None listed
Conditions
Brief summary
Rationale: Ureteric injury is a known risk associated with complex gynecological surgery given its variable anatomical course through the pelvis. Ureteric injury is associated with significant morbidity thus methods to reduce surgical complications are important. Objectives: The primary objective is to determine the feasibility of undertaking a four-arm randomized trial to determine the most effective method of introducing cystoscopic-guided intraurethral indocyanine green (ICG) solution for ureteric identification during laparoscopic gynecological surgery. The intended primary outcome of the final study will be surgeon opinion of ease of ureteric identification laparoscopically. Secondary objectives include assessing if improved ureteric visualisation reduces surgical time, reduces additional procedures such as repeat cystoscopy or additional radiological investigations such as CT-IVP and reduces ureteric injury.
Interventions
25mg of Indocyanine Green (ICG) powder (one vial) will be diluted in 10mls of sterile water and 5mls injected into each ureter.
Patients will be divided into the following groups:
1. Cytoscopic-guided intraurethral ICG solution injected with advanced ureteric catheter at 3cm and remove ureteric catheter straightaway.
2. Cytoscopic-guided intraurethral ICG solution injected into ureter at 3cm with advanced ureteric catheter and insert ureteric catheter up to 17cm.
3. Cytoscopic-guided intraurethr
25mg of Indocyanine Green (ICG) powder (one vial) will be diluted in 10mls of sterile water and 5mls injected into each ureter. Patients will be divided into the following groups: 1. Cytoscopic-guided intraurethral ICG solution injected with advanced ureteric catheter at 3cm and remove ureteric catheter straightaway. 2. Cytoscopic-guided intraurethral ICG solution injected into ureter at 3cm with advanced ureteric catheter and insert ureteric catheter up to 17cm. 3. Cytoscopic-guided intraurethral ICG solution injected into ureter with advanced ureteric catheter at 10cm while withdrawing completely and removing it. 4. Cytoscopic-guided intraurethral ICG solution injected into ureter at 10 cm with advanced ureteric catheter while withdrawing then reinsert ureteric catheter at 17cm.
Sponsors
South Metropolitan Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All participants older or equal to 18 years of age planned to undergo gynecological laparoscopic surgery on the complex gynecology list at Fiona Stanley Hospital, Western Australia.
Exclusion criteria
Known allergy to iodides. Any of the following contraindications: lactating women, impaired renal or liver function. Non-English-speaking patients (due to the patient information only being available in English).
Outcome results
None listed