Clinical trial NCT06852248: Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery
Official 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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometriosis
Deep Endometriosis
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with deep endometriosis

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of eligible women
timeFrame: 24 months
measure: Proportion of eligible women agreeing to participate
timeFrame: 24 months
measure: Attrition rate in follow up process
timeFrame: 24 months
measure: Missing data in follow up process
timeFrame: 24 months
measure: Acceptability of the trial interventions and follow-up processes
timeFrame: 24 months
measure: Acceptability of the trial interventions and follow-up processes
timeFrame: 24 months
measure: Reasons for declining participation or withdrawal after agreeing to participate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
Study officials:
References: