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

NCT ID: NCT00568269

Last Updated: 2007-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1513 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Inguinal Hernia

Keywords

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Recurrence rate after inguinal hernia repair on primary inguinal herina.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lichtenstein

Group Type ACTIVE_COMPARATOR

Open repair

Intervention Type PROCEDURE

Open repair is according to the Lichtenstein technique

TEP

Group Type EXPERIMENTAL

Laparoscopic repair

Intervention Type PROCEDURE

The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair

Interventions

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Open repair

Open repair is according to the Lichtenstein technique

Intervention Type PROCEDURE

Laparoscopic repair

The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Stig and Ragna Gorthon Foundation

UNKNOWN

Sponsor Role collaborator

Tyco Healthcare Group

INDUSTRY

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Centre for Clinical Research

Principal Investigators

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Arne S Eklund, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Clinical Research

Locations

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Centre for Clinical Research, Central hospital, entrance 29

Västerås, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 16862612 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20186889 (View on PubMed)

Other Identifiers

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Ups 144-96

Identifier Type: -

Identifier Source: secondary_id

SMIL II

Identifier Type: -

Identifier Source: org_study_id