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Chronic Pain After Inguinal Herniorrhaphy

Primary Purpose

Inguinal Hernia

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Inguinal herniorrhaphy
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)Male

Inclusion Criteria: Primary inguinal hernia Exclusion Criteria: History of severe mental illness or chronic pain elsewhere

Sites / Locations

  • Department of Surgical Gastroenterology, Gentofte University Hospital,

Outcomes

Primary Outcome Measures

Chronic pain

Secondary Outcome Measures

Recurrence of the hernia

Full Information

First Posted
September 22, 2005
Last Updated
January 25, 2013
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00226161
Brief Title
Chronic Pain After Inguinal Herniorrhaphy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2013 (undefined)
Study Completion Date
September 2013 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Inguinal herniorrhaphy
Primary Outcome Measure Information:
Title
Chronic pain
Secondary Outcome Measure Information:
Title
Recurrence of the hernia

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria: Primary inguinal hernia Exclusion Criteria: History of severe mental illness or chronic pain elsewhere
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, professor,dr.med,chief consul
Organizational Affiliation
Gentofte University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Surgical Gastroenterology, Gentofte University Hospital,
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Chronic Pain After Inguinal Herniorrhaphy

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