NCT00568269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,513

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 1996

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1996

Completed
11.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
Last Updated

December 6, 2007

Status Verified

December 1, 2007

First QC Date

December 5, 2007

Last Update Submit

December 5, 2007

Conditions

Inguinal Hernia

Keywords

Recurrence rate after inguinal hernia repair on primary inguinal herina.

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    5 years

Secondary Outcomes (1)

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

    5 years

Study Arms (2)

Lichtenstein

ACTIVE COMPARATOR
Procedure: Open repair

TEP

EXPERIMENTAL
Procedure: Laparoscopic repair

Interventions

Open repairPROCEDURE

Open repair is according to the Lichtenstein technique

Lichtenstein
Laparoscopic repairPROCEDURE

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

TEP

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Research, Central hospital, entrance 29

Västerås, 721 89, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 16862612RESULT

  • 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.

    PMID: 20186889DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Arne S Eklund, MD

    Centre for Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

November 1, 1996

Study Completion

December 1, 2007

Last Updated

December 6, 2007

Record last verified: 2007-12

Locations

SE(1)