Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

H

Henares University Hospital

Status

Unknown

Conditions

Ventral Hernia

Treatments

Procedure: Prophylactic mesh
Procedure: No prophylactic mesh closure

Study type

Interventional

Funder types

Other

Identifiers

NCT01788826
HH01

Details and patient eligibility

About

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.

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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  • Withdrawn or missing written consent.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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

Prophylactic Mesh
Experimental group
Description:
Use of a prefascial polypropylene mesh when closing midline laparotomy
Treatment:
Procedure: Prophylactic mesh
No prophylactic mesh closure
Experimental group
Description:
In this arm the laparotomy of the patients are closed with a running absorbable suture without a mesh
Treatment:
Procedure: No prophylactic mesh closure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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