Overview

This trial is active, not recruiting.

Condition bowel endometriosis
Sponsor University of Aarhus
Start date October 2014
End date February 2017
Trial size 100 participants
Trial identifier NCT02100345, 1-10-72-196-13, Bowel Endometriosis

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Transvaginal Ultrasound
time frame: 29 months

Eligibility Criteria

Female participants from 18 years up to 80 years old.

Inclusion Criteria: - Medically treated bowel endometriosis Exclusion Criteria: - Age below 18 years - Bowel resection of any kind - Cancer

Additional Information

Official title Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.