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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

November 24, 2009
January 5, 2016
April 2006
March 2012   (final data collection date for primary outcome measure)
long-term post operative pain [ Time Frame: 6 wks, 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01020058 on ClinicalTrials.gov Archive Site
cost-effectiveness of the separate procedures [ Time Frame: 6wks, 1year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia
Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hernia, Inguinal
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: Lichtenstein in local anesthesia (LLA)
    Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein
    Intervention: Procedure: Mesh repair for primary inguinal hernia
  • Active Comparator: TEP
    Patient receives a totally extraperitoneal laparoscopic repair
    Intervention: Procedure: Mesh repair for primary inguinal hernia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
December 2012
March 2012   (final data collection date for primary outcome measure)

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)
Male
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01020058
2004:M-360
No
Not Provided
Not Provided
Ursula Dahlstrand, Uppsala University Hospital
Uppsala University Hospital
Uppsala County Council, Sweden
Study Director: Staffan Wollert, MD, PhD Uppsala University Hospital
Uppsala University Hospital
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP