Deep Infiltrating Endometriosis With or Without Bowel InvolvementNCT06876376
Intraoperative Ultrasound in Bowel Deep Endometriosis
An observational study of Deep Infiltrating Endometriosis With or Without Bowel Involvement, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
This study investigates the use of intraoperative transvaginal (IOTVUS) and/or endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Deep Infiltrating Endometriosis With or Without Bowel Involvement
- What is being tested?
- intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Adult, Older adult
Study population: Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.
Who may be able to join
- Preoperative sonographic and/or MRI findings suggestive of bowel DIE (uterosacral ligaments, posterior vaginal wall, parametrium, retrocervical area, rectovaginal septum, rectum, and/or sigmoid colon).
- Scheduled for surgical treatment (laparoscopy or robot-assisted laparoscopy).
- Planned postoperative follow-up for at least 12 months.
- Written informed consent provided before surgery.
Who cannot join
- Planned surgery for diagnostic purposes only.
- Pregnancy at the time of enrollment.
- Poor understanding of Spanish or English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, 08037
Ignacio Rodríguez, BsC, 0034932274700 ext. 22029, nacrod@dexeus.com
Yannick Hurni, MD
About this study
Official title: Intraoperative Transvaginal and Endorectal Ultrasound for the Assessment of Bowel Deep Infiltrating Endometriosis
This study investigates the use of intraoperative transvaginal (IOTVUS) and/or endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE).
Read the detailed description
Bowel DIE is a severe form of endometriosis that often infiltrates the rectum and the sigmoid colon, requiring precise surgical techniques to achieve complete excision while minimizing unnecessary resections of healthy tissues and organs. Current preoperative imaging techniques, such as transvaginal ultrasound and magnetic resonance imaging, are often limited in their ability to assess lesion depth and extent in cases of severe pelvic anatomical distortion. Intraoperative ultrasound offers a real-time evaluation after rectal mobilization, allowing for a more accurate assessment of lesion location, depth, and bowel wall infiltration. The primary objectives are to evaluate the feasibility and accuracy of intraoperative ultrasound in detecting rectal and RSJ DIE nodules and to guide surgical decision-making. Secondary objectives include determining the impact of these techniques on surgical outcomes, postoperative pain management, and quality of life. The goal is to enhance surgical decision-making by accurately assessing lesion depth and location, potentially reducing unnecessary colorectal resections or avoiding inadvertent retention of endometrial nodules. Participants will complete health and pain questionnaires preoperatively and at 3, 6, and 12 months postoperatively, evaluating dysmenorrhea, dyspareunia, dyschezia, and quality of life using validated tools. The study will also document intraoperative findings, surgical decisions, complications, and postoperative outcomes. By combining IOTVUS and IOERUS with existing surgical approaches, this study seeks to establish these techniques as standard tools for improving surgical precision in bowel DIE cases. Results could provide valuable insights for tailoring interventions to patient-specific disease presentations, enhancing long-term management strategies.
- Being tested
- intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis
- Keywords
- Endometriosis, Intraoperative Ultrasound, Ultrasound, surgery, minimally invasive surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosisProcedure or surgery
Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.
| Study group | Role | What they receive |
|---|---|---|
| posterior compartment deep infiltrating endometriosis | Not described Receives: Procedure: intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intraoperative ultrasound
- The proportion of patients in whom intraoperative ultrasound techniques can successfully identify rectal or rectosigmoid junction deep infiltrating endometriosis nodules during surgery.
Measured: Day of surgery
Accuracy of intraoperative ultrasound
- Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.
Measured: Day of surgery
Secondary outcomes (3)
Impact on Surgical Decision-Making
- Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings.
Measured: Day of surgery
Postoperative Pain and Function
Improvement in pain symptoms and quality of life
Measured: at 3-months, 6-months and 12-months follow-up
Complication Rates
- Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III).
Measured: From day of surgery to 7 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start20 Jan 2025
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Deep Infiltrating Endometriosis With or Without Bowel InvolvementStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876376
- Sponsor's protocol ID
- FSD-DIE-2024-18
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
PubMed 15541453Berkley KJ, Rapkin AJ, Papka RE. The pains of endometriosis. Science. 2005 Jun 10;308(5728):1587-9. doi: 10.1126/science.1111445.
