Sexual DysfunctionNCT01086007
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair
An observational study of Sexual Dysfunction and Hernia, Inguinal, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Sexual Dysfunction, Hernia, Inguinal, Other Chronic Postoperative Pain
- How many people
- 1,172 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: Patients who have had a laparoscopic inguinal hernia repair
Who may be able to join
- Male patients
- >18 yrs
Who cannot join
- Research protection
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Section of Surgical Pathophysiology, Rigshospitalet
Copenhagen East, 2100
About this study
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).
- Keywords
- Groin hernia, chronic pain, Persistent postoperative pain, Laparoscopic inguinal herniotomy, Sexual dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological, Hernia, Inguinal, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicines Initiative
- Responsible party
- Principal investigator, Gitte Linderoth, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gitte Linderoth, MD, Principal investigator, Section of Surgical Pathophysiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086007
- Sponsor's protocol ID
- H-2-2009-126-B
- Status last verified
- Oct 2015
- First submitted
- 11 Mar 2010
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01086007
- Acronym / sponsor ID
- H-2-2009-126-B
- Keywords
- Groin hernia, chronic pain, Persistent postoperative pain, Laparoscopic inguinal herniotomy, Sexual dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,172 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Innovative Medicines Initiative
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who have had a laparoscopic inguinal hernia repair
Key inclusion criteria (2 listed)
- Male patients
- >18 yrs
Key exclusion criteria (1 listed)
- Research protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Linderoth, MD principal investigator
Section of Surgical Pathophysiology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction and Hernia, Inguinal, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.