Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000146897
Ethics application status
Approved
Date submitted
9/11/2020
Date registered
12/02/2021
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
TISSEEL (Fibrin Sealant) for Vaginal Vault Haematoma
Scientific title
Evaluation of the effect of TISSEEL (Fibrin Sealant) on incidence of vaginal vault haematoma post total laparoscopic hysterectomy
Secondary ID [1] 302740 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal Vault Haematoma 319672 0
Hysterectomy 319673 0
Condition category
Condition code
Surgery 317601 317601 0 0
Other surgery
Reproductive Health and Childbirth 317940 317940 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TISSEEL (Fibrin sealant) will be used in participants who undergo total laparoscopic hysterectomy with no indication or concern of bleeding post suture of vaginal vault. After suturing of the vaginal vault, with patient still anaesthetised and laparoscopic ports still in situ,
a consultant gynaecologist will apply the TISSEEL topically to the vaginal vault suture. Enough TISSEEL will be applied as is sufficient to entirely cover the suture area. TISSEEL will only be applied once per patient. Applying TISSEEL takes about 30-60 secondss, then requires a 2 minute wait (to check haemostasis +/- perform salpingectomy during this time). Patients who consent to the study and undergo intervention will have procedure notes entered into the electronic medical record that will be accessible to the study team for analysis.
Intervention code [1] 319019 0
Treatment: Devices
Comparator / control treatment
Standard of Care. Participants randomised to the control group who undergo total laparoscopic hysterectomy with no indication or concern of bleeding post suture of vaginal vault will receive standard of care. A consultant gynaecologist will suture the vaginal vault without any fibrin sealant.
Control group
Active

Outcomes
Primary outcome [1] 325649 0
The rate of sonographically proven vaginal vault haemotoma following a total laparoscopic hysterectomy with and without the use of TISSEEL. Participants will be invited to attend a free ultrasound. The presence and dimensions of any vault collection reported on the ultrasound summary will be recorded.
Timepoint [1] 325649 0
12-14 days post hysterectomy
Secondary outcome [1] 388671 0
This is a composite outcome. The rate of complications associated with a vaginal vault haematoma post-TLH within 6 weeks including: gynaecology re-admission, blood transfusion, vault infection requiring antibiotics, and/or return to theatre. The patient’s hospital records will be reviewed to look for any presentation to the Emergency Department with any complications within the 6 weeks post-operatively. The patient will be called at 6 weeks post-operation and a unvalidated tick box questionnaire completed over the phone.
Timepoint [1] 388671 0
Up to 6 weeks post hysterectomy

Eligibility
Key inclusion criteria
1) Females
2) 18 years old and over
3) Undergoing a Total Laparoscopic Hysterectomy for benign pathology at Gold Coast University Hospital
4) Operational consultant listed as Dr Walker
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Previous or concurrent diagnosis of malignancy
2) Known coagulopathy
3) Known allergy to TISSEEL excipients
4) Concurrent use of alternative haemostatic agents other than TISSEEL during operation

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
4/01/2023
Actual
Date of last data collection
Anticipated
15/02/2023
Actual
Sample size
Target
400
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 31933 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 307162 0
Commercial sector/Industry
Name [1] 307162 0
Baxter Healthcare Pty Ltd
Country [1] 307162 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Gold Coast University Hospital
1 Hospital Blvd,
Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 307754 0
None
Name [1] 307754 0
Address [1] 307754 0
Country [1] 307754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307277 0
Gold Coast Hospital and Health Service Ethics Committee
Ethics committee address [1] 307277 0
Gold Coast University Hospital
1 Hospital Blvd
Southport, QLD 4215
Ethics committee country [1] 307277 0
Australia
Date submitted for ethics approval [1] 307277 0
14/07/2020
Approval date [1] 307277 0
22/10/2020
Ethics approval number [1] 307277 0
HREC/2020/QGC/65969

Summary
Brief summary
A vaginal vault haematoma formation is a recognised complication of a hysterectomy and can be associated with post-operative infection, bleeding, pain, discharge, ileus, prolonged hospital stay or readmission, or even return to theatre. The aim of this randomised controlled trial is to evaluate the rate of sonographically proven vaginal vault haemotoma following a total laparoscopic hysterectomy with and without the use of TISSEEL. As secondary endpoints the rate of complications associated with a vaginal vault haemotoma post-TLH will be assessed including: re-admission, blood transfusion, vault infection requiring antibiotics, and return to theatre. Participants will include females aged 18 and over undergoing a total laparoscopic hysterectomy for benign pathology on theatre lists at the Gold Coast University Hospital under the supervision of the Gynaecology Director. After consenting, they will be randomly allocated with a 1:1 ratio. If the Director deems the use of TISSEEL is necessary due to the clinical situation then the participants will be excluded from the trial. Participants will be followed up with a phone call questionnaire regarding complications and undergo an ultrasound scan to evaluate for a vault haematoma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106654 0
Dr Sally Byford
Address 106654 0
Gold Coast University Hospital
1 Hospital Blvd,
Southport QLD 4215
Country 106654 0
Australia
Phone 106654 0
+61 7 5687 1125
Fax 106654 0
Email 106654 0
[email protected]
Contact person for public queries
Name 106655 0
Sally Byford
Address 106655 0
Gold Coast University Hospital
1 Hospital Blvd,
Southport QLD 4215
Country 106655 0
Australia
Phone 106655 0
+61 7 5687 1125
Fax 106655 0
Email 106655 0
[email protected]
Contact person for scientific queries
Name 106656 0
Sally Byford
Address 106656 0
Gold Coast University Hospital
1 Hospital Blvd,
Southport QLD 4215
Country 106656 0
Australia
Phone 106656 0
+61 7 5687 1125
Fax 106656 0
Email 106656 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
No IPD sharing has not been approved in this protocol by the Human Research Ethics Committee. While the protocol does provide provisions for the use of the data in future research, that research must be approved by a recognised ethics committee. Interested parties seeking access to the raw de-identified data may contact the principal investigator for further information.


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.