Endometriosis Related PainENDONCT03779256
Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life
An observational study of Endometriosis Related Pain and Quality of Life, run by Oslo University Hospital at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis Related Pain, Quality of Life, Pain, Chronic
- What is being tested?
- 2D transvaginal ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 10 Dec 2018to 8 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- Women of reproductive age, ≥ 18 years old, scheduled for planned laparoscopic or open bowel surgery for deep infiltrating endometriosis with suspected symptomatic bowel lesions.
Who cannot join
- Postmenopausal women, women < 18 years old, women with previous bowel surgery. Women who do not speak and read fluent English or Norwegian.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)
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?
Read the 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. 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.
- Conditions
- Endometriosis Related Pain, Quality of Life, Pain, Chronic, Bowel Dysfunction, Endometriosis Rectum, Deep Infiltrating Endometriosis
- Being tested
- 2D transvaginal ultrasound
- Keywords
- Deep infiltrating endometriosis, Transvaginal ultrasound, Endometriosis rectum, Conservative surgery, Radical surgery, Quality of life, Deep endometriosis
- Medical subject headings
- Chronic Pain, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D transvaginal ultrasoundProcedure or surgery
Also called Segmental bowel resection or, Disc excision of bowel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 2D transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS
Millimeter distance measured on 2D TVS
Measured: Before scheduled surgery
ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge
Millimeter distance measured during surgery
Measured: During scheduled surgery
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.
Measured: During surgery.
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.
Measured: Before scheduled surgery.
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.
Measured: Preoperatively, 3- and 12-months postoperatively
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
Measured: Pre-operatively and during surgery
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.
Measured: Before and during scheduled surgery
Secondary outcomes (7)
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
Measured: Preoperatively, 3 and 12 months postoperatively
ENDO1: Type and frequency of complications after bowel surgery
"Clavien-Dindo" classification of surgical complications
Measured: Through study completion, an average of 1 year
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).
Measured: Preoperatively, 3 and 12 months postoperatively
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).
Measured: Preoperatively, 3 and 12 months postoperatively
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.
Measured: Before surgery
ENDO2: Quality of life after bowel surgery
GIQLI questionnaire
Measured: 3 months
ENDO2: Quality of life after bowel surgery
GIQLI questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start10 Dec 2018
- Primary completion10 Jan 2020
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis Related PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St John of God Hospital, Vienna, Nepean Blue Mountains Local Health District
- Responsible party
- Principal investigator, Kristine Aas-Eng, Oslo University Hospital
- Investigators
- Mee Kristine Aas-Eng, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779256
- Sponsor's protocol ID
- 2017/1925 REK Sør-Øst D
- Acronym
- ENDO
- Status last verified
- Mar 2021
- First submitted
- 4 Dec 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)
- ClinicalTrials.gov ID
- NCT03779256
- Acronym / sponsor ID
- ENDO / 2017/1925 REK Sør-Øst D
- Conditions
- Endometriosis Related Pain, Quality of Life, Pain, Chronic, Bowel Dysfunction, Endometriosis Rectum, Deep Infiltrating Endometriosis
- Keywords
- Deep infiltrating endometriosis, Transvaginal ultrasound, Endometriosis rectum, Conservative surgery, Radical surgery, Quality of life, Deep endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St John of God Hospital, Vienna, Nepean Blue Mountains Local Health District
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with bowel endometriosis. | – | Procedure: 2D transvaginal ultrasoundWomen 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Women of reproductive age, ≥ 18 years old, scheduled for planned laparoscopic or open bowel surgery for deep infiltrating endometriosis with suspected symptomatic bowel lesions.
Key exclusion criteria (1 listed)
- Postmenopausal women, women < 18 years old, women with previous bowel surgery. Women who do not speak and read fluent English or Norwegian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D transvaginal ultrasoundAlso: Segmental bowel resection or, Disc excision of bowelTransvaginal 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. | Procedure or surgery | Women with bowel endometriosis. |
Primary outcome
ENDO1AMeasurements 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
ENDO1A: 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
ENDO1B: 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.
ENDO1B: 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.
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
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.
7 secondary outcomes
ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.
Time frame: Preoperatively, 3 and 12 months postoperatively
ENDO1: Type and frequency of complications after bowel surgery
Time frame: Through study completion, an average of 1 year
ENDO2: Quality of life Endometriosis Health Profile-30
Time frame: Preoperatively, 3 and 12 months postoperatively
ENDO2: Sexual function
Time frame: Preoperatively, 3 and 12 months postoperatively
ENDO2: Quality of life before bowel surgery
Time frame: Before surgery
ENDO2: Quality of life after bowel surgery
Time frame: 3 months
ENDO2: Quality of life after bowel surgery
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mee Kristine Aas-Eng, MD principal investigator
Oslo University Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis Related Pain and Quality of Life, run by Oslo University Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Austria, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS (time frame: Before scheduled surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.