NCT00226161

Brief Summary

The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads to a lower incidence of chronic pain compared to open herniorrhaphy.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 28, 2013

Status Verified

September 1, 2005

Enrollment Period

8 years

First QC Date

September 22, 2005

Last Update Submit

January 25, 2013

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Chronic pain

Secondary Outcomes (1)

  • Recurrence of the hernia

Interventions

Inguinal herniorrhaphyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary inguinal hernia

You may not qualify if:

  • History of severe mental illness or chronic pain elsewhere

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgical Gastroenterology, Gentofte University Hospital,

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jacob Rosenberg, professor,dr.med,chief consul

    Gentofte University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 28, 2013

Record last verified: 2005-09

Locations

DK(1)