NCT00642200

Brief Summary

The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 1997

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

5.1 years

First QC Date

March 18, 2008

Last Update Submit

May 20, 2008

Conditions

Recurrent Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • further recurrence

    3 weeks, 1 year, 2 years, 3 years

Secondary Outcomes (1)

  • chronic pain or discomfort

    3 weeks, 1 year, 2 years, 3 years

Study Arms (2)

1

ACTIVE COMPARATOR

Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia.

Procedure: Lichtenstein hernioplasty

2

ACTIVE COMPARATOR

Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia.

Procedure: Laparoscopic TEP

Interventions

Lichtenstein hernioplastyPROCEDURE
1
Laparoscopic TEPPROCEDURE
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recurrent inguinal hernia
  • willing to participate

You may not qualify if:

  • unwilling to participate
  • bilateral hernia
  • preference towards either treatment arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Karelia Central Hospital - Clinic of Surgery

Joensuu, Pohjois-Karjala, FI-80210, Finland

Location

Related Publications (1)

  • Kouhia ST, Huttunen R, Silvasti SO, Heiskanen JT, Ahtola H, Uotila-Nieminen M, Kiviniemi VV, Hakala T. Lichtenstein hernioplasty versus totally extraperitoneal laparoscopic hernioplasty in treatment of recurrent inguinal hernia--a prospective randomized trial. Ann Surg. 2009 Mar;249(3):384-7. doi: 10.1097/SLA.0b013e318196d0b0.

    PMID: 19247022DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

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

March 18, 2008

First Posted

March 24, 2008

Study Start

January 1, 1997

Primary Completion

February 1, 2002

Study Completion

April 1, 2007

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

FI(1)