AzTrials
AzTrials

EndometriosisINTRENDNCT07517055

Intraoperative vs Transvaginal Ultrasound in Rectosigmoid Endometriosis

An observational study of Endometriosis and Endometriosis of Colon, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Deep infiltrating endometriosis (DIE) of the rectum and rectosigmoid colon represents one of the most severe forms of endometriosis and often requires surgical management when symptomatic and unresponsive to medical therapy. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
How many people
98 participants
Where
No sites listed yet
Study dates
7 Apr 2026to 7 Jul 2028
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 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women with suspected deep infiltrating endometriosis of the posterior compartment involving the rectum or rectosigmoid colon who are scheduled for surgical treatment.

Who may be able to join

  • Women aged 18 to 55 years
  • Clinical and/or imaging suspicion of rectal or rectosigmoid deep infiltrating endometriosis (DIE)
  • Indication for laparoscopic or robotic surgery for DIE
  • Ability and willingness to provide written informed consent

Who cannot join

  • Previous bowel resection for deep infiltrating endometriosis
  • Active inflammatory bowel disease
  • Pregnancy
  • Technical inability to perform transvaginal or intraoperative ultrasound
  • Refusal or withdrawal of informed consent

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Comparative Study of Transvaginal and Intraoperative Ultrasound in Rectosigmoid Deep Infiltrating Endometriosis

Deep infiltrating endometriosis (DIE) of the rectum and rectosigmoid colon represents one of the most severe forms of endometriosis and often requires surgical management when symptomatic and unresponsive to medical therapy. Accurate preoperative assessment of lesion size, extent, and depth of bowel infiltration is essential to guide surgical planning and minimize complications. Transvaginal ultrasound (TVUS) is the first-line imaging technique for the diagnosis of pelvic endometriosis and has high diagnostic accuracy for detecting rectosigmoid lesions. However, its ability to precisely assess infiltration depth and guide the choice of surgical technique may be limited by anatomical distortion and technical factors. Intraoperative ultrasound (IO-US) is a real-time imaging modality that can be performed during laparoscopic surgery after adhesiolysis, allowing direct evaluation of bowel lesions. It may improve the assessment of lesion characteristics and support intraoperative decision-making, potentially reducing unnecessary bowel resections. This prospective single-center comparative study aims to evaluate the agreement between preoperative TVUS and intraoperative ultrasound in measuring rectal and rectosigmoid DIE nodules. Secondary objectives include assessing measurement differences, identifying factors associated with discordance, and evaluating the reproducibility of ultrasound measurements. The findings of this study may improve preoperative counseling, optimize surgical planning, and support the integration of intraoperative ultrasound into the management of bowel endometriosis.

Read the detailed description

Deep infiltrating endometriosis (DIE) is defined as endometriotic lesions penetrating at least 5 mm beneath the peritoneal surface and represents the most severe form of the disease. Bowel involvement occurs in a significant proportion of cases, with the rectum and rectosigmoid junction being affected in up to 70-90% of intestinal localizations. Patients commonly present with gastrointestinal symptoms such as dyschezia, tenesmus, constipation, or obstructive symptoms, which may significantly impair quality of life.

Surgical management is indicated in patients with severe symptoms or failure of medical therapy. In this setting, accurate preoperative evaluation of lesion size, number, circumferential involvement, and depth of bowel wall infiltration is crucial to guide surgical planning and to select the most appropriate technique (e.g., shaving, discoid excision, or segmental resection). An optimal balance between radical excision and functional preservation is essential to minimize postoperative complications and long-term functional sequelae. Transvaginal ultrasound (TVUS) is currently considered the first-line imaging modality for the diagnosis of pelvic endometriosis. When performed by experienced operators following standardized protocols, TVUS demonstrates high sensitivity and specificity for detecting rectosigmoid DIE. However, its ability to accurately assess the depth of muscular infiltration and to predict the most appropriate surgical approach may be limited by acoustic shadowing, reduced rectal distension, anatomical distortion due to adhesions, and operator dependency.

Intraoperative ultrasound (IO-US) is a real-time imaging technique performed during laparoscopic surgery using probes compatible with standard trocars. Following adhesiolysis and mobilization of the affected bowel segment, IO-US allows direct application of the probe to the lesion, enabling a more precise evaluation of lesion size, number, circumferential involvement, and depth of infiltration. This technique has been widely used in other surgical fields, such as hepatic and renal surgery, and may provide additional information to guide intraoperative decision-making in endometriosis surgery.

Preliminary evidence suggests that IO-US may improve the accuracy of lesion assessment and may influence surgical strategy; however, current data are limited and derived from small series. In particular, the agreement between preoperative TVUS and IO-US in the evaluation of rectal and rectosigmoid DIE has not been systematically investigated. This prospective, single-center, observational comparative study is designed to assess the agreement between preoperative TVUS and IO-US measurements in the same patients using paired data. Each participant will undergo standard preoperative TVUS and intraoperative ultrasound following adhesiolysis. In both assessments, lesion dimensions (craniocaudal and laterolateral diameters), depth of infiltration, and percentage of bowel circumference involved will be recorded.

By directly comparing preoperative and intraoperative ultrasound findings, this study aims to clarify the potential added value of IO-US in the surgical management of rectosigmoid endometriosis. The results may contribute to improving preoperative counseling, refining surgical planning, and optimizing the balance between radicality and functional preservation in patients undergoing surgery for bowel endometriosis.

Medical subject headings
Endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement Between TVUS and IO-US Measurements

    Agreement between preoperative transvaginal ultrasound (TVUS) and intraoperative ultrasound (IO-US) in measuring rectal and rectosigmoid deep infiltrating endometriosis nodules, assessed using the intraclass correlation coefficient (ICC).

    Measured: 12 months

Secondary outcomes (3)
  1. Measurement Difference Between TVUS and IO-US

    Mean and absolute differences between lesion measurements obtained by TVUS and IO-US (craniocaudal diameter, laterolateral diameter, depth of infiltration, and percentage of bowel circumference involvement).

    Measured: 12 months

  2. Agreement Analysis Between TVUS and IO-US

    Assessment of agreement between TVUS and IO-US measurements using Bland-Altman plots, including bias and limits of agreement.

    Measured: 12 months

  3. Intraobserver and Interobserver Reproducibility

    Assessment of reproducibility of ultrasound measurements using intraclass correlation coefficient (ICC) for intra- and interobserver variability.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start7 Apr 2026 (estimated)
  3. Primary completion7 Apr 2027 (estimated)
  4. Study completion7 Jul 2028 (estimated)

Resources

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
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07517055
Sponsor's protocol ID
27029
Acronym
INTREND
Status last verified
Mar 2026
First submitted
1 Apr 2026
Last updated
8 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Endometriosis of Colon, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

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 5 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: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Giorgia Gaia (+393384406299, giorgia.gaia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement Between TVUS and IO-US Measurements (time frame: 12 months). 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 8 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in