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

Официальное название

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)

Обзор

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

Вмешательства

• Процедура Ureteric 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)
• Процедура Indocyanine 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.

Первичные конечные точки

• Number of eligible women [Срок оценки: 24 months]
• Proportion of eligible women agreeing to participate [Срок оценки: 24 months]
• Attrition rate in follow up process [Срок оценки: 24 months]
• Missing data in follow up process [Срок оценки: 24 months]
• Acceptability of the trial interventions and follow-up processes [Срок оценки: 24 months]
• Acceptability of the trial interventions and follow-up processes [Срок оценки: 24 months]
• Reasons for declining participation or withdrawal after agreeing to participate [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• University Hospitals of North Midlands NHS Trust — Stoke-on-Trent

Идентификаторы

NCT: NCT06852248 · LPR 3359

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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