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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00029401

Enrollment

300

Registered

2022-07-14

Start date

2022-12-28

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ventral W3 abdominal hernia K43

Interventions

Group 1: Closure of ventral W3 abdominal hernia by component separation Group 2: Closure of ventral W3 hernia by fascia traction

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
In this project, the two procedures (component separation as TAR versus fascia traction) will be compared in terms of effectiveness and complication rate.	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactMarius Helmedag

Uniklinik RWTH Aachen, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

mhelmedag@ukaachen.de0241/8037286

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026