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Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779256
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
St John of God Hospital, Vienna
Nepean Blue Mountains Local Health District
Information provided by (Responsible Party):
Kristine Aas-Eng, Oslo University Hospital

Tracking Information
First Submitted Date December 4, 2018
First Posted Date December 19, 2018
Last Update Posted Date March 10, 2020
Actual Study Start Date December 10, 2018
Actual Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2020)
  • ENDO1 (Bowel ENDOmetriosis study1): Measurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS [ Time Frame: Before scheduled surgery ]
    Millimeter distance measured on 2D TVS
  • ENDO1: Measurements on the distance between the lower margin of the rectal lesion and anal verge [ Time Frame: During scheduled surgery ]
    Millimeter distance measured during surgery
  • ENDO2 (Bowel ENDOmetriosis study 2): Quality of life before bowel surgery [ Time Frame: Before 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.
  • ENDO2: Quality of life after bowel surgery [ Time Frame: 3 months ]
    GIQLI questionnaire, as described under outcome 3.
  • ENDO2: Quality of life after bowel surgery [ Time Frame: 12 months ]
    GIQLI questionnaire, as described under outcome 3.
  • ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery [ Time Frame: Before and during scheduled surgery ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
Original Primary Outcome Measures
 (submitted: December 17, 2018)
  • ENDO1 (Bowel ENDOmetriosis study1): Measurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS [ Time Frame: Before scheduled surgery ]
    Millimeter distance measured on 2D TVS
  • ENDO1: Measurements on the distance between the lower margin of the rectal lesion and anal verge [ Time Frame: During scheduled surgery ]
    Millimeter distance measured during surgery
  • ENDO2 (Bowel ENDOmetriosis study 2): Quality of life before bowel surgery [ Time Frame: Before 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.
  • ENDO2: Quality of life after bowel surgery [ Time Frame: 3 months ]
    GIQLI questionnaire, as described under outcome 3.
  • ENDO2: Quality of life after bowel surgery [ Time Frame: 12 months ]
    GIQLI questionnaire, as described under outcome 3.
  • ENDO3: Measurements of bowel lesion size with 3D-TVS [ Time Frame: Before scheduled surgery ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
  • ENDO3 (Bowel ENDOmetriosis study 3): Measurements of bowel lesion size with MRI [ Time Frame: Before scheduled surgery ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
  • ENDO3: Measurements of bowel lesion size [ Time Frame: During scheduled surgery ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
Change History
Current Secondary Outcome Measures
 (submitted: March 6, 2020)
  • ENDO1: Size of bowel lesion measured with 2D-TVS. [ Time Frame: Before scheduled surgery. ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
  • ENDO1: Size of bowel lesion measured on the excised bowel lesion. [ Time Frame: During surgery. ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
  • ENDO1: Infiltration depth of the bowel wall measured by 2D-TVS. [ Time Frame: Before scheduled surgery, during surgery. ]
    Affected bowel layer.
  • ENDO1: Infiltration depth of the bowel wall measured in excised lesion [ Time Frame: During surgery. ]
    Affected bowel layer.
  • ENDO1: Correlation between accuracy of diagnosing multiple bowel lesions on 2D-TVS compared to surgery. [ Time Frame: Before scheduled surgery and during surgery. ]
    Counted lesions.
  • ENDO1: Correlation between 2D-TVS staging of DIE using the "Enzian" score and standardized staging of endometriosis during surgery [ Time Frame: Before scheduled surgery and during surgery. ]
    "Enzian" classification
  • ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria. [ Time Frame: Preoperatively, 3 and 12 months postoperatively ]
    Numerical analogue scale ranging from 0 to 10 scored for each symptom, 0 representing no pain and 10 representing worst possible pain
  • ENDO1: Type and frequency of complications after bowel surgery [ Time Frame: Through study completion, an average of 1 year ]
    "Clavien-Dindo" classification of surgical complications
  • ENDO1: Endometriosis Fertility Index (EFI) score [ Time Frame: During surgery. ]
    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.
  • ENDO2: Quality of life [ Time Frame: Preoperatively, 3 and 12 months postoperatively ]
    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).
  • ENDO2: Sexual function [ Time Frame: Preoperatively, 3 and 12 months postoperatively ]
    Using questionnaire - Female Sexual Function Index (FSFI) consisting of 19 questions, minimum score 2.0 (worst score), maximum score 36.0 (best score).
  • ENDO2: Incidence of low anterior resection syndrome (LARS) [ Time Frame: Preoperatively, 3- and 12-months postoperatively ]
    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.
  • ENDO3: Correlation between Lesion to anal verge distance (LAVD) measured with 2D-TVS, MRI and measurements during surgery [ Time Frame: Pre-operatively and during surgery ]
    Millimeters of lesion to anal verge distance measured
Original Secondary Outcome Measures
 (submitted: December 17, 2018)
  • ENDO1: Size of bowel lesion measured with 2D-TVS. [ Time Frame: Before scheduled surgery. ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
  • ENDO1: Size of bowel lesion measured on the excised bowel lesion. [ Time Frame: During surgery. ]
    Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.
  • ENDO1: Infiltration depth of the bowel wall measured by 2D-TVS. [ Time Frame: Before scheduled surgery, during surgery. ]
    Affected bowel layer.
  • ENDO1: Infiltration depth of the bowel wall measured in excised lesion [ Time Frame: During surgery. ]
    Affected bowel layer.
  • ENDO1: Infiltration depth of the bowel wall measured in excised lesion [ Time Frame: Pathological examination up to 6 weeks after surgery ]
    Affected bowel layer.
  • ENDO1: Correlation between accuracy of diagnosing multiple bowel lesions on 2D-TVS compared to surgery. [ Time Frame: Before scheduled surgery and during surgery. ]
    Counted lesions.
  • ENDO1: Correlation between 2D-TVS staging of DIE using the "Enzian" score and standardized staging of endometriosis during surgery [ Time Frame: Before scheduled surgery and during surgery. ]
    "Enzian" classification
  • ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria. [ Time Frame: Preoperatively, 3 and 12 months postoperatively ]
    Numerical analogue scale ranging from 0 to 10 scored for each symptom, 0 representing no pain and 10 representing worst possible pain
  • ENDO1: Type and frequency of complications after bowel surgery [ Time Frame: Through study completion, an average of 1 year ]
    "Clavien-Dindo" classification of surgical complications
  • ENDO1: Endometriosis Fertility Index (EFI) score [ Time Frame: During surgery. ]
    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.
  • ENDO2: Quality of life [ Time Frame: Preoperatively, 3 and 12 months postoperatively ]
    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).
  • ENDO2: Sexual function [ Time Frame: Preoperatively, 3 and 12 months postoperatively ]
    Using questionnaire - Female Sexual Function Index (FSFI) consisting of 19 questions, minimum score 2.0 (worst score), maximum score 36.0 (best score).
  • ENDO2: Incidence of low anterior resection syndrome (LARS) [ Time Frame: Preoperatively, 3- and 12-months postoperatively ]
    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.
  • ENDO3: Correlation between infiltration depth of the bowel measured by 3D-TVS and in the excised lesion after bowel surgery [ Time Frame: Pre-operatively and during surgery ]
    Affected bowel layer.
  • ENDO3: Correlation disease severity classified using ENZIAN score and 3D-TVS and MRI correlates with preoperative classification [ Time Frame: Pre-operatively and during surgery ]
    ENZIAN classification
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life
Official Title ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)
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?
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. Three-dimensional transvaginal sonography (3D-TVS) is a relatively new method in diagnosis of DIE that can be performed at the same time as a routine 2D-TVS. 3D-TVS 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 approaches to the extent of surgery 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 3D-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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Bowel excised by discoid excision or segmental resection sent for histopathological examination, which is routine practice after surgery.
Sampling Method Non-Probability Sample
Study Population

