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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)
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Secondary ID [1]
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2017/1925 REK Sør-Øst D
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Universal Trial Number (UTN)
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Trial acronym
ENDO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis Related Pain
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Quality of Life
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Pain, Chronic
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Bowel Dysfunction
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Endometriosis Rectum
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Deep Infiltrating Endometriosis
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Deep Endometriosis
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Condition category
Condition code
Reproductive Health and Childbirth
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
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Menstruation and menopause
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Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS
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Assessment method [1]
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Millimeter distance measured on 2D TVS
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Timepoint [1]
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Before scheduled surgery
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Primary outcome [2]
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ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge
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Assessment method [2]
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Millimeter distance measured during surgery
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Timepoint [2]
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During scheduled surgery
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Primary outcome [3]
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ENDO1B: Size of bowel lesion measured on the excised bowel lesion.
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Assessment method [3]
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Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
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Timepoint [3]
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During surgery.
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Primary outcome [4]
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ENDO1B: Size of bowel lesion measured with 2D-TVS.
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Assessment method [4]
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Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
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Timepoint [4]
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Before scheduled surgery.
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Primary outcome [5]
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ENDO2: Incidence of low anterior resection syndrome (LARS)
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Assessment method [5]
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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.
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Timepoint [5]
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Preoperatively, 3- and 12-months postoperatively
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Primary outcome [6]
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ENDO3: Correlation between Lesion to anal verge distance (LAVD) measured with 2D-TVS, MRI and measurements during surgery
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Assessment method [6]
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Millimeters of lesion to anal verge distance measured
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Timepoint [6]
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Pre-operatively and during surgery
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Primary outcome [7]
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ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery
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Assessment method [7]
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Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
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Timepoint [7]
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Before and during scheduled surgery
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Secondary outcome [1]
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ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.
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Assessment method [1]
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Numerical analogue scale ranging from 0 to 10 scored for each symptom, 0 representing no pain and 10 representing worst possible pain
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Timepoint [1]
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Preoperatively, 3 and 12 months postoperatively
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Secondary outcome [2]
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ENDO1: Type and frequency of complications after bowel surgery
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Assessment method [2]
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"Clavien-Dindo" classification of surgical complications
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Timepoint [2]
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Through study completion, an average of 1 year
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Secondary outcome [3]
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ENDO2: Quality of life Endometriosis Health Profile-30
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Assessment method [3]
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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).
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Timepoint [3]
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Preoperatively, 3 and 12 months postoperatively
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Secondary outcome [4]
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ENDO2: Sexual function
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Assessment method [4]
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Using questionnaire - Female Sexual Function Index (FSFI) consisting of 19 questions, minimum score 2.0 (worst score), maximum score 36.0 (best score).
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Timepoint [4]
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Preoperatively, 3 and 12 months postoperatively
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Secondary outcome [5]
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ENDO2: Quality of life before bowel surgery
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Assessment method [5]
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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.
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Timepoint [5]
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Before surgery
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Secondary outcome [6]
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ENDO2: Quality of life after bowel surgery
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Assessment method [6]
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GIQLI questionnaire
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Timepoint [6]
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3 months
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Secondary outcome [7]
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ENDO2: Quality of life after bowel surgery
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Assessment method [7]
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GIQLI questionnaire
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Timepoint [7]
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12 months
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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.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/03/2021
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Sample size
Target
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Accrual to date
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Final
207
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Nepean Hospital - Sydney
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Recruitment postcode(s) [1]
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NSW2747 - Sydney
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Vienna
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Country [2]
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Norway
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State/province [2]
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Oslo
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Funding & Sponsors
Primary sponsor type
Other
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Name
Oslo University Hospital
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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St John of God Hospital, Vienna
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Nepean Blue Mountains Local Health District
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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?
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03779256
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mee Kristine Aas-Eng, MD
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Address
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Oslo University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03779256
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