Status:
UNKNOWN
Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair
Lead Sponsor:
University Hospital, Geneva
Conditions:
Hernia, Ventral
Body Image
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%)...
Detailed Description
Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Discomfort, pain, body image alteration and diminished quality of life influences functional well being. Alteration in...
Eligibility Criteria
Inclusion
- Informed consent
- Age 18 years or older
- Diagnosis of reducible incisional hernias up to 200 cm²
- Medically fit for general anesthesia
- Comprehension and use of French language
- Installed in the geographical region without foreseeable move for two years
Exclusion
- Incarcerated hernia
- Ongoing chronic pain syndrome, other than hernia origin
- Coagulation disorders, prophylactic or therapeutic anticoagulation, unable to stop platelet antiaggregation therapy 10 days before surgery
- American Society of Anesthesiology Class 4 and 5 patients
- Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation
- Mentally ill patients
- Presence of local or systemic infection
- Life expectancy \< 2 years
- Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)
- Morbid obesity (BMI over 40)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00625053
Start Date
April 1 2008
End Date
September 1 2011
Last Update
April 15 2008
Active Locations (1)
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1
Geneva University Hospital, Department of Surgery, Visceral Surgery Division
Geneva, Switzerland, 1211