NCT02100345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

March 21, 2014

Last Update Submit

May 8, 2017

Conditions

Bowel Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Transvaginal Ultrasound

    29 months

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with bowel endometriosis

You may qualify if:

  • Medically treated bowel endometriosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, Region Midt, 8200, Denmark

Location

Study Officials

  • Mikkel Mr Seyer-Hansen, MD, PhD

    Department of Obstetrics and Gynecology, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 31, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 9, 2017

Record last verified: 2016-05

Locations

DK(1)