Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
Phase 1
Completed
- Conditions
- Incisional Hernia
- Interventions
- Device: Implant of a prosthetic mesh
- Registration Number
- NCT00891254
- Lead Sponsor
- Cirujanos la Serena
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. Intraperitoneal repair Implant of a prosthetic mesh Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery 2. On-Lay repair Implant of a prosthetic mesh Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery
- Primary Outcome Measures
Name Time Method Long-term recurrence 5 years
- Secondary Outcome Measures
Name Time Method Short-term complications 1 year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the long-term recurrence rates comparing intraperitoneal and on-lay mesh repair for incisional hernias in NCT00891254?
How does intraperitoneal mesh placement affect peritoneal adhesion and inflammation compared to on-lay techniques in hernia repair?
Which biomarkers correlate with successful tissue integration of intraperitoneal versus on-lay prosthetic meshes in incisional hernia patients?
What adverse event profiles distinguish intraperitoneal from on-lay mesh repairs in long-term incisional hernia clinical trials?
How do intraperitoneal mesh strategies compare to subfascial/retromuscular approaches in terms of chronic pain outcomes for incisional hernia repair?
Trial Locations
- Locations (1)
Hospital de La Serena
🇨🇱La Serena, Iv Region, Chile