Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

Bowel Endometriosis Clinical Trial

Official title:

Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100345
• Other study ID #: Bowel Endometriosis
• Secondary ID: 1-10-72-196-13
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: May 8, 2017
• Start date: October 2014
• Est. completion date: February 2017

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Medically treated bowel endometriosis

Exclusion Criteria:

• Age below 18 years

• Bowel resection of any kind

• Cancer

Related Conditions & MeSH terms

• Bowel Endometriosis
• Endometriosis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N	Region Midt

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transvaginal Ultrasound		29 months