Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia

This study has been completed.
Sponsor:
Collaborator:
Uppsala County Council, Sweden
Information provided by (Responsible Party):
Ursula Dahlstrand, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01020058
First received: November 24, 2009
Last updated: January 5, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.

Condition Intervention
Hernia, Inguinal
Procedure: Mesh repair for primary inguinal hernia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • long-term post operative pain [ Time Frame: 6 wks, 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cost-effectiveness of the separate procedures [ Time Frame: 6wks, 1year ] [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: April 2006
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lichtenstein in local anesthesia (LLA)
Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein
Procedure: Mesh repair for primary inguinal hernia
Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh
Other Names:
  • Lichtenstein (LLA)
  • TEP
Active Comparator: TEP
Patient receives a totally extraperitoneal laparoscopic repair
Procedure: Mesh repair for primary inguinal hernia
Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh
Other Names:
  • Lichtenstein (LLA)
  • TEP

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral inguinal hernia
  • suitable for open mesh repair in local anesthesia as well as laparoscopic repair
  • ASA score I-III
  • informed consent

Exclusion Criteria:

  • ASA score IV (not suitable for TEP)
  • bilateral hernias (laparoscopic repair preferable)
  • recurrent hernia (primary repair affects preferable treatment)
  • large scrotal hernias (not suitable for local anesthesia)
  • earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)
  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: NCT01020058

Locations
Sweden
Enköping Hospital
Enkoping, Sweden, 75436
Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University Hospital
Uppsala County Council, Sweden
Investigators
Study Director: Staffan Wollert, MD, PhD Uppsala University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ursula Dahlstrand, MD, PhD, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01020058     History of Changes
Other Study ID Numbers: 2004:M-360 
Study First Received: November 24, 2009
Last Updated: January 5, 2016
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016