NCT06876376

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2025Jun 2027

Study Start

First participant enrolled

January 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 10, 2025

Last Update Submit

March 25, 2026

Conditions

Deep Infiltrating Endometriosis With or Without Bowel Involvement

Keywords

EndometriosisIntraoperative UltrasoundUltrasoundsurgeryminimally invasive surgery

Outcome Measures

Primary Outcomes (2)

  • Feasibility of intraoperative ultrasound

    o The proportion of patients in whom intraoperative ultrasound techniques can successfully identify rectal or rectosigmoid junction deep infiltrating endometriosis nodules during surgery.

    Day of surgery

  • Accuracy of intraoperative ultrasound

    o Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.

    Day of surgery

Secondary Outcomes (3)

  • Impact on Surgical Decision-Making

    Day of surgery

  • Postoperative Pain and Function

    at 3-months, 6-months and 12-months follow-up

  • Complication Rates

    From day of surgery to 7 days later

Study Arms (1)

posterior compartment deep infiltrating endometriosis

Procedure: intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis

Interventions

intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosisPROCEDURE

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.

posterior compartment deep infiltrating endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Planned surgery for diagnostic purposes only.
  • Pregnancy at the time of enrollment.
  • Poor understanding of Spanish or English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

RECRUITING

Related Publications (10)

  • Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.

    PMID: 15541453BACKGROUND

  • Berkley KJ, Rapkin AJ, Papka RE. The pains of endometriosis. Science. 2005 Jun 10;308(5728):1587-9. doi: 10.1126/science.1111445.

    PMID: 15947176BACKGROUND

  • de 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.

    PMID: 20801404BACKGROUND

  • Nnoaham 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.

    PMID: 21718982BACKGROUND

  • Vercellini 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.

    PMID: 24366116BACKGROUND

  • Chapron 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.

    PMID: 16543256BACKGROUND

  • Scioscia 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.

    PMID: 21241258BACKGROUND

  • Donnez 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.

    PMID: 29202966BACKGROUND

  • Abrao 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.

    PMID: 31238150BACKGROUND

  • Puppo 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.

    PMID: 32991006BACKGROUND

Related Links

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Yannick Hurni, MD

CONTACT

0034932274700yanhur@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700nacrod@dexeus.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

January 20, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

ES(1)