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NCT04537312 Clinical Trial

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

Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial

Official title:
Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04537312
Other study ID # OSU-19199
Secondary ID NCI-2020-05349
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 17, 2020
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

  • 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
  • Breast Carcinoma In Situ
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Ductal, Breast
  • Carcinoma, Intraductal, Noninfiltrating
  • 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

Intervention

Procedure:
• Robot-assisted Nipple Sparing Mastectomy
Under RNSM
Other:
• Survey Administration
ancillary correlative
Device:
• RNSM
Robot-assisted Nipple Sparing Mastectomy

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
William Carson

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of removal of breast gland en bloc through RNSM Measure number of patients who had breast removed en bloc through RNSM incision. Up to 1 year
Primary Complication rate of patients with bleeding requiring re-operation Number of patients with bleeding requiring re-operation after RNSM. Up to 1 year
Primary Complication rate of patients with infection requiring antibiotics or re-operation Number of patients with infection after surgery requiring antibiotics or re-operation. Up to 1 year
Primary 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. Up to 1 year
Primary Perioperative Outcomes investigating the total duration of surgical time Investigate the total duration of the operation (surgical time data), Up to 1 year
Primary Perioperative Outcomes investigating length of surgery time Investigate the total duration of the operation (surgical time data) of each patient Up to 1 year
Primary Perioperative Outcomes investigating the length of hospitalization Investigate the length of hospitalization for each patient Up to 1 year
Secondary Surgeon musculoskeletal fatigue with RNSM using (SURG-TLX) survey Surgery Task Load Index (SURG-TLX) survey from each surgeon performing surgery. Up to 1 year
Secondary Surgeon musculoskeletal fatigue with RNSM using NMSQ questionnaire Musculo-Skeletal Questionnaire (NMSQ) from each surgeon performing surgery. Up to 1 year
Secondary 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. Up to 1 year
Secondary 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. Up to 1 year
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