Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas

This study has been withdrawn prior to enrollment.
(This study was terminated due to some challenges in recruitment process)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01635543
First received: June 27, 2012
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

Objective:

The aim of this study is to investigate whether Crohn's Disease patients with peri-anal fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's Disease patients that would benefit from sexual health interventions.

Hypothesis:

Crohn's patients with active perianal fistulas will have decreased sexual drive, performance, and satisfaction than those with Crohn's Disease in remission.


Condition
Crohn's Disease
Peri-anal Fistulas
Sexual Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • CD patients without perianal fistulas will be compared with CD patients with perianal fistulas in terms of the percentage of patients that exhibit our definition of sexual dysfunction. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    Student t-test will be used to compare the difference between the fistula versus the control group. Statistical analysis will be two tailed and our p value will be set up as p <0.05. We estimate that 30% of patients with CD will have sexual dysfunction, and that 65% of CD patients with peri-anal fistulas will have sexual dysfunction. Therefore, our calculated sample size for both groups will be around 31 patients each for 80% power with an alpha of 0.05.


Enrollment: 0
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Crohn's Disease with peri-anal fistulas
Identifying Crohn's Disease patients with peri-anal fistulas and suffering from sexual dysfunction.

Detailed Description:

Subject Selection:

Inclusion Criteria Patients in a stable sexual relationship between the ages of 19 and 70 of both sexes with Crohn's disease, as diagnosed based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months will be included in this study. Patients included in this study will have been sexually active in the last 4 weeks.

Exclusion Criteria All patients with known depression will be excluded from the study to prevent confounding the findings.

Patients that qualify for the study will be recruited, and be divided into inactive Crohn's Disease group with no peri-anal fistulas as a control group and an active Crohn's Disease with peri-anal fistula as the study group. Inactive Crohn's Disease patients will be defined as patients with Harvey-Bradshaw scores below 5. Fistula patients will be defined as patients with single or multiple draining fistulas, including perianal fistulas and enterocutaneous fistulas, for at least three months (17).

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men and women ages 19-70 years old with Crohn's disease and sexually active in the last 4 weeks.

Criteria

Inclusion Criteria:

  • patients in a stable sexual relationship between 19-70 years old with Crohn's Disease
  • Crohn's disease diagnosis is based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months
  • Patients will have been sexually active in the last 4 weeks.

Exclusion Criteria:

  • All patients with known depression will be excluded from the study to prevent confounding the findings.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635543

Locations
Canada, British Columbia
Gastroenterology Research Institute
Vancouver, British Columbia, Canada, V6C 2K5
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Brian Bressler, MD University of British Columbia
  More Information

Publications:

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01635543     History of Changes
Other Study ID Numbers: H11-01890
Study First Received: June 27, 2012
Last Updated: October 16, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Crohn Disease
Fistula
Sexual Dysfunctions, Psychological
Rectal Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Sexual and Gender Disorders
Mental Disorders
Intestinal Fistula
Digestive System Fistula
Rectal Diseases

ClinicalTrials.gov processed this record on July 28, 2014