Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy
NCT ID: NCT02208557
Last Updated: 2014-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
488 participants
INTERVENTIONAL
2014-07-31
2015-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
Laparotomy closure will be done by continuous PDS suture following a SL:WL ratio of 4:1 only is used for midline laparotomy closure.
Control CT
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.
Clinical Follow Up
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.
Reinforcement with Absorbable Mesh
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.
Reinforcement with Absorbable Mesh
Control CT
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.
Clinical Follow Up
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.
Interventions
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Reinforcement with Absorbable Mesh
Control CT
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.
Clinical Follow Up
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent,
* Patients undergoing elective or urgent open abdominal surgical procedures regardless of benign or malignant disease.
Exclusion Criteria
* Expected survival \< 12 months.
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Manuel Lopez-Cano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Vall d´Hebrón
Locations
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Hospital del Mar, Parc de Salut Mar
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital de Igualada
Igualada, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
Hospital Arnau de Vilanova
Lleida, Lerida, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR(AG)220/2013
Identifier Type: -
Identifier Source: org_study_id
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