Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias
Phase 4
Completed
- Conditions
- Abdominal Hernia
- Interventions
- Procedure: abdominal wall reconstruction
- Registration Number
- NCT01018524
- Lead Sponsor
- Hungarian Surgical Society
- Brief Summary
The purpose of this study is to:
1. compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
2. find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.
- Detailed Description
To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
- During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
- All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
- For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.
Exclusion Criteria
- Ages fewer than 18 or above 70 years
- Hernia orifice under 5 cm2.
- Planned or accidental intraoperative opening of any bowel.
- Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
- Severe renal or hepatic failure
- Advanced stage of tumours or currently treated malignancies.
- Inflamed or muddy content of hernia sac.
- If the patient did not signed the consent form.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description large hernias - onlay mesh abdominal wall reconstruction - small hernias - suture repair abdominal wall reconstruction - small hernias - mesh repair abdominal wall reconstruction - large hernias - sublay mesh abdominal wall reconstruction -
- Primary Outcome Measures
Name Time Method recurrence rate after hernia surgery 5 years
- Secondary Outcome Measures
Name Time Method chronic pain after hernia surgery more one year complications after hernia surgery 0-5 years
Trial Locations
- Locations (1)
Dept. of Surgery Univ. of Pecs
🇭🇺Pecs, Hungary
Dept. of Surgery Univ. of Pecs🇭🇺Pecs, Hungary