We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

RCT Implant Based Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558138
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : January 31, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Mastectomy Other: Discharge timing Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
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
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : January 5, 2025
Estimated Study Completion Date : January 5, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Rate of post-operative complications surgical site infection [ Time Frame: Up to 30 Days ]
    Assessed by patient report

  2. Number of Participants with Post-operative hematoma [ Time Frame: Up to 30 Days ]
    Assessed by patient report

  3. Number of Participants with Post-operative blood clots [ Time Frame: Up to 30 Days ]
    Assessed by patient report

  4. Number of Participants with Post-operative emergency department visits [ Time Frame: Up to 30 Days ]
    Assessed by patient report

  5. Number of Participants with Post-operative hospital readmissions [ Time Frame: Up to 30 Days ]
    Assessed by patient report

  6. Number of Participants with Post-operative re-operation [ Time Frame: Up to 30 Days ]
    Assessed by patient report


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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?


  6. 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")


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558138


Contacts
Layout table for location contacts
Contact: Christodoulos Kaoutzanis 720-516-9402 Christodoulos.Kaoutzanis@cuanschutz.edu

Locations
Layout table for location information
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Christodoulos Kaoutzanis       Christodoulos.Kaoutzanis@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Christodoulos Kaotzanis, MD University of Colorado, Denver
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04558138    
Other Study ID Numbers: 20-1055.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Reconstruction