Status:
UNKNOWN
Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy
Lead Sponsor:
University Hospital, Geneva
Conditions:
Inguinal Hernia
Laparoscopic Surgery
Eligibility:
MALE
21-70 years
Phase:
PHASE4
Brief Summary
Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion for hernia rep...
Detailed Description
Hernia repair is the most frequent elective operation performed in general surgery. Chronic pain or persistent neuralgia has been recognized as a complication after inguinal hernia repair but was repo...
Eligibility Criteria
Inclusion
- Informed consent
- Diagnosis of primary, unilateral or bilateral, reducible groin hernias
- Medically fit for general anesthesia
- Comprehension and use of French language
- Installed in the geographical region without foreseeable move for two years
Exclusion
- Female gender, recurrent hernia
- Ongoing chronic pain syndrome, other than hernia origin
- Coagulation disorders, prophylactic or therapeutic anticoagulation, un able to stop platelet antiaggregation therapy 10 days before surgery
- Previous pelvic surgical procedures contraindicating laparoscopic technique
- 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.)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00625534
Start Date
April 1 2008
End Date
April 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