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.
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
- Conditions the study is for
- Endometriosis, Endometriosis of Colon, Endometriosis; Bowel
- 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.
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)
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
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
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.
- First posted8 Apr 2026
- Study start7 Apr 2026 (estimated)
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgia Gaia, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Transvaginal and Intraoperative Ultrasound in Rectosigmoid Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT07517055
- Acronym / sponsor ID
- INTREND / 27029
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Jul 2028 (estimated)
- First posted
- 8 Apr 2026 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement Between TVUS and IO-US Measurements
Time frame: 12 months
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).
3 secondary outcomes
Measurement Difference Between TVUS and IO-US
Time frame: 12 months
Agreement Analysis Between TVUS and IO-US
Time frame: 12 months
Intraobserver and Interobserver Reproducibility
Time frame: 12 months
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 8 Apr 2026.
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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.
Giorgia Gaia principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.