PubMed 15947176de Ziegler D, Borghese B, Chapron C. Endometriosis and infertility: pathophysiology and management. Lancet. 2010 Aug 28;376(9742):730-8. doi: 10.1016/S0140-6736(10)60490-4.
PubMed 20801404Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30.
PubMed 21718982Vercellini P, Vigano P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261-75. doi: 10.1038/nrendo.2013.255. Epub 2013 Dec 24.
PubMed 24366116Chapron C, Chopin N, Borghese B, Foulot H, Dousset B, Vacher-Lavenu MC, Vieira M, Hasan W, Bricou A. Deeply infiltrating endometriosis: pathogenetic implications of the anatomical distribution. Hum Reprod. 2006 Jul;21(7):1839-45. doi: 10.1093/humrep/del079. Epub 2006 Mar 16.
PubMed 16543256Scioscia M, Bruni F, Ceccaroni M, Steinkasserer M, Stepniewska A, Minelli L. Distribution of endometriotic lesions in endometriosis stage IV supports the menstrual reflux theory and requires specific preoperative assessment and therapy. Acta Obstet Gynecol Scand. 2011 Feb;90(2):136-9. doi: 10.1111/j.1600-0412.2010.01008.x. Epub 2010 Dec 2.
PubMed 21241258Donnez O, Roman H. Choosing the right surgical technique for deep endometriosis: shaving, disc excision, or bowel resection? Fertil Steril. 2017 Dec;108(6):931-942. doi: 10.1016/j.fertnstert.2017.09.006.
PubMed 29202966Abrao MS, Andres MP, Barbosa RN, Bassi MA, Kho RM. Optimizing Perioperative Outcomes with Selective Bowel Resection Following an Algorithm Based on Preoperative Imaging for Bowel Endometriosis. J Minim Invasive Gynecol. 2020 May-Jun;27(4):883-891. doi: 10.1016/j.jmig.2019.06.010. Epub 2019 Jun 22.
PubMed 31238150Puppo A, Olearo E, Gattolin A, Rimonda R, Novelli A, Ceccaroni M. Intraoperative Ultrasound for Bowel Deep Infiltrating Endometriosis: A Preliminary Report. J Ultrasound Med. 2021 Jul;40(7):1417-1425. doi: 10.1002/jum.15511. Epub 2020 Sep 29.
PubMed 32991006
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Transvaginal and Endorectal Ultrasound for the Assessment of Bowel Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT06876376
- Acronym / sponsor ID
- FSD-DIE-2024-18
- Keywords
- Endometriosis, Intraoperative Ultrasound, Ultrasound, surgery, minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Mar 2025 (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.
This study investigates the use of intraoperative transvaginal (IOTVUS) and/or endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE).
Detailed description
Bowel DIE is a severe form of endometriosis that often infiltrates the rectum and the sigmoid colon, requiring precise surgical techniques to achieve complete excision while minimizing unnecessary resections of healthy tissues and organs. Current preoperative imaging techniques, such as transvaginal ultrasound and magnetic resonance imaging, are often limited in their ability to assess lesion depth and extent in cases of severe pelvic anatomical distortion. Intraoperative ultrasound offers a real-time evaluation after rectal mobilization, allowing for a more accurate assessment of lesion location, depth, and bowel wall infiltration. The primary objectives are to evaluate the feasibility and accuracy of intraoperative ultrasound in detecting rectal and RSJ DIE nodules and to guide surgical decision-making. Secondary objectives include determining the impact of these techniques on surgical outcomes, postoperative pain management, and quality of life. The goal is to enhance surgical decision-making by accurately assessing lesion depth and location, potentially reducing unnecessary colorectal resections or avoiding inadvertent retention of endometrial nodules. Participants will complete health and pain questionnaires preoperatively and at 3, 6, and 12 months postoperatively, evaluating dysmenorrhea, dyspareunia, dyschezia, and quality of life using validated tools. The study will also document intraoperative findings, surgical decisions, complications, and postoperative outcomes. By combining IOTVUS and IOERUS with existing surgical approaches, this study seeks to establish these techniques as standard tools for improving surgical precision in bowel DIE cases. Results could provide valuable insights for tailoring interventions to patient-specific disease presentations, enhancing long-term management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| posterior compartment deep infiltrating endometriosis | – | Procedure: intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.
