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

Not Applicable

Active, not recruiting

• Conditions: Anatomic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prophylactic Mastectomy; Ductal Breast Carcinoma In Situ; Prognostic Stage IB Breast Cancer AJCC v8
• Interventions: Procedure: Robot-assisted Nipple Sparing Mastectomy; Other: Survey Administration; Device: RNSM

• Registration Number: NCT04537312
• Lead Sponsor: William Carson

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.

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-03
• Study Start: 2020-11-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (RNSM, surveys)	RNSM	RNMS Surveys
Supportive care (RNSM, surveys)	Survey Administration	RNMS Surveys
Supportive care (RNSM, surveys)	Robot-assisted Nipple Sparing Mastectomy	RNMS Surveys

Primary Outcome Measures

Name	Time	Method
Complication rate of patients with bleeding requiring re-operation	Up to 1 year	Number of patients with bleeding requiring re-operation after RNSM.
Perioperative Outcomes investigating the length of hospitalization	Up to 1 year	Investigate the length of hospitalization for each patient
Perioperative Outcomes investigating length of surgery time	Up to 1 year	Investigate the total duration of the operation (surgical time data) of each patient
Feasibility of removal of breast gland en bloc through RNSM	Up to 1 year	Measure number of patients who had breast removed en bloc through RNSM incision.
Complication rate of patients with Mastectomy flap (SKIN flap score)	Up to 1 year	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.
Complication rate of patients with infection requiring antibiotics or re-operation	Up to 1 year	Number of patients with infection after surgery requiring antibiotics or re-operation.
Perioperative Outcomes investigating the total duration of surgical time	Up to 1 year	Investigate the total duration of the operation (surgical time data),

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes	Up to 1 year	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.
Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey	Up to 1 year	Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery.
Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire	Up to 1 year	Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States