Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
Primary Purpose
Postoperative Complications, Hernia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Prosthetic repair of abdominal incisional hernia
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications focused on measuring Postoperative Complications, Drainage, Infection, Seroma, Hematoma, Recurrence, Abdominal Wall, Hernia, Surgical Mesh
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of midline abdominal wall incisional hernia
- Adults of 20 to 80 years old
- ASA I to III
- Inform consent signed by the patient and investigators
Exclusion Criteria:
- Incisional hernia less than 2 cm
- Groin hernia
- Antibiotic treatment before and during hospital admission
- Emergency admission for strangulated incisional hernia
- Immunosuppressing treatment
Sites / Locations
- Department of Visceral Surgery, University Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Drain
No drain
Arm Description
Outcomes
Primary Outcome Measures
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.
Secondary Outcome Measures
Full Information
NCT ID
NCT00478348
First Posted
May 22, 2007
Last Updated
November 14, 2017
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00478348
Brief Title
Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
Official Title
Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.
Detailed Description
Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.
Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.
Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.
In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.
The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Hernia
Keywords
Postoperative Complications, Drainage, Infection, Seroma, Hematoma, Recurrence, Abdominal Wall, Hernia, Surgical Mesh
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drain
Arm Type
Other
Arm Title
No drain
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Prosthetic repair of abdominal incisional hernia
Intervention Description
Rives-Stoppa repair of incisional hernia
Primary Outcome Measure Information:
Title
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of midline abdominal wall incisional hernia
Adults of 20 to 80 years old
ASA I to III
Inform consent signed by the patient and investigators
Exclusion Criteria:
Incisional hernia less than 2 cm
Groin hernia
Antibiotic treatment before and during hospital admission
Emergency admission for strangulated incisional hernia
Immunosuppressing treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Demartines, MD
Organizational Affiliation
Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Visceral Surgery, University Hospital Center
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
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