Urethra Injury, Rectal Cancer, Surgery
Conditions
Keywords
Fluorescence
Brief summary
This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.
Interventions
Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant
Sponsors
University of Oxford
Oxford University Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study. * Male, aged 18 years or above. * Undergoing low rectal surgery where the operating field will be close to the urethra
Exclusion criteria
* Participant has an allergy to iodine or ICG * Known liver failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of urethras identified under white light and fluorescence | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Signal to background ratios between cohorts of patients with varying doses of ICG | 1 day |
| Subjective assessment of usefulness of technology during operative procedure | 1 day |
| Length of time of interruption in operative procedure to perform trial intervention | 1 day |
| Number of adverse events related to trial intervention | 30 days |
Countries
United Kingdom
Outcome results
None listed