Deep Infiltrating Endometriosis (DIE)DIE IO TRUSNCT06776536
Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)
A study testing Transrectal ultrasound of the bowel endometriosis during operation in people with Deep Infiltrating Endometriosis (DIE) and Transrectal Ultrasound, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
we aim to evaluate the success of intraoperative transrectal ultrasound in measuring the depth and extent of bowel involvement in patients preoperatively diagnosed with intestinal endometriosis using transvaginal ultrasound and MRI, and who are planned for bowel resection Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Deep Infiltrating Endometriosis (DIE), Transrectal Ultrasound, Bowel Endometriosis
- What is being tested?
- Transrectal ultrasound of the bowel endometriosis during operation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2025to 7 Apr 2026
- Phase
- Interventional
- 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
Who may be able to join
- The study will include a minimum of 15 female patients aged 18-55 with bowel involvement due to deep infiltrative endometriosis, requiring bowel resection.
Who cannot join
- Patients with bowel endometriosis who does not require bowel resection, patients who have other bowel diseases, such as rectal tumors, Crohn's disease, or ulcerative colitis, will be excluded.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL
Istanbul, 34480
Baris Kaya, Associate Professor, +905323469156, mdbariskaya@gmail.com
Sercan Yuksel, Associate Professor, +9005057001666, drsercanyuksel@gmail.com
About this study
we aim to evaluate the success of intraoperative transrectal ultrasound in measuring the depth and extent of bowel involvement in patients preoperatively diagnosed with intestinal endometriosis using transvaginal ultrasound and MRI, and who are planned for bowel resection
Read the detailed description
This is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection.
Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results. Data will be analyzed using statistical methods, including sensitivity, specificity, and ROC curve analysis, to determine the diagnostic performance of TRUS.
The study will be conducted at Istanbul Başakşehir Çam and Sakura City Hospital, with multidisciplinary contributions from gynecology, radiology, and general surgery teams.
- Conditions
- Deep Infiltrating Endometriosis (DIE), Transrectal Ultrasound, Bowel Endometriosis, Bowel Resection
- Being tested
- Transrectal ultrasound of the bowel endometriosis during operation
- Keywords
- Deeply infiltrating endometriosis, bowel endometriosis, transrectal ultrasound, bowel resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transrectal ultrasound of the bowel endometriosis during operationDiagnostic test
This is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection.
Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating Endometriosis | Experimental | This study aims to investigate the feasibility of measuring the depth and extent of bowel involvement using intraoperative transrectal ultrasound in patients undergoing surgery for intestinal endometriosis Receives: Diagnostic Test: Transrectal ultrasound of the bowel endometriosis during operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative transrectal ultrasound of the rectal involvement of the deep infiltrating endometriosis will be compared with preoperative MRI
Patients diagnosed with rectal endometriosis and planned for bowel resection will undergo intraoperative transrectal ultrasound during laparoscopy. The transrectal ultrasound will be performed by a blinded radiologist, and the location, depth, and length of rectal involvement in DIE will be measured in millimeters using TRUS. These findings will be recorded. The results will be compared with preoperative MRI results which was performed by another radiologist for this study.
Measured: From enrollment to the 16 months
Secondary outcomes (1)
Demographic informations, patient characteristics, disease related pain scores, surgical informations
Patient demographic information, including age, BMI, known comorbidities, mode and number of deliveries, previous surgeries, and preoperative medical treatments, will be collected. Pain characteristics and visual analog score (VAS) scores for dysmenorrhea, dyspareunia, dysuria, dyschezia, and chronic pelvic pain will be retrieved from the hospital records or patient files. Surgical parameters, such as the type and duration of surgery will be recorded. Early postoperative complications will be recorded.
Measured: From enrollment to 16 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion7 Apr 2026 (estimated)
- Study completion7 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Deep Infiltrating Endometriosis (DIE)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Baris KAYA, Başakşehir Çam & Sakura City Hospital
- Investigators
- Baris Kaya, Associate Professor,MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776536
- Sponsor's protocol ID
- E-96317027-514.10-263823748
- Acronym
- DIE IO TRUS
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "IPD will not be shared due to concerns regarding patient confidentiality and privacy, as well as the sensitivity of the data related to rectal endometriosis and intraoperative findings.
Publications
Hardman D, Bennett R, Mikhail E. Laparoscopic shaving of rectosigmoid deep infiltrating endometriosis under laparoscopic ultrasound guidance. Fertil Steril. 2023 Jul;120(1):206-207. doi: 10.1016/j.fertnstert.2023.04.026. Epub 2023 Apr 26.
PubMed 37116640Hudelist G, Ballard K, English J, Wright J, Banerjee S, Mastoroudes H, Thomas A, Singer CF, Keckstein J. Transvaginal sonography vs. clinical examination in the preoperative diagnosis of deep infiltrating endometriosis. Ultrasound Obstet Gynecol. 2011 Apr;37(4):480-7. doi: 10.1002/uog.8935.
PubMed 21433168Griffiths A, Koutsouridou R, Vaughan S, Penketh R, Roberts SA, Torkington J. Transrectal ultrasound and the diagnosis of rectovaginal endometriosis: a prospective observational study. Acta Obstet Gynecol Scand. 2008;87(4):445-8. doi: 10.1080/00016340801948318.
PubMed 18382872Doniec JM, Kahlke V, Peetz F, Schniewind B, Mundhenke C, Lohnert MS, Kremer B. Rectal endometriosis: high sensitivity and specificity of endorectal ultrasound with an impact for the operative management. Dis Colon Rectum. 2003 Dec;46(12):1667-73. doi: 10.1007/BF02660773.
