Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02208557
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact	Manuel Lopez-Cano, MD, PhD
Phone	+34 - 932746000
Email	mlpezcano@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	July 2014
Completion date	July 2015

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See also
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Recruiting	`NCT05734222` - Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias	N/A
Enrolling by invitation	`NCT03105895` - Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI	N/A
Completed	`NCT02089958` - Standardization of Laparoscopic Hernia Repair	N/A
Completed	`NCT01961687` - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.	N/A
Completed	`NCT00998907` - PDS*Plus and Wound Infections After Laparotomy	N/A
Terminated	`NCT00498810` - COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)	N/A
Completed	`NCT04961346` - RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair	N/A
Terminated	`NCT03912662` - ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention	N/A
Recruiting	`NCT05620121` - ACute Treatment of Incisional Ventral Hernia
Recruiting	`NCT03561727` - Risk Factors for Development of Incisional Hernia in Transverse Incisions	N/A
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Recruiting	`NCT02277262` - PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)	Phase 4
Active, not recruiting	`NCT02328352` - "BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation"	Phase 1/Phase 2
Suspended	`NCT01520168` - Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management	N/A
Completed	`NCT05579652` - Change in Fascial Tension in Open Abdomens
Active, not recruiting	`NCT03390764` - Hernia After Colorectal Cancer Surgery	N/A
Completed	`NCT02321059` - Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms