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

Hernia, Inguinal Clinical Trial

Official title:

Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020058
• Other study ID #: 2004:M-360
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: January 5, 2016
• Start date: April 2006
• Est. completion date: December 2012

Study information

• Verified date: January 2016
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

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

Locations

Country	Name	City	State
Sweden	Enköping Hospital	Enkoping
Sweden	Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University Hospital	Uppsala County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term post operative pain		6 wks, 1 year	Yes
Secondary	cost-effectiveness of the separate procedures		6wks, 1year	No