Eligible women will be included from tertiary referral centers for deep infiltrating endometriosis.

ENDO1 will include women from Oslo University Hospital, Hospital St John of God and Nepean Hospital. Estimated total eligible women: 135.

ENDO2 will include women from Oslo University Hospital and Nepean Hospital. Estimated eligible women: 70.

ENDO3 will include women from Oslo University Hospital. Estimated eligible women: 40

Condition
  • Endometriosis Related Pain
  • Quality of Life
  • Pain, Chronic
  • Bowel Dysfunction
  • Endometriosis Rectum
  • Deep Infiltrating Endometriosis
Intervention Procedure: 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.
Other Names:
  • Segmental bowel resection or
  • Disc excision of bowel
Study Groups/Cohorts Women with bowel endometriosis.
Women with symptomatic bowel endometriosis scheduled for surgical treatment investigated with 2D and 3D transvaginal ultrasound before surgery.
Intervention: Procedure: 2D and 3D transvaginal ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 17, 2018)
135
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Actual Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Austria,   Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03779256
Other Study ID Numbers 2017/1925 REK Sør-Øst D
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Kristine Aas-Eng, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators
  • St John of God Hospital, Vienna
  • Nepean Blue Mountains Local Health District
Investigators
Principal Investigator: Mee Kristine Aas-Eng, MD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date March 2020