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

University Hospitals of North Midlands NHS Trust70 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Endometriosis Deep Endometriosis

Interventions

Ureteric stenting

Indocyanine green (ICG) dyePROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of eligible women

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

Time frame: 24 months

Proportion of eligible women agreeing to participate

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

Time frame: 24 months

Attrition rate in follow up process

Recording the percentage of people who drop out before the completion

Time frame: 24 months

Missing data in follow up process

Recording how much data is missing from the follow up data

Time frame: 24 months

Acceptability of the trial interventions and follow-up processes

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

Time frame: 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

Time frame: 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

Time frame: 24 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts