Overview

This trial is active, not recruiting.

Condition incisional hernia
Treatment mesh implementation
Sponsor Kantonsspital Liestal
Start date March 2008
End date October 2013
Trial size 270 participants
Trial identifier NCT01003067, 364/07

Summary

Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
(Experimental)
mesh implementation
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.

Primary Outcomes

Measure
Risk reduction of incisional hernia after laparotomy
time frame: 8 Year

Secondary Outcomes

Measure
Feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.
time frame: 8 Years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Informed consent - Median Laparotomy Exclusion Criteria: - Bowel perforation - Pregnancy - Palliative surgery - Drug abuse - Age under 18 - Mental disability - Allergy to mesh components

Additional Information

Official title Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Kantonsspital Liestal.