ICE trial

• Research type

  Research Study

• Full title

  A pilot study to evaluate the feasibility of a future trial comparing major complications and postoperative pain after ureteric catheterisation and retrograde injection of indocyanine green (ICG) against ureteric stenting during laparoscopic surgery for deep endometriosis.

• IRAS ID

  332857

• Contact name

  Gourab Misra

• Contact email

  gourab.misra@uhnm.nhs.uk

• Sponsor organisation

  University Hospitals of North Midlands NHS Trust

• Duration of Study in the UK

  2 years, 0 months, 13 days

• Research summary

  Endometriosis is a common 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 we can
  run a full clinical study, we need to understand whether this is possible, by doing a pilot study
  

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  25/NW/0075

• Date of REC Opinion

  17 Apr 2025

• REC opinion

  Further Information Favourable Opinion