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Recruiting NCT06852248

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

— Observational Endometriosis Deep Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ureteric stenting, Indocyanine green (ICG) dye.
Who it may be relevant to
Registry conditions: Endometriosis, Deep Endometriosis. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

Interventions

  • Procedure 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)
  • Procedure 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.

Primary outcome measures

  • Number of eligible women [Time frame: 24 months]
  • Proportion of eligible women agreeing to participate [Time frame: 24 months]
  • Attrition rate in follow up process [Time frame: 24 months]
  • Missing data in follow up process [Time frame: 24 months]
  • Acceptability of the trial interventions and follow-up processes [Time frame: 24 months]
  • Acceptability of the trial interventions and follow-up processes [Time frame: 24 months]
  • Reasons for declining participation or withdrawal after agreeing to participate [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • University Hospitals of North Midlands NHS Trust — Stoke-on-Trent

Identifiers

NCT: NCT06852248 · LPR 3359

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