Clinical trial NCT02208557: Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy
Official title: PREBIOUS Trial : A Multicenter Randomized Controlled Trial of Preventive Midline Laparotomy Closure With a Bioabsorbable Mesh for the Prevention of Incisional Hernia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Incisional Hernia
Keywords: Incisional hernia
prevention
laparotomy closure
absorbable mesh
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of incisional hernia
timeFrame: 6 months
Secondary outcomes:
measure: Perioperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Igualada
country: Spain
facility: Hospital de Igualada
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Barcelona
country: Spain
facility: Hospital del Mar, Parc de Salut Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Lerida
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Hospital Universitari Vall d´Hebrón
name: Manuel Lopez-Cano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: