EndometriosisINSIDENCT07517081
Intraoperative Sono-assessment In Deep Endometriosis
An observational study of Endometriosis and Endometriosis-related Pain, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Deep infiltrating endometriosis (DIE) involving the bowel, particularly the rectosigmoid region, is associated with significant gastrointestinal symptoms and impaired quality of life. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome
- How many people
- 57 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of women of reproductive age diagnosed with deep infiltrating endometriosis involving the rectum or sigmoid colon, with muscularis propria infiltration between 1 and 20 mm as assessed by expert preoperative transvaginal ultrasound. Eligible patients are those scheduled to undergo laparoscopic rectal shaving as part of standard clinical care at a tertiary referral center for endometriosis. All participants provide written informed consent prior to enrollment.
Who may be able to join
- Female patients aged 20-60 years
- Rectal or sigmoid nodule with muscularis propria infiltration ≥1 mm and <20 mm (assessed by expert transvaginal ultrasound)
- Indication for surgery agreed upon with the patient
- Written informed consent
Who cannot join
- Previous major bowel surgery or primary indication for bowel resection
- Inflammatory bowel disease, malignancy, or severe pelvic pathology
- Inability to complete study questionnaires
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: Intraoperative Ultrasound in Rectal Shaving for Deep Infiltrating Endometriosis: Evaluation of Residual Disease, Bowel Wall Thickness, and Clinical Outcomes
Deep infiltrating endometriosis (DIE) involving the bowel, particularly the rectosigmoid region, is associated with significant gastrointestinal symptoms and impaired quality of life. Rectal shaving is a conservative surgical technique aimed at removing endometriotic lesions while preserving bowel integrity; however, it may result in residual disease or excessive thinning of the bowel wall, potentially leading to recurrence or complications.
Intraoperative ultrasound (IOUS) allows real-time assessment of residual nodule thickness and bowel wall thickness after shaving. This prospective observational study aims to evaluate the relationship between intraoperative ultrasound measurements and postoperative clinical outcomes, including gastrointestinal symptoms and quality of life.
The study also seeks to identify ultrasound cut-off values that may guide intraoperative surgical decision-making and optimize the balance between radicality and safety.
Read the detailed description
Endometriosis affects approximately 7-10% of women of reproductive age and is frequently associated with delayed diagnosis. Deep infiltrating endometriosis involving the posterior compartment often causes gastrointestinal symptoms such as dyschezia, constipation, diarrhea, and rectal bleeding.
Surgical management of bowel DIE includes conservative approaches (rectal shaving) and radical procedures (disc excision or segmental resection). Current guidelines emphasize individualized treatment decisions.
Rectal shaving avoids bowel resection and is associated with lower morbidity but carries risks of residual disease and bowel wall thinning. Intraoperative ultrasound enables precise measurement of residual lesions and bowel wall thickness, potentially improving surgical outcomes.
This study evaluates whether:
- Greater residual nodule thickness is associated with persistent or recurrent symptoms;
- Reduced bowel wall thickness is associated with increased postoperative complications.
- Conditions
- Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome, Endometriosis, Rectum, Endometriosis of Colon
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptoms and Quality of Life Scores
Change in gastrointestinal symptom severity and quality of life (PAC-SYM and PAC-QOL scores) from baseline to 12 months, stratified by depth of muscular infiltration (1-6 mm, 7-12 mm, 13-20 mm)
Measured: 12 months
Secondary outcomes (2)
Association Between Residual Bowel Wall Thickness and Surgical Complications
Evaluation of the relationship between intraoperatively measured minimum residual bowel wall thickness at the site of rectal shaving and the occurrence of postoperative complications, including bowel perforation, rectovaginal fistula, anastomotic stenosis, and other complications.
Measured: 12 months
Identification of Predictive Ultrasound Cut-off Values
Identification of predictive cut-off values for intraoperative ultrasound parameters (e.g., residual nodule thickness, depth of infiltration, and bowel wall thickness) associated with postoperative outcomes and surgical complexity.
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
- 57 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
- NCT07517081
- Sponsor's protocol ID
- 27052
- Acronym
- INSIDE
- 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
- Intraoperative Ultrasound in Rectal Shaving for Deep Infiltrating Endometriosis: Evaluation of Residual Disease, Bowel Wall Thickness, and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07517081
- Acronym / sponsor ID
- INSIDE / 27052
- Conditions
- Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome, Endometriosis, Rectum, Endometriosis of Colon
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 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) involving the bowel, particularly the rectosigmoid region, is associated with significant gastrointestinal symptoms and impaired quality of life. Rectal shaving is a conservative surgical technique aimed at removing endometriotic lesions while preserving bowel integrity; however, it may result in residual disease or excessive thinning of the bowel wall, potentially leading to recurrence or complications.
Intraoperative ultrasound (IOUS) allows real-time assessment of residual nodule thickness and bowel wall thickness after shaving. This prospective observational study aims to evaluate the relationship between intraoperative ultrasound measurements and postoperative clinical outcomes, including gastrointestinal symptoms and quality of life.
The study also seeks to identify ultrasound cut-off values that may guide intraoperative surgical decision-making and optimize the balance between radicality and safety.
Detailed description
Endometriosis affects approximately 7-10% of women of reproductive age and is frequently associated with delayed diagnosis. Deep infiltrating endometriosis involving the posterior compartment often causes gastrointestinal symptoms such as dyschezia, constipation, diarrhea, and rectal bleeding.
Surgical management of bowel DIE includes conservative approaches (rectal shaving) and radical procedures (disc excision or segmental resection). Current guidelines emphasize individualized treatment decisions.
Rectal shaving avoids bowel resection and is associated with lower morbidity but carries risks of residual disease and bowel wall thinning. Intraoperative ultrasound enables precise measurement of residual lesions and bowel wall thickness, potentially improving surgical outcomes.
This study evaluates whether:
- Greater residual nodule thickness is associated with persistent or recurrent symptoms;
- Reduced bowel wall thickness is associated with increased postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of women of reproductive age diagnosed with deep infiltrating endometriosis involving the rectum or sigmoid colon, with muscularis propria infiltration between 1 and 20 mm as assessed by expert preoperative transvaginal ultrasound. Eligible patients are those scheduled to undergo laparoscopic rectal shaving as part of standard clinical care at a tertiary referral center for endometriosis. All participants provide written informed consent prior to enrollment.
Key inclusion criteria (4 listed)
- Female patients aged 20-60 years
- Rectal or sigmoid nodule with muscularis propria infiltration ≥1 mm and <20 mm (assessed by expert transvaginal ultrasound)
- Indication for surgery agreed upon with the patient
- Written informed consent
Key exclusion criteria (3 listed)
- Previous major bowel surgery or primary indication for bowel resection
- Inflammatory bowel disease, malignancy, or severe pelvic pathology
- Inability to complete study questionnaires
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
Change in Gastrointestinal Symptoms and Quality of Life Scores
Time frame: 12 months
Change in gastrointestinal symptom severity and quality of life (PAC-SYM and PAC-QOL scores) from baseline to 12 months, stratified by depth of muscular infiltration (1-6 mm, 7-12 mm, 13-20 mm)
2 secondary outcomes
Association Between Residual Bowel Wall Thickness and Surgical Complications
Time frame: 12 months
Identification of Predictive Ultrasound Cut-off Values
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-related Pain, 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 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: 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?
Change in Gastrointestinal Symptoms and Quality of Life Scores (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.