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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Unknown; Phase 4

Conditions: Incisional Hernia

Treatments: Other: Clinical Follow Up; Procedure: Reinforcement with Absorbable Mesh; Radiation: Control CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02208557

PR(AG)220/2013

Details and patient eligibility

About

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.

Enrollment: 488 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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488 participants in 2 patient groups

Control

Active Comparator group

Description:

Laparotomy closure will be done by continuous PDS suture following a SL:WL ratio of 4:1 only is used for midline laparotomy closure.

Treatment:

Other: Clinical Follow Up

Radiation: Control CT

Reinforcement with Absorbable Mesh

Experimental group

Description:

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.

Treatment:

Other: Clinical Follow Up

Radiation: Control CT

Procedure: Reinforcement with Absorbable Mesh