RCT Implant Based Breast Reconstruction

• ClinicalTrials.gov Identifier: NCT04558138
• Recruitment Status: Recruiting
• First Posted: September 22, 2020
• Last Update Posted: January 31, 2023
• Sponsor: University of Colorado, Denver
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: August 17, 2020
• First Posted Date: September 22, 2020
• Last Update Posted Date: January 31, 2023
• Actual Study Start Date: August 20, 2020
• Estimated Primary Completion Date: January 5, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2020)

• Rate of post-operative complications surgical site infection [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Number of Participants with Post-operative hematoma [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Number of Participants with Post-operative blood clots [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Number of Participants with Post-operative emergency department visits [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Number of Participants with Post-operative hospital readmissions [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Number of Participants with Post-operative re-operation [ Time Frame: Up to 30 Days ]
  Assessed by patient report

Original Primary Outcome Measures (submitted: September 15, 2020)

• Rate of post-operative complications surgical site infection [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Post-operative hematoma [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Post-operative blood clots [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Post-operative emergency department visits [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Post-operative hospital readmissions [ Time Frame: Up to 30 Days ]
  Assessed by patient report
• Post-operative re-operation [ Time Frame: Up to 30 Days ]
  Assessed by patient report

Current Secondary Outcome Measures (submitted: September 15, 2020)

• Pain Score [ Time Frame: Up to 30 Days ]
  Pain control, as measured by a visual analog Numeric Pain Scale (NPS) number ranging from 0 (no pain at all) to 10 (worst pain ever) between the two groups.
• Opioid Consumption [ Time Frame: Post-Operative day 7 ]
  The following information will be collected from a combination of patient reported information and electronic medical review: amount of supplemental postoperative opioid analgesia (both intravenous and oral) used by the study participant from postoperative days 0 to 7.
• Opioid adverse effects [ Time Frame: Up to 30 Days ]
  The following effects/symptoms will be recorded as YES or NO if required admission to the hospital for management including use of IV medications: nausea, vomiting, constipation and urinary retention.
• Quality of life perceptions: QoR-15 [ Time Frame: Up to 30 Days ]
  QoR-15: This scale will be utilized to evaluate patient satisfaction. It captures patient reported postoperative assessment of various dimensions of health including patient support, comfort, emotions, physical independence, and pain. Patients rate each of the 15 statements from 1 (never) to 10 (always).
• Discharge perceptions [ Time Frame: Post-Operative day 7 ]
  Group A: Discharged the same day of surgery will be asked the following questions on postoperative 7: Did you feel that you were discharge home at the appropriate time? How uncomfortable were you the night of surgery, as measured by a visual analog NPS number ranging from 0 (not uncomfortable) to 10 (extremely uncomfortable)? What was the main benefit of going home right after surgery? What was your biggest complaint about being at home right after surgery? Group B: Patients admitted after surgery will be asked the following questions on postoperative 7: Did you feel that you were discharge home at the appropriate time? How uncomfortable were you the night of surgery, as measured by a visual analog NPS number ranging from 0 (not uncomfortable) to 10 (extremely uncomfortable)? What was the main benefit of being admitted to the hospital after surgery? What was your biggest complaint about being at the hospital after surgery?
• Quality of life perceptions: PROMIS-29 [ Time Frame: Up to 30 Days ]
  PROMIS-29: A generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity part of the PROMIS-29 (with 0 being "no pain" and 10 being "worst imaginable pain")

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RCT Implant Based Breast Reconstruction
• Official Title: A Randomized Controlled Trial in Patients Undergoing Immediate Implant-Based Breast Reconstruction Utilizing an Enhanced Recovery Pathway Comparing Outcomes and Patient Satisfaction Based on Time of Discharge
• Brief Summary: The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.
• Detailed Description: Traditionally patients undergoing mastectomy with immediate implant-based breast reconstruction were admitted to the hospital overnight. However, recent retrospective studies utilizing ERAS protocols have reported same day discharge as a possibility for this patient population. ERAS protocols for breast cancer surgery and reconstruction are becoming more popular. This along with the increasing utilization of prepectoral breast reconstruction that is associated with less postoperative pain and opioid use, are promising avenues to decrease the need for overnight hospital stay. If it can be shown that discharge on the same day of surgery does not pose any major risks compared to discharge on post-operative day one, there is the potential to decrease length of hospital stay, improve hospital capacity and dramatically decrease costs.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

After consent, patients will be randomized into one of two groups, either discharged day of surgery, or discharged day after surgery

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Mastectomy

Intervention

Other: Discharge timing

Patients will be discharged home on the day of surgery as opposed to POD #1

Study Arms

• Experimental: Discharge day of surgery
  Patient discharges day of surgery and given surveys to complete at home on post operative day (POD) #1 and #7.
  Intervention: Other: Discharge timing
• No Intervention: Discharge post operative day 1
  Patient Discharges POD #1 and completes survey prior to discharge. Patient given surveys to complete POD #7 at home.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 15, 2020): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 5, 2026
• Estimated Primary Completion Date: January 5, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Patients who will undergo immediate, (unilateral or bilateral)implant-based breast reconstruction following mastectomy for breast cancer or prophylaxis at the University of Colorado Anschutz Medical Campus and Highlands Ranch Campus.
2. Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
3. All adult (>18 years old), female patients who will undergo mastectomy for breast cancer or prophylaxis and immediate implant-based reconstruction who are able to complete surveys independently will be eligible for the study.
4. English and Spanish speaking
5. Patients will be included regardless of their current chemoradiation plan

Exclusion Criteria:

1. Age > 80 years
2. ASA 4
3. suboxone use
4. documented substance use disorder as defined by the DSM-5 (I.e. alcohol use disorder, opioid use disodrer, cocaine use disorder, etc). Marijuana use will not be considered a substance use disorder
5. OSA requiring CPAP
6. recent pneumonia (within 6 weeks)
7. BMI > 45 kg/m2 with any co-morbid condition that is not well controlled
8. poorly controlled diabetes (HgbA1c > 9)
9. Not English or Spanish speaking

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 19 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christodoulos Kaoutzanis; 720-516-9402; Christodoulos.Kaoutzanis@cuanschutz.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04558138
• Other Study ID Numbers: 20-1055.cc; P30CA046934 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Colorado, Denver
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Colorado, Denver
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Christodoulos Kaotzanis, MD; University of Colorado, Denver

• PRS Account: University of Colorado, Denver
• Verification Date: January 2023