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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Deep Endometriosis
• Intervention / Treatment: Procedure: Ureteric stenting; Procedure: Indocyanine green (ICG) dye

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Aviva Ogbolosingha; Phone Number: 01782675380; Email: aviva.ogbolosingha@uhnm.nhs.uk

Study Locations

• United Kingdom
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • Recruiting
      • University Hospitals of North Midlands NHS Trust
      • Contact: Aviva Ogbolosingha
      • Principal Investigator: Gourab Misra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with deep endometriosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ureteric stenting; One group will have conventional ureteric stenting (temporary tubes placed in the ureters).	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)
Indocyanine green (ICG) dye; One group will receive indocyanine green (ICG) dye injected into the ureters to make them visible under a special light.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eligible women	The number of eligible women across 2 UK sites that are suitable for trial recruitment	24 months
Proportion of eligible women agreeing to participate	Number of women who are eligible that then take part in the trial	24 months
Attrition rate in follow up process	Recording the percentage of people who drop out before the completion	24 months
Missing data in follow up process	Recording how much data is missing from the follow up data	24 months
Acceptability of the trial interventions and follow-up processes	Recording how acceptable surgeons find the trial interventions and follow up process.	24 months
Acceptability of the trial interventions and follow-up processes	Recording how acceptable participants find the trial interventions and follow up process. This will be done using a focus group	24 months
Reasons for declining participation or withdrawal after agreeing to participate	Recording the list of reasons people withdraw from the study or decline to take part	24 months

Collaborators and Investigators

• Sponsor: University Hospitals of North Midlands NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chemical Actions and Uses; Indoles; Specialty Uses of Chemicals; Indocyanine Green; Coloring Agents
• Other Study ID Numbers: LPR 3359

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No