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

NCT02208557 | Unknown Phase 4

• 1 other identifier: PR(AG)220/2013
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 6

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.

Conditions

Incisional Hernia

Keywords

Incisional hernia; prevention; laparotomy closure; absorbable mesh

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia

  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 Outcomes (1)

• Perioperative complications

  30 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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; Other: Clinical Follow Up

Reinforcement with Absorbable Mesh

EXPERIMENTAL

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.

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

Interventions

Reinforcement with Absorbable Mesh PROCEDURE

Also known as: GORE® BIO-A® Tissue Reinforcement prosthesis, (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh., LNE/G-MED (CE) 0459

Reinforcement with Absorbable Mesh

Control CT RADIATION

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.

Control; Reinforcement with Absorbable Mesh

Clinical Follow Up OTHER

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.

Control; Reinforcement with Absorbable Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (6)

Hospital del Mar, Parc de Salut Mar

Barcelona, Barcelona, 08003, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital de Igualada

Igualada, Barcelona, 08700, Spain

RECRUITING

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Arnau de Vilanova

Lleida, Lerida, 25198, Spain

RECRUITING

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Manuel Lopez-Cano, MD, PhD

  Hospital Universitari Vall d´Hebrón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Lopez-Cano, MD, PhD

CONTACT

+34 - 932746000; mlpezcano@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: August 5, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

ES (6)