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NCT06852248 | NOT YET RECRUITING | Endometriosis

Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery
Sponsor:

University Hospitals of North Midlands NHS Trust

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

Condition or disease

Endometriosis

Deep Endometriosis

Intervention/treatment

Ureteric stenting

Indocyanine green (ICG) dye

Study Type : OBSERVATIONAL
Estimated Enrollment : 70 participants
Official Title : 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)
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2027-03
Estimated Study Completion Date : 2028-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery

Location Details

NCT06852248

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How to Participate

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Locations

Not yet recruiting

United Kingdom, Staffordshire

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG