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

Not yet recruiting

• Conditions: Endometriosis; Deep Endometriosis

• Registration Number: NCT06852248
• Lead Sponsor: University Hospitals of North Midlands NHS Trust

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Start: 2025-05
• Primary Completion: 2027-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, Staffordshire, United Kingdom