PubMed 14668593Roman H, Kouteich K, Gromez A, Hochain P, Resch B, Marpeau L. Endorectal ultrasound accuracy in the diagnosis of rectal endometriosis infiltration depth. Fertil Steril. 2008 Oct;90(4):1008-13. doi: 10.1016/j.fertnstert.2007.07.1361. Epub 2007 Nov 26.
PubMed 18023444
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)
- ClinicalTrials.gov ID
- NCT06776536
- Acronym / sponsor ID
- DIE IO TRUS / E-96317027-514.10-263823748
- Conditions
- Deep Infiltrating Endometriosis (DIE), Transrectal Ultrasound, Bowel Endometriosis, Bowel Resection
- Keywords
- Deeply infiltrating endometriosis, bowel endometriosis, transrectal ultrasound, bowel resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 7 Apr 2026 (estimated)
- Study completion
- 7 Apr 2026 (estimated)
- First posted
- 15 Jan 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.
we aim to evaluate the success of intraoperative transrectal ultrasound in measuring the depth and extent of bowel involvement in patients preoperatively diagnosed with intestinal endometriosis using transvaginal ultrasound and MRI, and who are planned for bowel resection
Detailed description
This is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection.
Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results. Data will be analyzed using statistical methods, including sensitivity, specificity, and ROC curve analysis, to determine the diagnostic performance of TRUS.
The study will be conducted at Istanbul Başakşehir Çam and Sakura City Hospital, with multidisciplinary contributions from gynecology, radiology, and general surgery teams.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating Endometriosis | Experimental | Diagnostic Test: Transrectal ultrasound of the bowel endometriosis during operationThis study aims to investigate the feasibility of measuring the depth and extent of bowel involvement using intraoperative transrectal ultrasound in patients undergoing surgery for intestinal endometriosis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will include a minimum of 15 female patients aged 18-55 with bowel involvement due to deep infiltrative endometriosis, requiring bowel resection.
Key exclusion criteria (2 listed)
- Patients with bowel endometriosis who does not require bowel resection, patients who have other bowel diseases, such as rectal tumors, Crohn's disease, or ulcerative colitis, will be excluded.
- -
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 |
|---|---|---|
| Transrectal ultrasound of the bowel endometriosis during operationThis is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection. Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results. | Diagnostic test | Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating Endometriosis |
Primary outcome
Intraoperative transrectal ultrasound of the rectal involvement of the deep infiltrating endometriosis will be compared with preoperative MRI
Time frame: From enrollment to the 16 months
Patients diagnosed with rectal endometriosis and planned for bowel resection will undergo intraoperative transrectal ultrasound during laparoscopy. The transrectal ultrasound will be performed by a blinded radiologist, and the location, depth, and length of rectal involvement in DIE will be measured in millimeters using TRUS. These findings will be recorded. The results will be compared with preoperative MRI results which was performed by another radiologist for this study.
1 secondary outcome
Demographic informations, patient characteristics, disease related pain scores, surgical informations
Time frame: From enrollment to 16 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 15 Jan 2025.
- Results publication: PubMed 37116640Hardman D, Bennett R, Mikhail E. Laparoscopic shaving of rectosigmoid deep infiltrating endometriosis under laparoscopic ultrasound guidance. Fertil Steril. 2023 Jul;120(1):206-207. doi: 10.1016/j.fertnstert.2023.04.026. Epub 2023 Apr 26.
- Results publication: PubMed 21433168Hudelist G, Ballard K, English J, Wright J, Banerjee S, Mastoroudes H, Thomas A, Singer CF, Keckstein J. Transvaginal sonography vs. clinical examination in the preoperative diagnosis of deep infiltrating endometriosis. Ultrasound Obstet Gynecol. 2011 Apr;37(4):480-7. doi: 10.1002/uog.8935.
- Results publication: PubMed 18382872Griffiths A, Koutsouridou R, Vaughan S, Penketh R, Roberts SA, Torkington J. Transrectal ultrasound and the diagnosis of rectovaginal endometriosis: a prospective observational study. Acta Obstet Gynecol Scand. 2008;87(4):445-8. doi: 10.1080/00016340801948318.
- Results publication: PubMed 14668593Doniec JM, Kahlke V, Peetz F, Schniewind B, Mundhenke C, Lohnert MS, Kremer B. Rectal endometriosis: high sensitivity and specificity of endorectal ultrasound with an impact for the operative management. Dis Colon Rectum. 2003 Dec;46(12):1667-73. doi: 10.1007/BF02660773.
- Results publication: PubMed 18023444Roman H, Kouteich K, Gromez A, Hochain P, Resch B, Marpeau L. Endorectal ultrasound accuracy in the diagnosis of rectal endometriosis infiltration depth. Fertil Steril. 2008 Oct;90(4):1008-13. doi: 10.1016/j.fertnstert.2007.07.1361. Epub 2007 Nov 26.
- The European Endometriosis League (EEL) h The aim is to extend public awareness and support scientific research in the field of EndometriosisLink provided by the sponsor.
- Individual participant dataSharing planned: No. "IPD will not be shared due to concerns regarding patient confidentiality and privacy, as well as the sensitivity of the data related to rectal endometriosis and intraoperative findings.
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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.
Baris Kaya, Associate Professor,MD principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transrectal ultrasound of the bowel endometriosis during operation in people with Deep Infiltrating Endometriosis (DIE) and Transrectal Ultrasound, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 15 Jan 2025. 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 Turkey (Türkiye). 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 Baris Kaya, Associate Professor (+905323469156, mdbariskaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative transrectal ultrasound of the rectal involvement of the deep infiltrating endometriosis will be compared with preoperative MRI (time frame: From enrollment to the 16 months). 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 NCT06776536, which also lists 5 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 15 Jan 2025.