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Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy (GENINGHERNIA)

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ClinicalTrials.gov Identifier: NCT00625534
Recruitment Status : Unknown
Verified April 2008 by University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : February 28, 2008
Last Update Posted : April 15, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment 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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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:
  • TEP
  • Laparoscopic hernia repair
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


Outcome Measures

Primary Outcome Measures :
  1. Chronic significant post operative pain [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ]

Secondary Outcome Measures :
  1. Pain related sexual function disorders [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ]
  2. Health related quality of life [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ]
  3. Neuroticism [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ]
  4. Postoperative surgical and medical complications [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ]
  5. Recurrence rate [ Time Frame: 730th postoperative day ]
  6. Overall cost analysis [ Time Frame: 730th postoperative day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625534


Contacts
Contact: Ihsan Inan, M.D. +41223723311 ext 6858149 ihsan.inan@hcuge.ch

Locations
Switzerland
Geneva University Hospital, Department of Surgery, Visceral Surgery Division Recruiting
Geneva, Switzerland, 1211
Principal Investigator: Ihsan Inan, M.D.         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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

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
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008

Keywords provided by University Hospital, Geneva:
Hernia
Laparoscopy
Pain
Sexual
Quality

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Sexual Dysfunction, Physiological
Pathological Conditions, Anatomical
Hernia, Abdominal
Genital Diseases, Male
Genital Diseases, Female