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

NCT06852248 | Recruiting

• 1 other identifier: LPR 3359
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Endometriosis; Deep Endometriosis

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Ureteric stenting

One group will have conventional ureteric stenting (temporary tubes placed in the ureters).

Procedure: Ureteric stenting

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

Interventions

Ureteric stenting PROCEDURE

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)

Ureteric stenting

Indocyanine green (ICG) dye PROCEDURE

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.

Indocyanine green (ICG) dye

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with deep endometriosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

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

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Indocyanine Green; Coloring Agents

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Specialty Uses of Chemicals; Chemical Actions and Uses

Central Study Contacts

Aviva Ogbolosingha

CONTACT

01782675380; aviva.ogbolosingha@uhnm.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 28, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

GB (1)