NCT03181139

Brief Summary

Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

June 2, 2017

Last Update Submit

June 6, 2017

Conditions

MastectomyBreast Cancer Female

Keywords

Enhanced Recovery after Surgery (ERAS)Fast-track surgeryPec BlocksMastectomy

Outcome Measures

Primary Outcomes (1)

  • perioperative opioid consumption

    perioperative opioid consumption

    through study completion (average of 1 year)

Secondary Outcomes (5)

  • Post-operative nausea and vomiting (PONV)

    through study completion (average of 1 year)

  • postoperative benzodiazepine use

    through study completion (average of 1 year)

  • Length of stay (LOS)

    through study completion (average of 1 year)

  • Pain score

    through study completion (average of 1 year)

  • Surgery duration

    through study completion (average of 1 year)

Study Arms (2)

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

Interventions

ERAS pathway for Total MastectomyOTHER

Enhanced Recovery after Surgery (ERAS) pathway for Total Mastectomy

post-ERAS

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients undergoing concurrent bilateral salpingo-oophorectomy, flap reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mastectomy, Simple

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 8, 2017

Study Start

July 1, 2013

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share