Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life

NCT03779256 | Completed

• 1 other identifier: 2017/1925 REK Sør-Øst D
• Study Type: observational
• Target: 207
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Deep infiltrating endometriosis; Transvaginal ultrasound; Endometriosis rectum; Conservative surgery; Radical surgery; Quality of life; Deep endometriosis

Outcome Measures

Primary Outcomes (7)

• ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS

  Millimeter distance measured on 2D TVS

  Before scheduled surgery

• ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge

  Millimeter distance measured during surgery

  During scheduled surgery

• ENDO1B: Size of bowel lesion measured on the excised bowel lesion.

  Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.

  During surgery.

• ENDO1B: Size of bowel lesion measured with 2D-TVS.

  Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.

  Before scheduled surgery.

• ENDO2: Incidence of low anterior resection syndrome (LARS)

  LARS questionnaire consisting of five questions, each response correlates to a score. Lowest score is 0-20 i.e. no LARS, score 21-29 i.e. minor LARS and score 30-42 i.e. major LARS.

  Preoperatively, 3- and 12-months postoperatively

• ENDO3: Correlation between Lesion to anal verge distance (LAVD) measured with 2D-TVS, MRI and measurements during surgery

  Millimeters of lesion to anal verge distance measured

  Pre-operatively and during surgery

• ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery

  Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.

  Before and during scheduled surgery

Secondary Outcomes (7)

• ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.

  Preoperatively, 3 and 12 months postoperatively

• ENDO1: Type and frequency of complications after bowel surgery

  Through study completion, an average of 1 year

• ENDO2: Quality of life Endometriosis Health Profile-30

  Preoperatively, 3 and 12 months postoperatively

• ENDO2: Sexual function

  Preoperatively, 3 and 12 months postoperatively

• ENDO2: Quality of life before bowel surgery

  Before surgery

Study Arms (1)

Women with bowel endometriosis.

Women with symptomatic bowel endometriosis scheduled for surgical treatment investigated with 2D transvaginal ultrasound before surgery at Hospital St John of God, Vienna, Austria; Oslo university hospital, Oslo, Norway and Nepean Hospital, Sydney, Australia. The women recruited at Oslo university hospital, Norway will also have a magnetic resonance imaging (MRI) of the abdomen and pelvis before surger.

Procedure: 2D transvaginal ultrasound

Interventions

2D transvaginal ultrasound PROCEDURE

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.

Also known as: Segmental bowel resection or, Disc excision of bowel

Women with bowel endometriosis.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible women will be included from tertiary referral centers for deep infiltrating endometriosis. ENDO1 will include women from Oslo University Hospital, Hospital St John of God and Nepean Hospital. Estimated total eligible women: 135. ENDO2 will include women from Oslo University Hospital and Nepean Hospital. Estimated eligible women: 70. ENDO3 will include women from Oslo University Hospital. Estimated eligible women: 40

You may qualify if:

• \- Women of reproductive age, ≥ 18 years old, scheduled for planned laparoscopic or open bowel surgery for deep infiltrating endometriosis with suspected symptomatic bowel lesions.

You may not qualify if:

• \- Postmenopausal women, women \< 18 years old, women with previous bowel surgery. Women who do not speak and read fluent English or Norwegian.

Sponsors & Collaborators

• Oslo University Hospital: lead
• St John of God Hospital, Vienna: collaborator
• Nepean Blue Mountains Local Health District: collaborator

Study Sites (3)

Nepean Hospital

Sydney, NSW2747, Australia

Location

Hospital St John of God

Vienna, 1020, Austria

Location

Oslo university hospital

Oslo, 0424, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bowel excised by discoid excision or segmental resection sent for histopathological examination, which is routine practice after surgery.

MeSH Terms

Conditions

Chronic Pain; Intestinal Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mee Kristine Aas-Eng, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 19, 2018
• Study Start: December 10, 2018
• Primary Completion: January 10, 2020
• Study Completion: March 8, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

NO (1); AU (1)