Surgical and Patient Reported Outcomes in Robotic Mastectomy | NCT06335550

Studies
Surgical and Patient Reported Outcomes in Robotic Mastectomy

NCT06335550

Sponsor

Changi General Hospital

Status

Completed

Last Update Posted

Mar 28, 2024Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Robotic mastectomy

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Mar 1, 2024Actual

First Submitted Date

Mar 4, 2024

First Submission Date that Met QC Criteria

Mar 21, 2024

First Posted Date

Mar 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2024

Last Update Posted Date

Mar 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic mastectomy	Other	All consecutive cases of robotic mastectomy over the study duration	Procedure: Robotic mastectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic mastectomy	Procedure	Robotic mastectomy with or without reconstruction	Robotic mastectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Postoperative Day 0-1
Surgical Outcomes - Length of stay (days)	- Length of stay (days)	Postoperative 30 days
Surgical Outcomes- 30-days morbidity/complications	- 30-days morbidity/complications	Postoperative 30 days

Secondary Outcomes

Measure	Description	Time Frame
Oncologic outcomes	Short-term oncologic outcomes, such as positivity of margins	Postoperative 2 weeks until final histopathology results are available
Learning curve	Learning curve analysis using cumulative sum (CUSUM) method

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Chi Wei Mok	Changi General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Changi General Hospital		Singapore		529889	Singapore

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 5, 2023	Mar 8, 2024	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	May 3, 2023	Mar 8, 2024	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

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Browse Branches

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