Actively Recruiting

Age: 18Years - 50Years
FEMALE
NCT06852248

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

Led by University Hospitals of North Midlands NHS Trust · Updated on 2025-09-03

70

Participants Needed

1

Research Sites

135 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 50 years
  • Scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis where ureteric stenting is planned
  • Willing and able to provide consent for participation in the study
Not Eligible

You will not qualify if you...

  • 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 uncontrolled diabetes mellitus
  • Medically unfit for surgery due to severe Chronic Obstructive Pulmonary Disease (COPD)
  • Medically unfit for surgery due to hypertrophic cardiomyopathy or significant cardiac conditions such as recent myocardial infarction or aortic stenosis
  • Medically unfit for surgery due to history of stroke or severe kyphoscoliosis
  • Medically unfit for surgery due to uncontrolled hypertension
  • Body mass index (BMI) greater than 45

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals of North Midlands NHS Trust

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

Actively Recruiting

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Research Team

A

Aviva Ogbolosingha

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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