Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery
NCT ID: NCT06852248
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2025-07-29
2028-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ureteric stenting
One group will have conventional ureteric stenting (temporary tubes placed in the ureters).
Ureteric stenting
The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will have conventional ureteric stenting (temporary tubes placed in the ureters)
Indocyanine green (ICG) dye
One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light.
Indocyanine green (ICG) dye
The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light.
Interventions
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Ureteric stenting
The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will have conventional ureteric stenting (temporary tubes placed in the ureters)
Indocyanine green (ICG) dye
The ICE trial is a pilot study involving two methods for identifying the ureters (tubes connecting the kidneys to the bladder) during endometriosis surgery. One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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University Hospitals of North Midlands NHS Trust
OTHER
Responsible Party
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Locations
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University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Aviva Ogbolosingha
Role: primary
Other Identifiers
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LPR 3359
Identifier Type: -
Identifier Source: org_study_id
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