Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06852248

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Endometriosis Deep Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals of North Midlands NHS Trust

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

Location status: Recruiting

Location contact

Aviva Ogbolosingha

CONTACT

Gourab Misra

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Primary outcomes

  1. Number of eligible women

    Time frame: 24 months

    The number of eligible women across 2 UK sites that are suitable for trial recruitment

  2. Proportion of eligible women agreeing to participate

    Time frame: 24 months

    Number of women who are eligible that then take part in the trial

  3. Attrition rate in follow up process

    Time frame: 24 months

    Recording the percentage of people who drop out before the completion

  4. Missing data in follow up process

    Time frame: 24 months

    Recording how much data is missing from the follow up data

  5. Acceptability of the trial interventions and follow-up processes

    Time frame: 24 months

    Recording how acceptable surgeons find the trial interventions and follow up process.

  6. Acceptability of the trial interventions and follow-up processes

    Time frame: 24 months

    Recording how acceptable participants find the trial interventions and follow up process. This will be done using a focus group

  7. Reasons for declining participation or withdrawal after agreeing to participate

    Time frame: 24 months

    Recording the list of reasons people withdraw from the study or decline to take part

Study contacts

Contact information is provided by the study sponsor or research team.

Aviva Ogbolosingha

CONTACT

[email protected]

01782675380

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study 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)

Acronym: ICE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 28, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.