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

Phase 4

• Conditions: Incisional Hernia

• Registration Number: NCT02208557
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-05-02
• Study Start: 2014-07
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-03
• Last Update Submitted: 2014-08-03
• Study First Posted: 2014-08-05
• Last Update Posted: 2014-08-05
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 488

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of incisional hernia	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).

Secondary Outcome Measures

Name	Time	Method
Perioperative complications	30 days	Secondary endpoints are perioperative complications, including wound infection, hematoma, eventration, pain, reoperation.

Trial Locations

Locations (6)

Hospital de Igualada; 🇪🇸 Igualada, Barcelona, Spain

Hospital Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de Sagunto; 🇪🇸 Sagunto, Valencia, Spain

Hospital del Mar, Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lerida, Spain