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

Primary Purpose

Hernia, Inguinal

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Mesh repair for primary inguinal hernia

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Enköping Hospital
Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Lichtenstein in local anesthesia (LLA)

TEP

Arm Description

Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein

Patient receives a totally extraperitoneal laparoscopic repair

Outcomes

Primary Outcome Measures

long-term post operative pain

Secondary Outcome Measures

cost-effectiveness of the separate procedures

Full Information

NCT ID

NCT01020058

First Posted

November 24, 2009

Last Updated

January 5, 2016

Sponsor

Uppsala University Hospital

Collaborators

Uppsala County Council, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT01020058

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Uppsala University Hospital

Collaborators

Uppsala County Council, Sweden

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Inguinal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

384 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lichtenstein in local anesthesia (LLA)

Arm Type

Active Comparator

Arm Description

Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein

Arm Title

TEP

Arm Type

Active Comparator

Arm Description

Patient receives a totally extraperitoneal laparoscopic repair

Intervention Type

Procedure

Intervention Name(s)

Mesh repair for primary inguinal hernia

Other Intervention Name(s)

Lichtenstein (LLA), TEP

Intervention Description

Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh

Primary Outcome Measure Information:

Title

long-term post operative pain

Time Frame

6 wks, 1 year

Secondary Outcome Measure Information:

Title

cost-effectiveness of the separate procedures

Time Frame

6wks, 1year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Staffan Wollert, MD, PhD

Organizational Affiliation

Uppsala University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Enköping Hospital

City

Enkoping

ZIP/Postal Code

75436

Country

Sweden

Facility Name

Uppsala University Hospital

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

26079901

Citation

Westin L, Wollert S, Ljungdahl M, Sandblom G, Gunnarsson U, Dahlstrand U. Less Pain 1 Year After Total Extra-peritoneal Repair Compared With Lichtenstein Using Local Anesthesia: Data From a Randomized Controlled Clinical Trial. Ann Surg. 2016 Feb;263(2):240-3. doi: 10.1097/SLA.0000000000001289.

Results Reference

derived

PubMed Identifier

23572220

Citation

Dahlstrand U, Sandblom G, Ljungdahl M, Wollert S, Gunnarsson U. TEP under general anesthesia is superior to Lichtenstein under local anesthesia in terms of pain 6 weeks after surgery: results from a randomized clinical trial. Surg Endosc. 2013 Oct;27(10):3632-8. doi: 10.1007/s00464-013-2936-1. Epub 2013 Apr 10.

Results Reference

derived

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

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