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NCT00568269 Clinical Trial

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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00568269
Other study ID # SMIL II
Secondary ID Ups 144-96
Status Completed
Phase N/A
First received December 5, 2007
Last updated December 5, 2007
Start date November 1996
Est. completion date December 2007

Study information
Verified date December 2007
Source Uppsala University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1513
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 30 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Open repair
Open repair is according to the Lichtenstein technique
• Laparoscopic repair
The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair

Locations
Country Name City State
Sweden Centre for Clinical Research, Central hospital, entrance 29 Västerås

Sponsors (3)
Lead Sponsor Collaborator
Uppsala University Hospital Stig and Ragna Gorthon Foundation, Tyco Healthcare Group

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence rate 5 years Yes
Secondary Operative complications, postoperative recovery and chronic pain at 5 years. 5 years Yes
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