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Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robot-assisted Nipple Sparing Mastectomy
Survey Administration
RNSM
Sponsored by
William Carson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Surgical candidates, per standard of care for:

    • Nipple sparing resection and reconstruction OR
    • Prophylactic mastectomy for risk reduction mastectomy OR
    • Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
  • Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Pregnant or nursing women

  • Patients with:

    • Inflammatory breast cancer
    • Skin involvement with tumor
    • Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor
    • Grade 3 ptosis of nipple
  • Smokers with heavy current use of nicotine (defined as > 20 cigarettes/day)
  • Patients that are high risk for anesthesia, as documented in medical record
  • Patients that do not have the ability to give informed consent
  • Prisoner status at surgical clinic visit
  • Bra cup size greater than C cup
  • Previous thoracic radiation history (for any reason)

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (RNSM, surveys)

Arm Description

RNMS Surveys

Outcomes

Primary Outcome Measures

Feasibility of removal of breast gland en bloc through RNSM
Measure number of patients who had breast removed en bloc through RNSM incision.
Complication rate of patients with bleeding requiring re-operation
Number of patients with bleeding requiring re-operation after RNSM.
Complication rate of patients with infection requiring antibiotics or re-operation
Number of patients with infection after surgery requiring antibiotics or re-operation.
Complication rate of patients with Mastectomy flap (SKIN flap score)
Number of patients with mastectomy flap or nipple-areolar complex necrosis as measured using the SKIN flap score after surgery. Score of A1 indicates normal skin, D4 indicates total full thickness necrosis.
Perioperative Outcomes investigating the total duration of surgical time
Investigate the total duration of the operation (surgical time data),
Perioperative Outcomes investigating length of surgery time
Investigate the total duration of the operation (surgical time data) of each patient
Perioperative Outcomes investigating the length of hospitalization
Investigate the length of hospitalization for each patient

Secondary Outcome Measures

Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey
Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery.
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire
Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery.
Patient Reported Outcomes
Monofilament testing to test for sensation recovery after surgery from each participant. Semmes Weinstein monofilament exam; sensation to series of monofilament with different thickness, compare sensation to preoperative exam.
Patient Reported Outcomes
Patient satisfaction with the breast after surgery measured by BREAST-Q survey. Lowest score = 0, highest = 100 with higher scores indicating better outcomes / quality of life.

Full Information

First Posted
August 18, 2020
Last Updated
October 1, 2023
Sponsor
William Carson
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1. Study Identification

Unique Protocol Identification Number
NCT04537312
Brief Title
Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
Official Title
Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Carson

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.
Detailed Description
With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel. This is a single-arm pilot study for feasibility and safety of RNSM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Ductal Breast Carcinoma In Situ, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prophylactic Mastectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (RNSM, surveys)
Arm Type
Experimental
Arm Description
RNMS Surveys
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted Nipple Sparing Mastectomy
Intervention Description
Under RNSM
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
ancillary correlative
Intervention Type
Device
Intervention Name(s)
RNSM
Intervention Description
Robot-assisted Nipple Sparing Mastectomy
Primary Outcome Measure Information:
Title
Feasibility of removal of breast gland en bloc through RNSM
Description
Measure number of patients who had breast removed en bloc through RNSM incision.
Time Frame
Up to 1 year
Title
Complication rate of patients with bleeding requiring re-operation
Description
Number of patients with bleeding requiring re-operation after RNSM.
Time Frame
Up to 1 year
Title
Complication rate of patients with infection requiring antibiotics or re-operation
Description
Number of patients with infection after surgery requiring antibiotics or re-operation.
Time Frame
Up to 1 year
Title
Complication rate of patients with Mastectomy flap (SKIN flap score)
Description
Number of patients with mastectomy flap or nipple-areolar complex necrosis as measured using the SKIN flap score after surgery. Score of A1 indicates normal skin, D4 indicates total full thickness necrosis.
Time Frame
Up to 1 year
Title
Perioperative Outcomes investigating the total duration of surgical time
Description
Investigate the total duration of the operation (surgical time data),
Time Frame
Up to 1 year
Title
Perioperative Outcomes investigating length of surgery time
Description
Investigate the total duration of the operation (surgical time data) of each patient
Time Frame
Up to 1 year
Title
Perioperative Outcomes investigating the length of hospitalization
Description
Investigate the length of hospitalization for each patient
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey
Description
Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery.
Time Frame
Up to 1 year
Title
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire
Description
Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery.
Time Frame
Up to 1 year
Title
Patient Reported Outcomes
Description
Monofilament testing to test for sensation recovery after surgery from each participant. Semmes Weinstein monofilament exam; sensation to series of monofilament with different thickness, compare sensation to preoperative exam.
Time Frame
Up to 1 year
Title
Patient Reported Outcomes
Description
Patient satisfaction with the breast after surgery measured by BREAST-Q survey. Lowest score = 0, highest = 100 with higher scores indicating better outcomes / quality of life.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Surgical candidates, per standard of care for: Nipple sparing resection and reconstruction OR Prophylactic mastectomy for risk reduction mastectomy OR Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Pregnant or nursing women Patients with: Inflammatory breast cancer Skin involvement with tumor Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor Grade 3 ptosis of nipple Smokers with heavy current use of nicotine (defined as > 20 cigarettes/day) Patients that are high risk for anesthesia, as documented in medical record Patients that do not have the ability to give informed consent Prisoner status at surgical clinic visit Bra cup size greater than C cup Previous thoracic radiation history (for any reason)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Carson, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34782341
Citation
Park KU, Lee S, Sarna A, Chetta M, Schulz S, Agnese D, Grignol V, Carson W, Skoracki RJ. Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). BMJ Open. 2021 Nov 15;11(11):e050173. doi: 10.1136/bmjopen-2021-050173.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

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Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)

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