Deep Endometriosis, Endometriosis
Conditions
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
Interventions
PROCEDUREUreteric stenting
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)
PROCEDUREIndocyanine green (ICG) dye
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.
Sponsors
University Hospitals of North Midlands NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of eligible women | 24 months | The number of eligible women across 2 UK sites that are suitable for trial recruitment |
| Proportion of eligible women agreeing to participate | 24 months | Number of women who are eligible that then take part in the trial |
| 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 |
| Acceptability of the trial interventions and follow-up processes | 24 months | Recording how acceptable surgeons find the trial interventions and follow up process. |
| 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 |
Countries
United Kingdom
Contacts
Primary ContactAviva Ogbolosingha
Outcome results
None listed