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

This study has been completed.

Sponsor:

Collaborators:

Stig and Ragna Gorthon Foundation

Tyco Healthcare Group

Information provided by:

Uppsala University Hospital

ClinicalTrials.gov Identifier:

NCT00568269

First received: December 5, 2007

Last updated: NA

Last verified: December 2007

History: No changes posted

Purpose

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

Condition	Intervention
Inguinal Hernia	Procedure: Open repair Procedure: Laparoscopic repair

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

Resource links provided by NLM:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:

Recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Operative complications, postoperative recovery and chronic pain at 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	1513
Study Start Date:	November 1996
Study Completion Date:	December 2007

Arms	Assigned Interventions
Active Comparator: Lichtenstein	Procedure: Open repair Open repair is according to the Lichtenstein technique
Experimental: TEP	Procedure: Laparoscopic repair The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568269

Locations

Sweden
Centre for Clinical Research, Central hospital, entrance 29
Västerås, Sweden, 721 89

Sponsors and Collaborators

Uppsala University Hospital

Stig and Ragna Gorthon Foundation

Tyco Healthcare Group

Investigators

Principal Investigator:

Arne S Eklund, MD

Centre for Clinical Research

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Arne Eklund, MD, Centre for Clinical Research
ClinicalTrials.gov Identifier:	NCT00568269 History of Changes
Other Study ID Numbers:	SMIL II, Ups 144-96
Study First Received:	December 5, 2007
Last Updated:	December 5, 2007
Health Authority:	Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University Hospital:

Recurrence rate after inguinal hernia repair on primary inguinal herina.

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 19, 2013

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