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Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

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ClinicalTrials.gov Identifier: NCT02100345
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of abdominal pain and suffering during women's menstrual periods. A subgroup of patients with DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to assess the need for follow-up with transvaginal ultrasound during medical treatment.

Hypotheses:

Symptoms will follow growth of rectosigmoid endometriosis.

Material and methods:

Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and treatment with hormonal intrauterine device or continuous oral contraceptives will receive a questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion, (6) and 12 months later.

Perspectives:

Patients treated conservatively may be followed by questionnaires, thereby reducing the need for time consuming clinical controls.


Condition or disease
Bowel Endometriosis

Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound
Actual Study Start Date : October 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Transvaginal Ultrasound [ Time Frame: 29 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with bowel endometriosis
Criteria

Inclusion Criteria:

  • Medically treated bowel endometriosis

Exclusion Criteria:

  • Age below 18 years
  • Bowel resection of any kind
  • Cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100345


Locations
Denmark
Aarhus University Hospital
Aarhus N, Region Midt, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Mikkel Mr Seyer-Hansen, MD, PhD Department of Obstetrics and Gynecology, Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02100345     History of Changes
Other Study ID Numbers: Bowel Endometriosis
1-10-72-196-13 ( Other Identifier: Local Ethics Committee )
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2016

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female