Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy
GENINGHERNIA
Chronic Significant Pain and Functional Outcome After Laparoscopic Versus Open Groin Hernia Mesh Repair: Design of a Randomized Controlled Clinical Trial
1 other identifier
interventional
260
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 15, 2008
April 1, 2008
3 years
February 19, 2008
April 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic significant post operative pain
preoperative, 10, 30, 90, 365 and 730 postoperative days
Secondary Outcomes (6)
Pain related sexual function disorders
preoperative, 10, 30, 90, 365 and 730 postoperative days
Health related quality of life
preoperative, 10, 30, 90, 365 and 730 postoperative days
Neuroticism
preoperative, 10, 30, 90, 365 and 730 postoperative days
Postoperative surgical and medical complications
preoperative, 10, 30, 90, 365 and 730 postoperative days
Recurrence rate
730th postoperative day
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALLaparoscopic repair
2
ACTIVE COMPARATOROpen tension free inguinal hernia mesh repair
Interventions
3 trocars procedure. Blunt camera dissection without use of balloon dissector. Anatomical, preformed, polyester mesh passed around spermatic cord structures. No fixation of mesh.
Classical Lichtenstein repair. Polyester flat 14x8cm mesh
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geneva University Hospital, Department of Surgery, Visceral Surgery Division
Geneva, 1211, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 19, 2008
First Posted
February 28, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
April 15, 2008
Record last verified: 2008-04