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Trial registered on ANZCTR


Registration number
ACTRN12624000831583
Ethics application status
Approved
Date submitted
9/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of indocyanine green in ureteric identification in Gynaecological Surgery
Scientific title
Indocyanine green for ureteric identification in complex gynaecology surgery: A single centered, randomised, double-blinded feasibility study in women planned to undergo complex gynaecological laparoscopic surgery
Secondary ID [1] 312302 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 334039 0
Peritoneal fibrosis 334041 0
Adenomyosis 334042 0
Leiomyoma 334043 0
Condition category
Condition code
Surgery 330712 330712 0 0
Surgical techniques
Reproductive Health and Childbirth 330852 330852 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328772 0
Early detection / Screening
Intervention code [2] 328773 0
Prevention
Intervention code [3] 328774 0
Treatment: Surgery
Comparator / control treatment
2. Cytoscopic-guided intraurethral ICG solution injected into ureter at 3cm with advanced ureteric catheter and insert ureteric catheter up to 17cm.
Control group
Active

Outcomes
Primary outcome [1] 338471 0
To determine the feasibility of a larger randomized, controlled trial to investigate the effectivity of four methods of administering cystoscopic-guided intraurethral ICG solution for ureteric identification during operative gynecological laparoscopy.
Timepoint [1] 338471 0
1. surgeon opinion of cystoscopic- guided intraurethral injection method during and at the end of the surgery
2. recruitment target after baseline
3. time to complete recruitment
4. study procedure process complications during surgery and during hospital admission
5. participant acceptability of study during recruitment and end of the study
6. costing throughout the study
Secondary outcome [1] 436070 0
To determine the effectiveness of the four administration methods in visualising the ureters intra-operatively
Timepoint [1] 436070 0
During surgery
Secondary outcome [2] 436071 0
To determine if ureteric ICG alters surgical time
Timepoint [2] 436071 0
During surgery
Secondary outcome [3] 436072 0
To determine change in the number of additional procedures such as repeat cystoscopy or imaging
Timepoint [3] 436072 0
During surgery and post-procedure during hospital admission
Secondary outcome [4] 436073 0
To determine if intraurethral ICG results in a change ureteric injury rates.
Timepoint [4] 436073 0
Intra-operative and post-operative up to 6 weeks to allow late diagnosis of potential ureteric injury
Secondary outcome [5] 436074 0
To determine if intraurethral ICG results in acute kidney injury (AKI)
Timepoint [5] 436074 0
Post-operatively Day 1

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed envelope (SNOSE) technique will be utilised. The randomisation group will be written on a paper and kept in an opaque sealed envelope. The primary investigator will open the sealed envelope once the patient has consented to participate and then assigns the treatment group accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised into equal allocation of 5 patients per group using a computer-generated random allocation key sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed with the intent-to-treat principle and per protocol analysis. As this is a feasibility study, no statistical analysis will occur between the intervention groups. The mean scores on the Likert scale will be presented, as will the mean surgical time. Complications will be presented descriptively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26741 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42789 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 316694 0
Government body
Name [1] 316694 0
South Metropolitan Health Services
Country [1] 316694 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Services
Address
Country
Australia
Secondary sponsor category [1] 318894 0
None
Name [1] 318894 0
Address [1] 318894 0
Country [1] 318894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315473 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315473 0
https://smhs.health.wa.gov.au/Our-research/For-researchers
Ethics committee country [1] 315473 0
Australia
Date submitted for ethics approval [1] 315473 0
30/12/2023
Approval date [1] 315473 0
17/04/2024
Ethics approval number [1] 315473 0
RGS0000006458

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134802 0
Dr Vinita Rajadurai
Address 134802 0
Obstetrics and Gynaecology Department, Fiona Stanley Hospital, 11 Warren Drive, Murdoch 6150 Western Australia
Country 134802 0
Australia
Phone 134802 0
+61452486774
Fax 134802 0
Email 134802 0
[email protected]
Contact person for public queries
Name 134803 0
Vinita Rajadurai
Address 134803 0
Obstetrics and Gynaecology Department, Fiona Stanley Hospital, 11 Warren Drive, Murdoch 6150 Western Australia
Country 134803 0
Australia
Phone 134803 0
+61452486774
Fax 134803 0
Email 134803 0
[email protected]
Contact person for scientific queries
Name 134804 0
Vinita Rajadurai
Address 134804 0
Obstetrics and Gynaecology Department, Fiona Stanley Hospital, 11 Warren Drive, Murdoch 6150 Western Australia
Country 134804 0
Australia
Phone 134804 0
+61 861522222
Fax 134804 0
Email 134804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.