NCT06852248 Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery
| NCT ID | NCT06852248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals of North Midlands NHS Trust |
| Condition | Endometriosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2025-07-29 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Endometriosis is a common (around 1 in 10 women), non-cancerous condition where tissue similar to the womb lining is found growing elsewhere, most commonly inside the pelvis. Symptoms vary but can include intense pelvic pain and infertility. Endometriosis that is very deep and painful may need surgery, which risks damage to the tubes that drain urine from the kidneys to the bladder (ureters). To reduce this risk, surgeons may put tiny plastic tubes called "stents" inside the ureters. These stents can stay for up-to 4 weeks following surgery but can cause severe pain and blood in the urine. Squirting a dye into the ureters, rather than using stents, may cause less pain for women after surgery whilst not making the removal of endometriosis worse, the operation take longer, or increasing the rates of complications (such as bleeding or damage to internal organs). Before a full clinical study can be run, the investigators need to understand whether this is possible, by doing a feasibility study
Eligibility Criteria
Inclusion Criteria: * Women aged 18 to 50 years * Scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis (DE) where ureteric stenting is planned. * Willing and able to provide consent for participation in the study Exclusion Criteria: * Confirmed or suspected pregnancy at the time of enrolment. * Suspicion or confirmation of malignancy. * History of ureteric injury from prior surgery or trauma * Medically unfit for surgery due to the following conditions: * Uncontrolled diabetes mellitus. * Severe Chronic Obstructive Pulmonary Disease (COPD). * Hypertrophic cardiomyopathy or significant cardiac conditions (e.g., recent myocardial infarction, aortic stenosis). * History of stroke or severe kyphoscoliosis. * Uncontrolled hypertension. * Body mass index (BMI): BMI greater than 45
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06852248 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06852248 currently recruiting?
Yes, NCT06852248 is actively recruiting participants. Contact the research team at aviva.ogbolosingha@uhnm.nhs.uk for enrollment information.
Where is the NCT06852248 trial being conducted?
This trial is being conducted at Stoke-on-Trent, United Kingdom.
Who is sponsoring the NCT06852248 clinical trial?
NCT06852248 is sponsored by University Hospitals of North Midlands NHS Trust. The trial plans to enroll 70 participants.