Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

NCT ID: NCT02100345

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-02-28

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.

Conditions

Bowel Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Medically treated bowel endometriosis

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikkel Mr Seyer-Hansen, MD, PhD

Role: STUDY_DIRECTOR

Department of Obstetrics and Gynecology, Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus N, Region Midt, Denmark

Countries

Denmark

Other Identifiers

1-10-72-196-13

Identifier Type: OTHER

Identifier Source: secondary_id

Bowel Endometriosis

Identifier Type: -

Identifier Source: org_study_id