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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00625534
First received: February 19, 2008
Last updated: April 10, 2008
Last verified: April 2008
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Chronic significant post operative pain [ Time Frame: preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 July 24, 2014