- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00891254
Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair
The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair.
The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Iv Region
-
La Serena, Iv Region, Chile, IV REGION
- Hospital de La Serena
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
- First repair
- Older than 35 years of age and younger than 75 years of age
- Both genders
- Any BMI
- Only upper abdominal midline incisional hernias (supraumbilical)
- Patients submitted only to elective repair
Exclusion Criteria:
- Recurrent incisional hernia
- Emergency surgery
- Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
- Lower midline abdominal incisional hernias
- Other hernias rather than midline incisional hernias
- Non-incisional hernias
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1. Intraperitoneal repair
Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery
|
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
|
Active Comparator: 2. On-Lay repair
Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery
|
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Long-term recurrence
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Short-term complications
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MARCELO A BELTRAN, M.D., Hospital de La Serena
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLS-2904009-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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