Prevention of parastomal hernia with a prosthetic mesh in a laparoscopic constructed end-colostomy .

Prevention of a parastomal hernia after laparoscopic construction of an end-colostomy by reinforcing the abdominal wall with a polypropylene mesh. The Prevent II trial: A multicenter randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22459

Enrollment

150

Registered

2014-07-20

Start date

2014-09-09

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Parastomal hernia, Prophylactic, Prevention, Laparoscopic, Mesh, Colostomy

Interventions

The use of a monofilament polypropylene mesh (PPM) in a retromuscular position during laparoscopic creation of an end-colostomy.

Eligibility

Inclusion criteria

Inclusion criteria: 1.Elective laparoscopic formation of a permanent end colostomy 2. Age between 18 and 85 years 3. Signed informed consent 4. Able to understand the study questionnaires

Exclusion criteria

Exclusion criteria: 1. Expected survival < 12 months 2. Stoma formation in an emergency setting 3. Previous surgery at the colostomy site 4. Formation of an ileostomy or a loop end ostomy 5. Correction of a previously constructed colostomy

Design outcomes

Primary

Measure	Time frame
The incidence of parastomal hernia.	—

Secondary

Measure	Time frame
Perioperative morbidity (stomal necrosis, stenosis, peristomal- or surgical wound infections), mortality, pain, Quality of life, and cost-effectiveness.	—

Contacts

Public ContactD. Faraj

d.faraj3@gmail.com0624893908

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)