The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03779256
Ethics application status
Date submitted
4/12/2018
Date registered
17/12/2018
Date last updated
17/12/2018

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
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 and 3D transvaginal ultrasound

Women with bowel endometriosis. - Women with symptomatic bowel endometriosis scheduled for surgical treatment investigated with 2D and 3D transvaginal ultrasound before surgery.


Treatment: Surgery: 2D and 3D transvaginal ultrasound
Transvaginal ultrasound is part of routine pre-operative examination of the patient before surgery is scheduled. Described surgical treatment interventions is standard practice used to alleviate patient symptoms.

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

Outcomes
Primary outcome [1] 0 0
ENDO1 (Bowel ENDOmetriosis study1): Measurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS - Millimeter distance measured on 2D TVS
Timepoint [1] 0 0
Before scheduled surgery
Primary outcome [2] 0 0
ENDO1: Measurements on the distance between the lower margin of the rectal lesion and anal verge - Millimeter distance measured during surgery
Timepoint [2] 0 0
During scheduled surgery
Primary outcome [3] 0 0
ENDO2 (Bowel ENDOmetriosis study 2): 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.
Timepoint [3] 0 0
Before surgery
Primary outcome [4] 0 0
ENDO2: Quality of life after bowel surgery - GIQLI questionnaire, as described under outcome 3.
Timepoint [4] 0 0
3 months
Primary outcome [5] 0 0
ENDO2: Quality of life after bowel surgery - GIQLI questionnaire, as described under outcome 3.
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
ENDO3: Measurements of bowel lesion size with 3D-TVS - Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
Timepoint [6] 0 0
Before scheduled surgery
Primary outcome [7] 0 0
ENDO3 (Bowel ENDOmetriosis study 3): Measurements of bowel lesion size with MRI - Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
Timepoint [7] 0 0
Before scheduled surgery
Primary outcome [8] 0 0
ENDO3: Measurements of bowel lesion size - Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
Timepoint [8] 0 0
During scheduled surgery
Secondary outcome [1] 0 0
ENDO1: 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.
Timepoint [1] 0 0
Before scheduled surgery.
Secondary outcome [2] 0 0
ENDO1: 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.
Timepoint [2] 0 0
During surgery.
Secondary outcome [3] 0 0
ENDO1: Infiltration depth of the bowel wall measured by 2D-TVS. - Affected bowel layer.
Timepoint [3] 0 0
Before scheduled surgery, during surgery.
Secondary outcome [4] 0 0
ENDO1: Infiltration depth of the bowel wall measured in excised lesion - Affected bowel layer.
Timepoint [4] 0 0
During surgery.
Secondary outcome [5] 0 0
ENDO1: Infiltration depth of the bowel wall measured in excised lesion - Affected bowel layer.
Timepoint [5] 0 0
Pathological examination up to 6 weeks after surgery
Secondary outcome [6] 0 0
ENDO1: Correlation between accuracy of diagnosing multiple bowel lesions on 2D-TVS compared to surgery. - Counted lesions.
Timepoint [6] 0 0
Before scheduled surgery and during surgery.
Secondary outcome [7] 0 0
ENDO1: Correlation between 2D-TVS staging of DIE using the "Enzian" score and standardized staging of endometriosis during surgery - "Enzian" classification
Timepoint [7] 0 0
Before scheduled surgery and during surgery.
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Preoperatively, 3 and 12 months postoperatively
Secondary outcome [9] 0 0
ENDO1: Type and frequency of complications after bowel surgery - "Clavien-Dindo" classification of surgical complications
Timepoint [9] 0 0
Through study completion, an average of 1 year
Secondary outcome [10] 0 0
ENDO1: Endometriosis Fertility Index (EFI) score - Surgical staging using EFI and revised American Society for Reproductive Medicine (rASRM) classification. EFI is calculated based on history of the patient, surgical findings and staging with the rASRM. EFI score ranges from 0 to 10, 0 giving the worst prognosis and 10 giving the best prognosis.
Timepoint [10] 0 0
During surgery.
Secondary outcome [11] 0 0
ENDO2: Quality of life - 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).
Timepoint [11] 0 0
Preoperatively, 3 and 12 months postoperatively
Secondary outcome [12] 0 0
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).
Timepoint [12] 0 0
Preoperatively, 3 and 12 months postoperatively
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Preoperatively, 3- and 12-months postoperatively
Secondary outcome [14] 0 0
ENDO3: Correlation between infiltration depth of the bowel measured by 3D-TVS and in the excised lesion after bowel surgery - Affected bowel layer.
Timepoint [14] 0 0
Pre-operatively and during surgery
Secondary outcome [15] 0 0
ENDO3: Correlation disease severity classified using ENZIAN score and 3D-TVS and MRI correlates with preoperative classification - ENZIAN classification
Timepoint [15] 0 0
Pre-operatively and during surgery

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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, the sized of the nodule can be
measured with three dimensional (3D) vaginal ultrasound. Our study would like to investigate
the diagnostic value of 2D and 3D vaginal ultrasound and 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 vaginal 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 3D vaginal 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/show/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
Mee Kristine Aas-Eng, MD
Address 0 0
Country 0 0
Phone 0 0
+4741068560
Fax 0 0
Email 0 0
kristineaaseng@gmail.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable