Breast CancerNCT06335550
Surgical and Patient Reported Outcomes in Robotic Mastectomy
A study testing Robotic mastectomy in people with Breast Cancer, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Robotic mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Nov 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 21-70, with invasive breast cancer, ductal carcinoma in situ (DCIS), Breast Cancer (BRCA) gene or other breast cancer genetic mutation carriers or high risk female patients who are otherwise candidates for conventional NSM/SSM will be eligible for the study. All suitable patients will be offered the option of R-NSM/ R-SSM.
- For patients with breast cancer (invasive or DCIS), selection criteria include but not limited to:
- Early breast cancer
- Tumor size less than 5 cm
- No evidence of lymph node metastases
- No evidence of skin or chest wall invasion.
Who cannot join
- Extensive axillary lymph node metastasis (Stage 3B or later)
- Heavy smokers (>20 cigarettes a day)
- High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction)
- Poor performance status or high risk for anaesthesia (ASA 3 and above)
- Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia
Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.
In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.
Read more
To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.
The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM.
- Conditions
- Breast Cancer
- Being tested
- Robotic mastectomy
- Keywords
- Breast cancer, Minimally invasive breast surgery, endoscopic breast surgery, robotic breast surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic mastectomyProcedure or surgery
Robotic mastectomy with or without reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Robotic mastectomy | Other | All consecutive cases of robotic mastectomy over the study duration Receives: Procedure: Robotic mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Outcomes - Operative parameters
- Operative parameters (in terms of docking time/console time and total operative time - defined as time taken from axilla staging procedure, robot docking time, console time, closure and time taken for reconstruction, if applicable
Measured: Postoperative Day 0-1
Surgical Outcomes - Length of stay (days)
- Length of stay (days)
Measured: Postoperative 30 days
Surgical Outcomes- 30-days morbidity/complications
- 30-days morbidity/complications
Measured: Postoperative 30 days
Secondary outcomes (2)
Oncologic outcomes
Short-term oncologic outcomes, such as positivity of margins
Measured: Postoperative 2 weeks until final histopathology results are available
Learning curve
Learning curve analysis using cumulative sum (CUSUM) method
Measured: Postoperative up to 2 years throughout study recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start24 Nov 2022
- Primary completion31 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mok Chi Wei, Changi General Hospital
- Investigators
- Chi Wei Mok, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335550
- Sponsor's protocol ID
- 2021/2680
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Robotic Mastectomy in Singapore (PRoMiSing I) Study: First Safety and Feasibility Prospective Cohort Study in South East Asia
- ClinicalTrials.gov ID
- NCT06335550
- Acronym / sponsor ID
- 2021/2680
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Minimally invasive breast surgery, endoscopic breast surgery, robotic breast surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.
In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.
To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.
The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic mastectomy | Other | Procedure: Robotic mastectomyAll consecutive cases of robotic mastectomy over the study duration |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 21-70, with invasive breast cancer, ductal carcinoma in situ (DCIS), Breast Cancer (BRCA) gene or other breast cancer genetic mutation carriers or high risk female patients who are otherwise candidates for conventional NSM/SSM will be eligible for the study. All suitable patients will be offered the option of R-NSM/ R-SSM.
- For patients with breast cancer (invasive or DCIS), selection criteria include but not limited to:
- Early breast cancer
- Tumor size less than 5 cm
- No evidence of lymph node metastases
Key exclusion criteria (5 listed)
- Extensive axillary lymph node metastasis (Stage 3B or later)
- Heavy smokers (>20 cigarettes a day)
- High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction)
- Poor performance status or high risk for anaesthesia (ASA 3 and above)
- Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic mastectomyRobotic mastectomy with or without reconstruction | Procedure or surgery | Robotic mastectomy |
Primary outcome
Surgical Outcomes - Operative parameters
Time frame: Postoperative Day 0-1
- Operative parameters (in terms of docking time/console time and total operative time - defined as time taken from axilla staging procedure, robot docking time, console time, closure and time taken for reconstruction, if applicable
Surgical Outcomes - Length of stay (days)
Time frame: Postoperative 30 days
- Length of stay (days)
Surgical Outcomes- 30-days morbidity/complications
Time frame: Postoperative 30 days
- 30-days morbidity/complications
2 secondary outcomes
Oncologic outcomes
Time frame: Postoperative 2 weeks until final histopathology results are available
Learning curve
Time frame: Postoperative up to 2 years throughout study recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Wei Mok principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic mastectomy in people with Breast Cancer, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Outcomes - Operative parameters (time frame: Postoperative Day 0-1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.