached) closure of the anterior fascial leaflet by adding the alternative method in each case.<br>2. operation time (cut-suture time)<br>3. distance of the fascia edges before measure<br>4. distance of the fascial edges after measure<br>5. bladder pressure on day 0 (1 hour postoperatively<br>Postoperative length of stay in the intensive care unit, post<br>6. operative length of stay in the hospital<br>7. degree of pain on the 3rd post-operative day (visual-analogue <br>scale, VAS)<br>8. complications (surgical/general)<br>9. re-operation<br><br>