Key inclusion criteria (4 listed)
- Preoperative sonographic and/or MRI findings suggestive of bowel DIE (uterosacral ligaments, posterior vaginal wall, parametrium, retrocervical area, rectovaginal septum, rectum, and/or sigmoid colon).
- Scheduled for surgical treatment (laparoscopy or robot-assisted laparoscopy).
- Planned postoperative follow-up for at least 12 months.
- Written informed consent provided before surgery.
Key exclusion criteria (3 listed)
- Planned surgery for diagnostic purposes only.
- Pregnancy at the time of enrollment.
- Poor understanding of Spanish or English.
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 |
|---|---|---|
| intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosisWomen with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital. | Procedure or surgery | posterior compartment deep infiltrating endometriosis |
Primary outcome
Feasibility of intraoperative ultrasound
Time frame: Day of surgery
o The proportion of patients in whom intraoperative ultrasound techniques can successfully identify rectal or rectosigmoid junction deep infiltrating endometriosis nodules during surgery.
Accuracy of intraoperative ultrasound
Time frame: Day of surgery
o Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.
3 secondary outcomes
Impact on Surgical Decision-Making
Time frame: Day of surgery
Postoperative Pain and Function
Time frame: at 3-months, 6-months and 12-months follow-up
Complication Rates
Time frame: From day of surgery to 7 days later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 15541453Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
- Background: PubMed 15947176Berkley KJ, Rapkin AJ, Papka RE. The pains of endometriosis. Science. 2005 Jun 10;308(5728):1587-9. doi: 10.1126/science.1111445.
- Background: PubMed 20801404de Ziegler D, Borghese B, Chapron C. Endometriosis and infertility: pathophysiology and management. Lancet. 2010 Aug 28;376(9742):730-8. doi: 10.1016/S0140-6736(10)60490-4.
- Background: PubMed 21718982Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30.
- Background: PubMed 24366116Vercellini P, Vigano P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261-75. doi: 10.1038/nrendo.2013.255. Epub 2013 Dec 24.
- Background: PubMed 16543256Chapron C, Chopin N, Borghese B, Foulot H, Dousset B, Vacher-Lavenu MC, Vieira M, Hasan W, Bricou A. Deeply infiltrating endometriosis: pathogenetic implications of the anatomical distribution. Hum Reprod. 2006 Jul;21(7):1839-45. doi: 10.1093/humrep/del079. Epub 2006 Mar 16.
- Background: PubMed 21241258Scioscia M, Bruni F, Ceccaroni M, Steinkasserer M, Stepniewska A, Minelli L. Distribution of endometriotic lesions in endometriosis stage IV supports the menstrual reflux theory and requires specific preoperative assessment and therapy. Acta Obstet Gynecol Scand. 2011 Feb;90(2):136-9. doi: 10.1111/j.1600-0412.2010.01008.x. Epub 2010 Dec 2.
- Background: PubMed 29202966Donnez O, Roman H. Choosing the right surgical technique for deep endometriosis: shaving, disc excision, or bowel resection? Fertil Steril. 2017 Dec;108(6):931-942. doi: 10.1016/j.fertnstert.2017.09.006.
- Background: PubMed 31238150Abrao MS, Andres MP, Barbosa RN, Bassi MA, Kho RM. Optimizing Perioperative Outcomes with Selective Bowel Resection Following an Algorithm Based on Preoperative Imaging for Bowel Endometriosis. J Minim Invasive Gynecol. 2020 May-Jun;27(4):883-891. doi: 10.1016/j.jmig.2019.06.010. Epub 2019 Jun 22.
- Background: PubMed 32991006Puppo A, Olearo E, Gattolin A, Rimonda R, Novelli A, Ceccaroni M. Intraoperative Ultrasound for Bowel Deep Infiltrating Endometriosis: A Preliminary Report. J Ultrasound Med. 2021 Jul;40(7):1417-1425. doi: 10.1002/jum.15511. Epub 2020 Sep 29.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Infiltrating Endometriosis With or Without Bowel Involvement, run by Fundacion Dexeus at 1 site in Spain.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannick Hurni, MD (0034932274700, yanhur@dexeus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intraoperative ultrasound (time frame: Day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06876376, which also lists 10 linked publications.
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 30 Mar 2026.