Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life

Summary

Endometriosis on the bowel is a benign condition that can cause major complaints and severely affect the quality of life of women of fertile age. If medical treatment is not enough to improve pain and/or other symptoms it may be necessary to undergo major surgical treatment and removal of the endometriosis nodule on the bowel. Such extensive surgical treatment carries risks of serious complications. Therefore, a thorough diagnostic work-up before surgery is important to know the extent of disease. This will provide women with the best possible information and for the surgeon to plan the operation. The risk of complications increases as the bowel endometriosis is localized closer to the anus as well and/or if the bowel nodule is large.

The distance between the anus and the nodule and the size of the nodule can be measured with two dimensional (2D) vaginal ultrasound. Additionally, Magnetic resonance imaging (MRI) is also used in some countries for these same measurements. Our study would like to investigate the diagnostic value of 2D ultrasound and MRI as well as learn more about women's quality of life before and after surgery. The investigators have designed the study to evaluate the following three questions into three studies ENDO1, ENDO2 and ENDO3:

* ENDO1: How good is 2D transvaginal ultrasound at measuring the size of the bowel endometriosis nodule and the distance between anus and the lower part of the bowel nodule compared to measurements done during surgery?
* ENDO2: What is the quality of life, sexual and bowel function of women before and 3- and 12-months after surgery due to bowel endometriosis? Questionnaires will be used.
* ENDO3: How good is 2D transvaginal ultrasound at measuring the size of the bowel endometriosis nodule compared to magnetic resonance imaging (MRI) and measurements done during surgery?

Conditions

• Endometriosis Related Pain
• Quality of Life
• Pain, Chronic
• Bowel Dysfunction
• Endometriosis Rectum
• Deep Infiltrating Endometriosis
• Deep Endometriosis

Interventions

PROCEDURE

2D transvaginal ultrasound

Transvaginal ultrasound is part of routine pre-operative examination of the women before surgery is scheduled. Described surgical treatment interventions is standard practice used to alleviate patient symptoms. Women recruited at Oslo university hospital, Norway will also have an MRI performed pre-operatively.

Sponsors & Collaborators

• St John of God Hospital, Vienna

  collaborator OTHER

• Nepean Blue Mountains Local Health District

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Mee Kristine Aas-Eng, MD · Oslo University Hospital

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-10

Primary Completion

2020-01-10

Completion

2021-03-08

Countries

• Australia
• Austria
• Norway

Study Locations