Overview

This trial is active, not recruiting.

Condition ventral hernia
Treatments prophylactic mesh, no prophylactic mesh closure
Sponsor Henares University Hospital
Start date June 2009
End date September 2011
Trial size 112 participants
Trial identifier NCT01788826, HH01

Summary

The incidence of ventral hernias has remained inappropriately high. Any innovation in order to reduce this incidence would be simply cost-effective. Although there is still some concern about the use of mesh in clean-contaminated or contaminated surgery, based in our experimental studies, we plan to use a mesh in the primary closure of abdominal incision to prevent incisional hernias.

The investigators propose a clinical trial to assess a model to prevent the incisional hernia after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization is scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide polypropylene mesh is fixed covering the midline closure; in the control group a conventional closure with a running suture of long-term absorbable material with a suture/wound length ratio 4:1. The sample size was calculated with an estimated incidence of ventral hernia of 25% in the control group and 10% in the intervention group, 0,05 alfa and a 0,15 beta error. The main goal is the appearance of a ventral hernia after 24 months of follow-up. Other outcomes are wound complications and morbidity. Exclusion criteria are adult patients with a previous ventral hernia, estimated survival of less than 6 months or hemodynamic instability during surgery.

The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24 months and abdominal CT controls at 6,12, and 24 months. The study will be statistically evaluated with SPSS 18.0.

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 prevention
Arm
(Experimental)
Use of a prefascial polypropylene mesh when closing midline laparotomy
prophylactic mesh
Closure of midline laparotomy using a prophylactic mesh. The midline is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1. Then, a prefascial large-pore low-weight 5 cm wide polypropylene mesh (Optilene Mesh Elastic, B.Braun) is fixed covering the midline closure. The mesh is fixed in the prefascial plane with absorbable monofilament interrupted sutures, USP 2/0.
(Experimental)
In this arm the laparotomy of the patients are closed with a running absorbable suture without a mesh
no prophylactic mesh closure
Closure of midline laparotomy without mesh. The laparotomy is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1.

Primary Outcomes

Measure
Compare the incidence of ventral hernia between the 2 groups
time frame: 24 months

Secondary Outcomes

Measure
Incidence of superficial surgical site infection
time frame: 30 days
Incidence of deep surgical site infection
time frame: 30 days
Seroma
time frame: 30 days
Postoperative complications
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - More than 18 years old. - Patients operated with elective or emergency midline laparotomy with the diagnosis of colorectal cancer. - Written informed consent or oral consent with the present of two witnesses who do not participate as investigators in the trial Exclusion Criteria: - Dissemination of oncologic disease: all stage IV tumors with estimated survival less than 3 months. - Simultaneous participation in another trial with interference of intervention and outcome. - Withdrawn or missing written consent. - Mental condition rendering the subject incapable of understanding the nature, scope and consequences of the trial. - Previous ventral hernia

Additional Information

Official title Randomized Clinical Trial to Evaluate the Use of a Prophylactic Polypropylene Mesh To Reduce the Incidence of Ventral Hernias in Colorectal Surgery
Principal investigator Miguel Ángel García-Ureña, Professor
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Henares University Hospital.