Validation of ICG to identify the urethra during rectal surgery
Research type
Research Study
Full title
Validation of ICG to identify the urethra during rectal surgery
IRAS ID
226891
Contact name
Christopher Cunningham
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 18 months, 0 days
Research summary
During certain types of surgery on the rectum there is a risk of injuring the urethra (tube which transports urine from the bladder to outside of the body). We have performed a study on human cadavers that shows that using ICG fluorescence may help the surgeon identify the location of the urethra and therefore protect it.
ICG (indocyanine green) is a fluorescent drug that is widely used in surgery. It is a safe drug and has no active component to it.
This is a feasibility study where the primary objective is to assess the feasibility of using ICG to fluoresce the urethra during surgery.
Patients undergoing rectal surgery will be eligible and the study will be conducted in Oxford University Hospitals. During their operation under general anaesthetic, ICG mixed with a lubricant gel (instillagel) will be infiltrated directly into the urethra. Our fluorescence enabled camera will then attempt to visualise the fluorescence and locate the position of the urethra. At the end of the operation we will wash the urethra with normal saline. At 30-days we will review the medical notes and assess for any adverse events relating to the ICG.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0299
Date of REC Opinion
20 Jun 2017
REC opinion
Favourable Opinion