Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life

NCT ID: NCT03779256

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2021-03-08

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?

Detailed Description

Mild endometriosis normally affects the peritoneum. More advanced form of endometriosis is termed deep infiltrating endometriosis (DIE). In women suffering from DIE, the endometriotic tissue invades the tissue >5mm below the peritoneal surface, affecting organs in the pelvis like the ovaries, uterus, vagina, bladder, ureters and/or bowel. In women with suspected endometriosis, the prevalence of DIE affecting the bowel is found to range from 24.0 to 73.3%. The symptoms of DIE can be debilitating with dysmenorrhoea, dyspareunia, altered bowel motions, dyschezia and/or dysuria. Thus, it may have an immense impact on women's quality of life with societal consequences.

The risk of complications with surgery for deep infiltrating endometriosis (DIE) of the bowel can be severe like anastomotic leak and rectovaginal fistula. Evidence show that there is an increased risk of anastomotic leaks bowel if the anastomosis <5-8cm from the anal verge. DIE of the rectosigmoid colon can be diagnosed by widely available and low-cost two-dimensional transvaginal sonograhpy (2D-TVS) with a high sensitivity and specificity. MRI is comparable to TVS in diagnosis of intestinal endometriosis but is costlier and less available than TVS. MRI has the advantage over 2D-TVS that it is reproducible, the area of interest can be viewed in many planes and the images can be reviewed and compared by same or different examiners over time.

There are two surgical approaches used in women suffering from bowel endometriosis, namely segmental resection of rectosigmoid or nodule excision. Nodule excision may be performed by shaving (not opening the rectum) or disc excision (removing bowel nodule with surrounding rectal wall). The success of pelvic pain reduction following surgery in women suffering from DIE is related to the radicality of surgery. However, some argue a more symptom-guided approach to surgery.

Endometriosis itself and surgical treatment may have immense impact endometriosis can have on a woman's life. Thus, it is essential to discuss the severity of symptoms, any implications of surgery as well as the risk of complications to enable women informed consent. The pre-operative information and decision making is based on symptoms, fertility wish, the clinical examination and diagnostic tests. Consequently, diagnostic tools such as TVS and MRI are important factors to plan and perform a safe procedure with the best possible outcomes for the women.

There are, to the investigator's knowledge, no studies, which demonstrate if there is a correlation between measurement of the size of an endometriotic rectosigmoid lesion with 2D-TVS compared to the actual lesion size in the resected bowel. Additionally, there are no studies that investigate the correlation between the distance between the rectosigmoid lesion and the anal verge, to plan appropriate surgery and estimate risk of serious complications. Furthermore, there are no known studies evaluating the correlation of measurements of bowel lesions when comparing transvaginal 2D-TVS, MRI and surgery. The aim of surgery is to improve women's quality of life and thus it is essential to evaluate results before and after surgery for bowel endometriosis.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

2D transvaginal ultrasound

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Segmental bowel resection or; Disc excision of bowel

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St John of God Hospital, Vienna

OTHER

Sponsor Role: collaborator

Nepean Blue Mountains Local Health District

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristine Aas-Eng

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mee Kristine Aas-Eng, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Nepean Hospital

Sydney, , Australia

Hospital St John of God

Vienna, , Austria

Oslo university hospital

Oslo, , Norway

Countries

Australia; Austria; Norway

Other Identifiers

2017/1925 REK Sør-Øst D

Identifier Type: -

Identifier Source: org_study_id