Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life

Quality of Life Clinical Trial

— ENDO  

Official title:

ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779256
• Other study ID #: 2017/1925 REK Sør-Øst D
• Status: Completed
• Start date: December 10, 2018
• Est. completion date: March 8, 2021

Study information

• Verified date: March 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: March 8, 2021
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Australia	Nepean Hospital	Sydney
Austria	Hospital St John of God	Vienna
Norway	Oslo university hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Nepean Blue Mountains Local Health District, St John of God Hospital, Vienna

Countries where clinical trial is conducted

Australia,  Austria,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge	Millimeter distance measured during surgery	During scheduled surgery
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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	ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.	Numerical analogue scale ranging from 0 to 10 scored for each symptom, 0 representing no pain and 10 representing worst possible pain	Preoperatively, 3 and 12 months postoperatively
Secondary	ENDO1: Type and frequency of complications after bowel surgery	"Clavien-Dindo" classification of surgical complications	Through study completion, an average of 1 year
Secondary	ENDO2: Quality of life Endometriosis Health Profile-30	Using questionnaire - Endometriosis Health Profile (EHP-30), consisting of a core questionnaire with 30 items grouped into 5 scales and modular questionnaire consisting of 23 items grouped into 6 scales. All scales have a minimum score of 0 (indicating low disability) and a maximum score of 100 (indicating high disability).	Preoperatively, 3 and 12 months postoperatively
Secondary	ENDO2: Sexual function	Using questionnaire - Female Sexual Function Index (FSFI) consisting of 19 questions, minimum score 2.0 (worst score), maximum score 36.0 (best score).	Preoperatively, 3 and 12 months postoperatively
Secondary	ENDO2: Quality of life before bowel surgery	GIQLI (gastrointestinal quality of life index) questionnaire. 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.	Before surgery
Secondary	ENDO2: Quality of life after bowel surgery	GIQLI questionnaire	3 months
Secondary	ENDO2: Quality of life after bowel surgery	GIQLI questionnaire	12 months