Clinical Trial: Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: PREBIOUS Trial : A Multicenter Randomized Controlled Trial of Preventive Midline Laparotomy Closure With a Bioabsorbable Mesh for the Prevention of Incisional Hernia.

Brief Summary:

Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which was to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure.

Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months.

Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.


Detailed Summary:
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: Incidence of incisional hernia [ Time Frame: 6 months ]

The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 6 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).


Original Primary Outcome: Same as current

Current Secondary Outcome: Perioperative complications [ Time Frame: 30 days ]

Secondary endpoints are perioperative complications, including wound infection, hematoma, eventration, pain, reoperation.


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: May 2, 2014
Date Started: July 2014
Date Completion: July 2015
Last Updated: August 3, 2014
Last Verified: August 2014