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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03779256




Registration number
NCT03779256
Ethics application status
Date submitted
4/12/2018
Date registered
19/12/2018
Date last updated
10/03/2021

Titles & IDs
Public title
Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life
Scientific title
ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)
Secondary ID [1] 0 0
2017/1925 REK Sør-Øst D
Universal Trial Number (UTN)
Trial acronym
ENDO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis Related Pain 0 0
Quality of Life 0 0
Pain, Chronic 0 0
Bowel Dysfunction 0 0
Endometriosis Rectum 0 0
Deep Infiltrating Endometriosis 0 0
Deep Endometriosis 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - 2D transvaginal ultrasound

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.


Treatment: Surgery: 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 code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS
Timepoint [1] 0 0
Before scheduled surgery
Primary outcome [2] 0 0
ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge
Timepoint [2] 0 0
During scheduled surgery
Primary outcome [3] 0 0
ENDO1B: Size of bowel lesion measured on the excised bowel lesion.
Timepoint [3] 0 0
During surgery.
Primary outcome [4] 0 0
ENDO1B: Size of bowel lesion measured with 2D-TVS.
Timepoint [4] 0 0
Before scheduled surgery.
Primary outcome [5] 0 0
ENDO2: Incidence of low anterior resection syndrome (LARS)
Timepoint [5] 0 0
Preoperatively, 3- and 12-months postoperatively
Primary outcome [6] 0 0
ENDO3: Correlation between Lesion to anal verge distance (LAVD) measured with 2D-TVS, MRI and measurements during surgery
Timepoint [6] 0 0
Pre-operatively and during surgery
Primary outcome [7] 0 0
ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery
Timepoint [7] 0 0
Before and during scheduled surgery
Secondary outcome [1] 0 0
ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.
Timepoint [1] 0 0
Preoperatively, 3 and 12 months postoperatively
Secondary outcome [2] 0 0
ENDO1: Type and frequency of complications after bowel surgery
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
ENDO2: Quality of life Endometriosis Health Profile-30
Timepoint [3] 0 0
Preoperatively, 3 and 12 months postoperatively
Secondary outcome [4] 0 0
ENDO2: Sexual function
Timepoint [4] 0 0
Preoperatively, 3 and 12 months postoperatively
Secondary outcome [5] 0 0
ENDO2: Quality of life before bowel surgery
Timepoint [5] 0 0
Before surgery
Secondary outcome [6] 0 0
ENDO2: Quality of life after bowel surgery
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
ENDO2: Quality of life after bowel surgery
Timepoint [7] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Postmenopausal women, women < 18 years old, women with previous bowel surgery. Women who do not speak and read fluent English or Norwegian.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/03/2021
Sample size
Target
Accrual to date
Final
207
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nepean Hospital - Sydney
Recruitment postcode(s) [1] 0 0
NSW2747 - Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Norway
State/province [2] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Other
Name
Oslo University Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St John of God Hospital, Vienna
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Nepean Blue Mountains Local Health District
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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?
Trial website
https://clinicaltrials.gov/study/NCT03779256
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mee Kristine Aas-Eng, MD
Address 0 0
Oslo University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03779256