Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy (ERAS_Breast)

June 6, 2017 updated by: Monica Harbell
Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients at UCSF Mount Zion hospital who were scheduled for total mastectomy

Description

Inclusion Criteria:

  • female patients at least 18 years old undergoing total skin sparing mastectomy at University of California San Francisco Mount Zion hospital

Exclusion Criteria:

  • patients undergoing concurrent bilateral salpingo-oophorectomy, flap reconstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: ERAS pathway for Total Mastectomy
Enhanced Recovery after Surgery (ERAS) pathway for Total Mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative opioid consumption
Time Frame: through study completion (average of 1 year)
perioperative opioid consumption
through study completion (average of 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative nausea and vomiting (PONV)
Time Frame: through study completion (average of 1 year)
incidence post-operative nausea and vomiting
through study completion (average of 1 year)
postoperative benzodiazepine use
Time Frame: through study completion (average of 1 year)
amount of benzodiazepines used postoperatively for treatment of muscle spasm
through study completion (average of 1 year)
Length of stay (LOS)
Time Frame: through study completion (average of 1 year)
Length of stay
through study completion (average of 1 year)
Pain score
Time Frame: through study completion (average of 1 year)
highest pain score perioperatively
through study completion (average of 1 year)
Surgery duration
Time Frame: through study completion (average of 1 year)
length of surgery (min)
through study completion (average of 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monica Harbell

Collaborators

Mount Zion Health Fund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

April 30, 2016

Study Completion (Actual)

April 30, 2016

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERASBreast

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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