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Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Open repair
Laparoscopic repair
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Recurrence rate after inguinal hernia repair on primary inguinal herina.

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male
  • Age 30-70 years referred to hospital with a primary inguinal hernia.

Exclusion Criteria:

  • Recurrent hernia
  • Scrotal or bilateral hernia
  • Previous lower abdominal surgery
  • Unable to participate in follow up
  • ASA more than 3
  • Bleeding diathesis.

Sites / Locations

  • Centre for Clinical Research, Central hospital, entrance 29

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lichtenstein

TEP

Arm Description

Outcomes

Primary Outcome Measures

Recurrence rate

Secondary Outcome Measures

Operative complications, postoperative recovery and chronic pain at 5 years.

Full Information

First Posted
December 5, 2007
Last Updated
December 5, 2007
Sponsor
Uppsala University Hospital
Collaborators
Stig and Ragna Gorthon Foundation, Tyco Healthcare Group
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1. Study Identification

Unique Protocol Identification Number
NCT00568269
Brief Title
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
Official Title
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Uppsala University Hospital
Collaborators
Stig and Ragna Gorthon Foundation, Tyco Healthcare Group

4. Oversight

5. Study Description

Brief Summary
The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Recurrence rate after inguinal hernia repair on primary inguinal herina.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1513 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lichtenstein
Arm Type
Active Comparator
Arm Title
TEP
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Open repair
Intervention Description
Open repair is according to the Lichtenstein technique
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic repair
Intervention Description
The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair
Primary Outcome Measure Information:
Title
Recurrence rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Operative complications, postoperative recovery and chronic pain at 5 years.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male Age 30-70 years referred to hospital with a primary inguinal hernia. Exclusion Criteria: Recurrent hernia Scrotal or bilateral hernia Previous lower abdominal surgery Unable to participate in follow up ASA more than 3 Bleeding diathesis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne S Eklund, MD
Organizational Affiliation
Centre for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Clinical Research, Central hospital, entrance 29
City
Västerås
ZIP/Postal Code
721 89
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16862612
Citation
Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
Results Reference
result
PubMed Identifier
20186889
Citation
Eklund A, Montgomery A, Bergkvist L, Rudberg C; Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy (SMIL) study group. Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair. Br J Surg. 2010 Apr;97(4):600-8. doi: 10.1002/bjs.6904.
Results Reference
derived

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Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

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