MastectomyERAS_BreastNCT03181139
Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy
An observational study of Mastectomy and Breast Cancer Female, run by Monica Harbell.
Trial summary
Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Breast Cancer Female
- What is being tested?
- ERAS pathway for Total Mastectomy
- How many people
- 386 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 30 Apr 2016
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients at UCSF Mount Zion hospital who were scheduled for total mastectomy
Who may be able to join
- female patients at least 18 years old undergoing total skin sparing mastectomy at University of California San Francisco Mount Zion hospital
Who cannot join
- patients undergoing concurrent bilateral salpingo-oophorectomy, flap reconstruction
About this study
Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.
Read the detailed description
Retrospective analysis of pre- and post-Enhanced Recovery after surgery for total mastectomy pathway implementation in patients at Mount Zion Hospital. We examined perioperative opioid consumption, pain scores, post-operative nausea and vomiting, benzodiazepine use, length of stay for the time period before and after implementation of an Enhanced Recovery after Surgery pathway for Total mastectomy. Pathway features included preoperative acetaminophen and gabapentin, minimizing opioids, postoperative NSAIDs, Pecs blocks, and aggressive postoperative nausea and vomiting prophylaxis.
- Conditions
- Mastectomy, Breast Cancer Female
- Being tested
- ERAS pathway for Total Mastectomy
- Keywords
- Enhanced Recovery after Surgery (ERAS), Fast-track surgery, Pec Blocks, Mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS pathway for Total MastectomyOther
Enhanced Recovery after Surgery (ERAS) pathway for Total Mastectomy
| Study group | Role | What they receive |
|---|---|---|
| pre-ERAS | Patients cared for prior to the implementation of the Enhanced Recovery after surgery for total mastectomy pathway | |
| post-ERAS | patients cared for after the implementation of the Enhanced Recovery after surgery for total mastectomy pathway. Pathway included preoperative acetaminophen and gabapentin, Pec blocks, multimodal analgesia postoperatively and aggressive PONV treatment. Receives: Other: ERAS pathway for Total Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative opioid consumption
perioperative opioid consumption
Measured: through study completion (average of 1 year)
Secondary outcomes (5)
Post-operative nausea and vomiting (PONV)
incidence post-operative nausea and vomiting
Measured: through study completion (average of 1 year)
postoperative benzodiazepine use
amount of benzodiazepines used postoperatively for treatment of muscle spasm
Measured: through study completion (average of 1 year)
Length of stay (LOS)
Length of stay
Measured: through study completion (average of 1 year)
Pain score
highest pain score perioperatively
Measured: through study completion (average of 1 year)
Surgery duration
length of surgery (min)
Measured: through study completion (average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Jul 2013
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monica Harbell
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Zion Health Fund
- Responsible party
- Sponsor-investigator, Monica Harbell, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181139
- Sponsor's protocol ID
- ERASBreast
- Acronym
- ERAS_Breast
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy
- ClinicalTrials.gov ID
- NCT03181139
- Acronym / sponsor ID
- ERAS_Breast / ERASBreast
- Conditions
- Mastectomy, Breast Cancer Female
- Keywords
- Enhanced Recovery after Surgery (ERAS), Fast-track surgery, Pec Blocks, Mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Monica HarbellUniversity, hospital or other
- Collaborators
- Mount Zion Health Fund
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 8 Jun 2017 (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.
Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.
Detailed description
Retrospective analysis of pre- and post-Enhanced Recovery after surgery for total mastectomy pathway implementation in patients at Mount Zion Hospital. We examined perioperative opioid consumption, pain scores, post-operative nausea and vomiting, benzodiazepine use, length of stay for the time period before and after implementation of an Enhanced Recovery after Surgery pathway for Total mastectomy. Pathway features included preoperative acetaminophen and gabapentin, minimizing opioids, postoperative NSAIDs, Pecs blocks, and aggressive postoperative nausea and vomiting prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-ERAS | – | –Patients cared for prior to the implementation of the Enhanced Recovery after surgery for total mastectomy pathway |
| post-ERAS | – | Other: ERAS pathway for Total Mastectomypatients cared for after the implementation of the Enhanced Recovery after surgery for total mastectomy pathway. Pathway included preoperative acetaminophen and gabapentin, Pec blocks, multimodal analgesia postoperatively and aggressive PONV treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients at UCSF Mount Zion hospital who were scheduled for total mastectomy
Key inclusion criteria (1 listed)
- female patients at least 18 years old undergoing total skin sparing mastectomy at University of California San Francisco Mount Zion hospital
Key exclusion criteria (1 listed)
- patients undergoing concurrent bilateral salpingo-oophorectomy, flap reconstruction
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 |
|---|---|---|
| ERAS pathway for Total MastectomyEnhanced Recovery after Surgery (ERAS) pathway for Total Mastectomy | Other | post-ERAS |
Primary outcome
perioperative opioid consumption
Time frame: through study completion (average of 1 year)
perioperative opioid consumption
5 secondary outcomes
Post-operative nausea and vomiting (PONV)
Time frame: through study completion (average of 1 year)
postoperative benzodiazepine use
Time frame: through study completion (average of 1 year)
Length of stay (LOS)
Time frame: through study completion (average of 1 year)
Pain score
Time frame: through study completion (average of 1 year)
Surgery duration
Time frame: through study completion (average of 1 year)
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 8 Jun 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy and Breast Cancer Female, run by Monica Harbell.
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 1 inclusion and 1 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
perioperative opioid consumption (time frame: through study completion (average of 1 year)). 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 8 Jun 2017.