Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy (PREBIOUS)

August 3, 2014 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

488

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Manuel Lopez-Cano, MD, PhD
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar, Parc de Salut Mar
        • Contact:
        • Sub-Investigator:
          • Jose Antonio Pereira, MD, PhD
      • Lerida, Spain, 25198
        • Recruiting
        • Hospital Arnau de Vilanova
        • Contact:
        • Sub-Investigator:
          • Rafael Villalobos, MD
    • Barcelona
      • Igualada, Barcelona, Spain, 08700
        • Recruiting
        • Hospital de Igualada
        • Contact:
        • Sub-Investigator:
          • Xavier Feliú, MD, PhD
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Parc Tauli
        • Contact:
        • Sub-Investigator:
          • Salvador Navarro, MD,PhD
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Recruiting
        • Hospital de Sagunto
        • Contact:
        • Sub-Investigator:
          • Roberto Lozoya, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 years or older,
  • Signed informed consent,
  • Patients undergoing elective or urgent open abdominal surgical procedures regardless of benign or malignant disease.

Exclusion Criteria:

  • Presence of primary or recurrent incisional hernia
  • Expected survival < 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Laparotomy closure will be done by continuous PDS suture following a SL:WL ratio of 4:1 only is used for midline laparotomy closure.
Radiation: Control CT

At the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest.

The radiologist is blinded to the patient's history and the technique used for midline fascial closure.

Other: Clinical Follow Up
The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
Experimental: Reinforcement with Absorbable Mesh
Closure of the midline laparotomy incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.
Radiation: Control CT

At the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest.

The radiologist is blinded to the patient's history and the technique used for midline fascial closure.

Other: Clinical Follow Up
The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
Procedure: Reinforcement with Absorbable Mesh
Other Names:
  • GORE® BIO-A® Tissue Reinforcement prosthesis
  • (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh.
  • LNE/G-MED (CE) 0459

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complications
Time Frame: 30 days
Secondary endpoints are perioperative complications, including wound infection, hematoma, eventration, pain, reoperation.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Manuel Lopez-Cano, MD, PhD, Hospital Universitari Vall d´Hebron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

August 3, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 3, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)220/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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