Pain Related Sexual Dysfunction After Laparoscopic Inguin... | NCT01086007

Studies
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair

NCT01086007

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Oct 30, 2015Estimated

Enrollment

1,172Actual

Phase

Not provided

Conditions

Sexual Dysfunction
Hernia, Inguinal
Other Chronic Postoperative Pain

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Mar 11, 2010

First Submission Date that Met QC Criteria

Mar 11, 2010

First Posted Date

Mar 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2015

Last Update Posted Date

Oct 30, 2015Estimated

Name	Class
Innovative Medicines Initiative	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

1,172Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pain patients		Patients with pain related sexual dysfunction after laparoscopic inguinal hernia repair
Non-pain patients		Patients with no pain related sexual dysfunction after laparoscopic inguinal hernia repair

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients
>18 yrs

Exclusion Criteria:

Research protection

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Patients who have had a laparoscopic inguinal hernia repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gitte Linderoth, MD	Section of Surgical Pathophysiology, Rigshospitalet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section of Surgical Pathophysiology, Rigshospitalet		Copenhagen East		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D012735	Sexual Dysfunction, Physiological
D006552	Hernia, Inguinal
D059350	Chronic Pain

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D046449	Hernia, Abdominal
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided