Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000551897
Ethics application status
Approved
Date submitted
4/03/2021
Date registered
11/05/2021
Date last updated
11/05/2021
Date data sharing statement initially provided
11/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing clinical and and quality-of-life outcomes for breast cancer patients undergoing sub-pectoral vs. pre-pectoral implant-based breast reconstruction post mastectomy.
Scientific title
Clinical and and quality-of-life outcomes of pre-pectoral and sub-pectoral breast reconstruction in breast cancer patients: a prospective multi-centre cohort study from Sydney, Australia
Secondary ID [1] 303610 0
Nil known
Universal Trial Number (UTN)
U1111-1265-7534
Trial acronym
PRASE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 320982 0
breast reconstruction 320983 0
Condition category
Condition code
Surgery 318790 318790 0 0
Surgical techniques
Cancer 319267 319267 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure consists of the patient undergoing the newer method of implant-based breast reconstruction, in which the implant is placed superficial to the pectoralis major muscle. The surgeon and patient will make a joint decision about which type of reconstruction the patient would like to proceed with (the alternative being sub-pectoral reconstruction, the control arm). Participating in the study will not affect this decision, since the study is strictly observational in nature.

If patients choose to participate, they will allow researchers to audit their medical records (only those records that relate to baseline demographic data or surgical outcomes/complications). They will also be asked to fill out a number of questionnaires during their scheduled post-operative visits. Participating patients will not be required to attend any follow-up appointments beyond those that would be scheduled if they had chosen not to participate in the study. Filling out these questionnaires will take no more than an extra 30 minutes for each visit.

Participants will be followed-up for 2 years post-operatively. Researchers will audit their medical records to assess any complications related to the initial surgery, as well as any signs of cancer recurrence.
Intervention code [1] 319894 0
Not applicable
Comparator / control treatment
The control treatment consists of the patient undergoing the traditional method of implant-based breast reconstruction, in which the implant is placed deep to the pectoralis major muscle. The surgeon and patient will make a joint decision about which type of reconstruction the patient would like to proceed with (the alternative being pre-pectoral reconstruction, the treatment arm). Participating in the study will not affect this decision, since the study is strictly observational in nature.

If patients choose to participate, they will allow researchers to audit their medical records (only those records that relate to baseline demographic data or surgical outcomes/complications). They will also be asked to fill out a number of questionnaires during their scheduled post-operative visits. Participating patients will not be required to attend any follow-up appointments beyond those that would be scheduled if they had chosen not to participate in the study. Filling out these questionnaires will take no more than an extra 30 minutes for each visit.

Participants will be followed-up for 2 years post-operatively. Researchers will audit their medical records to assess any complications related to the initial surgery, as well as any signs of cancer recurrence.
Control group
Active

Outcomes
Primary outcome [1] 326732 0
Implant loss is defined as any unplanned and unexpected expatriation or loss of the implant including removal as a result of infection. This outcome will be gleaned from patient medical records.

Timepoint [1] 326732 0
three months, one year and two years post-operatively
Primary outcome [2] 326733 0
Re-admission for surgical complication. Complications include infection (minor requiring a script for oral antibiotics or major requiring intravenous antibiotics and/or hospital admission and/or surgery for debridement), seroma (minor requiring monitoring and/or outpatient aspiration or major requiring surgery), haematoma, necrosis (flap or nipple), dehiscence or red breast syndrome.

This outcome will also be gleaned from patient medical records.
Timepoint [2] 326733 0
three months, one year and two years post-operatively
Primary outcome [3] 326734 0
Re-operation for surgical complication. Complications include infection (minor requiring a script for oral antibiotics or major requiring intravenous antibiotics and/or hospital admission and/or surgery for debridement), seroma (minor requiring monitoring and/or outpatient aspiration or major requiring surgery), haematoma, necrosis (flap or nipple), dehiscence or red breast syndrome.

This outcome will also be gleaned from patient medical records. We assume that patients who under go repeat operations for complications will do so at the same hospital that they had their initial surgery. However, where this is not the case, the treating surgeon would record the data in the medical records from clinic or rooms.
Timepoint [3] 326734 0
three months, one year and two years post-operatively
Secondary outcome [1] 392514 0
Quality of life as measured by BREAST-Q questionnaire (reconstruction module)
Timepoint [1] 392514 0
pre-operatively, at 1 year post-operatively and at 2 years post-operatively
Secondary outcome [2] 393955 0
Aesthetic outcome as measured by Kroll Score, which will be completed by both patient and surgeon.
Timepoint [2] 393955 0
1 year post operatively
Secondary outcome [3] 393956 0
Capsular contracture, as measured by the Baker Score completed by the treating surgeon
Timepoint [3] 393956 0
1 year post-operatively
Secondary outcome [4] 393957 0
Animation deformity, as measured by the Becker Score, which will be completed by the treating surgeon
Timepoint [4] 393957 0
1 year post-operatively

Eligibility
Key inclusion criteria
- 18 years old or older
- Stage 0 - III breast cancer
- Not pregnant
- Able to understand the consent process
- Nipple or skin sparing mastectomy with immediate reconstruction (expander or implant based)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Stage IV breast cancer
- Immediate autologous reconstruction (with or without implants)
- Delayed reconstruction (not including revision of expanders)
- Revision surgery (not including revision of expanders)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be undertaken using SPSS. The analysis will consist of a comparison of baseline characteristics of the sub-pectoral vs. pre-pectoral reconstruction groups. We will then analyse the rates of complications using a one-sided t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2021
Actual
Date of last participant enrolment
Anticipated
15/05/2023
Actual
Date of last data collection
Anticipated
15/05/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18858 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 18859 0
North Shore Private Hospital - St Leonards
Recruitment hospital [3] 18860 0
Mater Sydney - North Sydney
Recruitment hospital [4] 18861 0
Westmead Hospital - Westmead
Recruitment hospital [5] 18862 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 33359 0
2065 - St Leonards
Recruitment postcode(s) [2] 33360 0
2060 - North Sydney
Recruitment postcode(s) [3] 33361 0
2145 - Westmead
Recruitment postcode(s) [4] 33362 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308031 0
Self funded/Unfunded
Name [1] 308031 0
Country [1] 308031 0
Primary sponsor type
Individual
Name
Isobel Yeap
Address
The Poche Centre, 40 Rocklands Rd, Wollstonecraft, New South Wales, 2065
Country
Australia
Secondary sponsor category [1] 308754 0
University
Name [1] 308754 0
The University of Sydney
Address [1] 308754 0
The University of Sydney, Camperdown NSW 2006
Country [1] 308754 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308024 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 308024 0
Ethics committee country [1] 308024 0
Australia
Date submitted for ethics approval [1] 308024 0
Approval date [1] 308024 0
20/08/2020
Ethics approval number [1] 308024 0
Ethics committee name [2] 308026 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 308026 0
Ethics committee country [2] 308026 0
Australia
Date submitted for ethics approval [2] 308026 0
Approval date [2] 308026 0
17/02/2021
Ethics approval number [2] 308026 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109258 0
Dr Isobel Yeap
Address 109258 0
The Poche Centre, 40 Rocklands Rd, Wollstonecraft, New South Wales, 2065
Country 109258 0
Australia
Phone 109258 0
+61 0406549239
Fax 109258 0
Email 109258 0
[email protected]
Contact person for public queries
Name 109259 0
Isobel Yeap
Address 109259 0
The Poche Centre, 40 Rocklands Rd, Wollstonecraft, New South Wales, 2065
Country 109259 0
Australia
Phone 109259 0
+61 406549239
Fax 109259 0
Email 109259 0
[email protected]
Contact person for scientific queries
Name 109260 0
Isobel Yeap
Address 109260 0
The Poche Centre, 40 Rocklands Rd, Wollstonecraft, New South Wales, 2065
Country 109260 0
Australia
Phone 109260 0
+61 406549239
Fax 109260 0
Email 109260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified raw data that is the basis of public results will be shared if requested
When will data be available (start and end dates)?
The data will be available from the end of the trial (once all data has been collected) and will be available for 5 years, since this is the duration of time the data will be stored.
Available to whom?
It can be made available to scientific establishments, scientific journals or other researchers who would like to better understand or interrogate our results. It will not be publicly available but can be requested.
Available for what types of analyses?
Data will be made available if other scientific persons or institutions want to better understand our results. Data will also be made available to scientific persons who may be seeking to conduct a systematic review or meta-analysis.
How or where can data be obtained?
The data can be obtained by making a request to the primary investigator via email ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10897Informed consent form    PICF attached 381550-(Uploaded-04-03-2021-20-58-24)-Study-related document.pdf



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.