Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy (GENINGHERNIA)
Recruitment status was Recruiting
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Purpose
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 repair anymore. Chronic significant post operative pain is a common, clinically relevant, poorly understood and poorly studied entity which is 3 to 5 times more common than hernia recurrence. As a subgroup to chronic significant post operative pain or as a separate entity, sexual dysfunction due to ejaculatory and genital pain after inguinal hernia repair may happen in approximately 2.5% of patients. Patient's preoperative psychological profile as well as pain exposure history is showed to be important in the development of chronic significant post operative pain. The objective of this study is to analyse chronic significant post operative pain and the functional outcome status of patients after laparoscopic repair compared to open repair.
Methods: A randomized controlled non-blinded clinical trial is designed to compare open inguinal hernia mesh repair with laparoscopic totally extraperitoneal repair on chronic significant post operative pain, pain related sexual function disorders, complications, health related quality of life outcomes, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 21 years, with reducible inguinal unilateral or bilateral primary hernia who are candidates for elective surgery and medically fit for general anesthesia.130 patients will be enrolled for each group to achieve an α-Level of 0.05 and a power of 80%. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in may 2009.
| Condition | Intervention | Phase |
|---|---|---|
|
Inguinal Hernia Laparoscopic Surgery Pain Sexual Dysfunction, Physiological |
Procedure: Laparoscopic totally extraperitoneal inguinal hernia repair Procedure: Open tension free inguinal hernia mesh repair |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chronic Significant Pain and Functional Outcome After Laparoscopic Versus Open Groin Hernia Mesh Repair: Design of a Randomized Controlled Clinical Trial |
- Chronic significant post operative pain [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]
- Pain related sexual function disorders [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]
- Health related quality of life [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]
- Neuroticism [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]
- Postoperative surgical and medical complications [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]
- Recurrence rate [ Time Frame: 730th postoperative day ] [ Designated as safety issue: No ]
- Overall cost analysis [ Time Frame: 730th postoperative day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 260 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Laparoscopic repair
|
Procedure: Laparoscopic totally extraperitoneal inguinal hernia repair
3 trocars procedure. Blunt camera dissection without use of balloon dissector. Anatomical, preformed, polyester mesh passed around spermatic cord structures. No fixation of mesh.
Other Names:
|
|
Active Comparator: 2
Open tension free inguinal hernia mesh repair
|
Procedure: Open tension free inguinal hernia mesh repair
Classical Lichtenstein repair. Polyester flat 14x8cm mesh
Other Name: Lichtenstein repair
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.)
Contacts and Locations| Contact: Ihsan Inan, M.D. | +41223723311 ext 6858149 | ihsan.inan@hcuge.ch |
| Switzerland | |
| Geneva University Hospital, Department of Surgery, Visceral Surgery Division | Recruiting |
| Geneva, Switzerland, 1211 | |
| Principal Investigator: Ihsan Inan, M.D. | |
| Study Chair: | Philippe Morel, Prof. | Geneva University Hospital, Departement of Surgery, Visceral Surgery Division |
| Study Director: | Ihsan INAN, M.D. | Geneva University Hospital, Departement of Surgery, Visceral Surgery Division |
More Information
No publications provided
| Responsible Party: | Ihsan INAN M.D. Chef de Clinique, Visceral Surgery Division, Department of Surgery, Geneva University Hospital |
| ClinicalTrials.gov Identifier: | NCT00625534 History of Changes |
| Other Study ID Numbers: | 05-122 |
| Study First Received: | February 19, 2008 |
| Last Updated: | April 10, 2008 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Geneva:
|
Hernia Laparoscopy Pain Sexual Quality |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Sexual Dysfunctions, Psychological Sexual Dysfunction, Physiological Pathological Conditions, Anatomical |
Hernia, Abdominal Sexual and Gender Disorders Mental Disorders Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013