NCT01020058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

5.9 years

First QC Date

November 24, 2009

Last Update Submit

January 5, 2016

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

  • long-term post operative pain

    6 wks, 1 year

Secondary Outcomes (1)

  • cost-effectiveness of the separate procedures

    6wks, 1year

Study Arms (2)

Lichtenstein in local anesthesia (LLA)

ACTIVE COMPARATOR

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

Procedure: Mesh repair for primary inguinal hernia

TEP

ACTIVE COMPARATOR

Patient receives a totally extraperitoneal laparoscopic repair

Procedure: Mesh repair for primary inguinal hernia

Interventions

Mesh repair for primary inguinal herniaPROCEDURE

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

Also known as: Lichtenstein (LLA), TEP
Lichtenstein in local anesthesia (LLA)TEP

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Enköping Hospital

Enköping, 75436, Sweden

Location

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 26079901DERIVED

  • 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.

    PMID: 23572220DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Staffan Wollert, MD, PhD

    Uppsala University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

April 1, 2006

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

SE(2)