RCT Implant Based Breast Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mastectomy
• Intervention / Treatment: Other: Discharge timing

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
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christodoulos Kaoutzanis; Phone Number: 720-516-9402; Email: Christodoulos.Kaoutzanis@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Christodoulos Kaoutzanis; Email: Christodoulos.Kaoutzanis@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Discharge timing; Patients will be discharged home on the day of surgery as opposed to POD #1
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	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.	Up to 30 Days
Opioid Consumption	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.	Post-Operative day 7
Opioid adverse effects	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.	Up to 30 Days
Quality of life perceptions: QoR-15	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).	Up to 30 Days
Discharge perceptions	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?	Post-Operative day 7
Quality of life perceptions: PROMIS-29	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")	Up to 30 Days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christodoulos Kaotzanis, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Estimated): January 5, 2025
• Study Completion (Estimated): January 5, 2026

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Reconstruction
• Other Study ID Numbers: 20-1055.cc; P30CA046934 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No