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Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

Primary Purpose

Recurrent Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lichtenstein hernioplasty
Laparoscopic TEP
Sponsored by
North Karelia Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • recurrent inguinal hernia
  • willing to participate

Exclusion Criteria:

  • unwilling to participate
  • bilateral hernia
  • preference towards either treatment arm

Sites / Locations

  • North Karelia Central Hospital - Clinic of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia.

Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia.

Outcomes

Primary Outcome Measures

further recurrence

Secondary Outcome Measures

chronic pain or discomfort

Full Information

First Posted
March 18, 2008
Last Updated
May 20, 2008
Sponsor
North Karelia Central Hospital
Collaborators
University of Kuopio Computing Center
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1. Study Identification

Unique Protocol Identification Number
NCT00642200
Brief Title
Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty
Official Title
Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
North Karelia Central Hospital
Collaborators
University of Kuopio Computing Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia.
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein hernioplasty
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic TEP
Primary Outcome Measure Information:
Title
further recurrence
Time Frame
3 weeks, 1 year, 2 years, 3 years
Secondary Outcome Measure Information:
Title
chronic pain or discomfort
Time Frame
3 weeks, 1 year, 2 years, 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: recurrent inguinal hernia willing to participate Exclusion Criteria: unwilling to participate bilateral hernia preference towards either treatment arm
Facility Information:
Facility Name
North Karelia Central Hospital - Clinic of Surgery
City
Joensuu
State/Province
North Karelia
ZIP/Postal Code
FI-80210
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19247022
Citation
Kouhia ST, Huttunen R, Silvasti SO, Heiskanen JT, Ahtola H, Uotila-Nieminen M, Kiviniemi VV, Hakala T. Lichtenstein hernioplasty versus totally extraperitoneal laparoscopic hernioplasty in treatment of recurrent inguinal hernia--a prospective randomized trial. Ann Surg. 2009 Mar;249(3):384-7. doi: 10.1097/SLA.0b013e318196d0b0.
Results Reference
derived

Learn more about this trial

Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

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