Identifying ureters during deep endometriosis surgery using indocyanine green dye instead of ureteric stents
Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery: A Pilot Trial (ICE Trial)
This project will see if injecting indocyanine green dye into the ureters causes less postoperative pain than placing ureteric stents for women aged 18–50 undergoing laparoscopic or robotic surgery for deep endometriosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospitals of North Midlands NHS Trust Academic / other |
| Locations | 1 site (Stoke-on-Trent, Staffordshire) |
| Trial ID | NCT06852248 on ClinicalTrials.gov |
What this trial studies
Surgeons often place temporary ureteric stents during excision of deep endometriosis to reduce the risk of ureteric injury, but stents can cause significant pain and blood in the urine. This observational feasibility project compares conventional ureteric stenting with injection of indocyanine green (ICG) dye to make ureters visible under near-infrared imaging. Investigators will record perioperative outcomes including postoperative pain, urinary symptoms, operative time, and surgical complications to determine whether the dye approach appears safe and acceptable. Results will be used to decide if a larger randomized trial is warranted.
Who should consider this trial
Good fit: Women aged 18–50 scheduled for laparoscopic or robotic excision of deep endometriosis where ureteric stenting is planned and who are able to give informed consent.
Not a fit: People who are pregnant, have suspected malignancy, prior ureteric injury, are medically unfit for surgery, or have a BMI over 45 are excluded and unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this technique could reduce stent-related pain and urinary symptoms after deep endometriosis surgery while keeping similar safety and surgical outcomes.
How similar studies have performed: Small surgical series and case reports have shown ICG can reliably highlight ureters and suggest fewer stent-related symptoms, but randomized or large comparative evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stoke-on-Trent, Staffordshire
- University Hospitals of North Midlands NHS Trust — Stoke-on-Trent, Staffordshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Aviva Ogbolosingha
- Email: aviva.ogbolosingha@uhnm.nhs.uk
- Phone: 01782675380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.