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Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair

Primary Purpose

Sexual Dysfunction, Hernia, Inguinal, Other Chronic Postoperative Pain

Status
Completed
Phase
Locations
Denmark
Study Type
Observational
Intervention
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Sexual Dysfunction focused on measuring Groin hernia, chronic pain, Persistent postoperative pain, Laparoscopic inguinal herniotomy, Sexual dysfunction

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients
  • >18 yrs

Exclusion Criteria:

  • Research protection

Sites / Locations

  • Section of Surgical Pathophysiology, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Pain patients

Non-pain patients

Arm Description

Patients with pain related sexual dysfunction after laparoscopic inguinal hernia repair

Patients with no pain related sexual dysfunction after laparoscopic inguinal hernia repair

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 11, 2010
Last Updated
October 29, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
Innovative Medicines Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT01086007
Brief Title
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair
Official Title
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair
Study Type
Observational

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Innovative Medicines Initiative

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Previous studies have reported that about 3 % of patients who have had open inguinal herniorrhaphy had a visceral, ejaculatory-related pain. The investigators want to assess this problem among patients after laparoscopic inguinal hernia repair with(self-administered questionnaire study).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Hernia, Inguinal, Other Chronic Postoperative Pain
Keywords
Groin hernia, chronic pain, Persistent postoperative pain, Laparoscopic inguinal herniotomy, Sexual dysfunction

7. Study Design

Enrollment
1172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain patients
Arm Description
Patients with pain related sexual dysfunction after laparoscopic inguinal hernia repair
Arm Title
Non-pain patients
Arm Description
Patients with no pain related sexual dysfunction after laparoscopic inguinal hernia repair

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients >18 yrs Exclusion Criteria: Research protection
Study Population Description
Patients who have had a laparoscopic inguinal hernia repair
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitte Linderoth, MD
Organizational Affiliation
Section of Surgical Pathophysiology, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section of Surgical Pathophysiology, Rigshospitalet
City
Copenhagen East
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair

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