MastectomyNCT04558138
RCT Implant Based Breast Reconstruction
A study testing Discharge timing in people with Mastectomy, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Mastectomy
- What is being tested?
- Discharge timing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 13 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
- 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.
- English and Spanish speaking
- Patients will be included regardless of their current chemoradiation plan
Who cannot join
- Age > 80 years
- ASA 4
- suboxone use
- 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
- OSA requiring CPAP
- recent pneumonia (within 6 weeks)
Show all 9Show fewer
- BMI > 45 kg/m2 with any co-morbid condition that is not well controlled
- poorly controlled diabetes (HgbA1c > 9)
- Not English or Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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
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.
Read the 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.
- Conditions
- Mastectomy
- Being tested
- Discharge timing
- Keywords
- Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge timingOther
Patients will be discharged home on the day of surgery as opposed to POD #1
| Study group | Role | What they receive |
|---|---|---|
| Discharge day of surgery | Experimental | Patient discharges day of surgery and given surveys to complete at home on post operative day (POD) #1 and #7. Receives: Other: Discharge timing |
| Discharge post operative day 1 | No intervention | Patient Discharges POD #1 and completes survey prior to discharge. Patient given surveys to complete POD #7 at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative complications surgical site infection
Assessed by patient report
Measured: Up to 30 Days
Number of Participants with Post-operative hematoma
Assessed by patient report
Measured: Up to 30 Days
Number of Participants with Post-operative blood clots
Assessed by patient report
Measured: Up to 30 Days
Number of Participants with Post-operative emergency department visits
Assessed by patient report
Measured: Up to 30 Days
Number of Participants with Post-operative hospital readmissions
Assessed by patient report
Measured: Up to 30 Days
Number of Participants with Post-operative re-operation
Assessed by patient report
Measured: Up to 30 Days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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?
Measured: 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")
Measured: Up to 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start20 Aug 2020
- Primary completion16 Jan 2024
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christodoulos Kaotzanis, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558138
- Sponsor's protocol ID
- 20-1055.cc
- Other IDs
- P30CA046934
- Status last verified
- Nov 2025
- First submitted
- 17 Aug 2020
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04558138
- Acronym / sponsor ID
- 20-1055.cc
- Conditions
- Mastectomy
- Keywords
- Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After consent, patients will be randomized into one of two groups, either discharged day of surgery, or discharged day after surgery
| Arm | Type | Receives |
|---|---|---|
| Discharge day of surgery | Experimental | Other: Discharge timingPatient discharges day of surgery and given surveys to complete at home on post operative day (POD) #1 and #7. |
| Discharge post operative day 1 | No intervention | –Patient Discharges POD #1 and completes survey prior to discharge. Patient given surveys to complete POD #7 at home. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
- 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.
- English and Spanish speaking
- Patients will be included regardless of their current chemoradiation plan
Key exclusion criteria (9 listed)
- Age > 80 years
- ASA 4
- suboxone use
- 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
- OSA requiring CPAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discharge timingPatients will be discharged home on the day of surgery as opposed to POD #1 | Other | Discharge day of surgery |
Primary outcome
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
6 secondary outcomes
Pain Score
Time frame: Up to 30 Days
Opioid Consumption
Time frame: Post-Operative day 7
Opioid adverse effects
Time frame: Up to 30 Days
Quality of life perceptions: QoR-15
Time frame: Up to 30 Days
Discharge perceptions
Time frame: Post-Operative day 7
Quality of life perceptions: PROMIS-29
Time frame: Up to 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christodoulos Kaotzanis, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge timing in people with Mastectomy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative complications surgical site infection (time frame: Up to 30 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.