ERAS in Autologous Breast Reconstruction: A Pilot RCT

NCT04306003 | Completed

• 1 other identifier: ERAS-ABR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Over 26,000 Canadian women are diagnosed with breast cancer each year and 1 in 3 patients undergo mastectomy. With an upward of 40% of breast cancer patients seeking post-mastectomy breast reconstruction (PMBR), there is a significant opportunity to improve the quality of perioperative care for breast reconstruction patients. Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal, and evidence-based approach to perioperative care that safely reduces hospital length of stay and opioid use following colorectal surgery. ERAS recommendations have been proposed for women undergoing autologous PMBR who typically stay in hospital 4 to 5 days after surgery. However, the evidence to support ERAS in breast reconstruction is limited to observational studies compared to the numerous clinical trials in colorectal surgery. The goal of this study is to address this knowledge gap by evaluating the feasibility of conducting a RCT comparing ERAS to standard perioperative care.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast Reconstruction; Perioperative Care; Enhanced Recovery After Surgery; ERAS

Outcome Measures

Primary Outcomes (4)

• Feasibility (pertaining to patient eligibility)

  Proportion of screened patients who are eligible for the study

  8-months

• Feasibility (pertaining to patient recruitment)

  Proportion of eligible patients who are randomized

  8-months

• Feasibility (pertaining to adherence to follow-up assignment)

  Proportion of patients with missed assessments and incomplete data variables

  30 days post-surgery

• Feasibility (pertaining to adherence to ERAS protocol)

  Proportion of ERAS interventions followed and achieved

  Length of inpatient stay (3 to 7+ days)

Secondary Outcomes (6)

• Hospital Length of Stay

  1 week

• In-hospital opioid consumption

  1 week

• BREAST-Q

  Preop clinic appointment to 30-days post-surgery

• EQ-5D-5L

  Preop clinic appointment to 30-days post-surgery

• 30-days adverse event (composite outcome)

  30-days post-surgery

Study Arms (2)

Enhanced Recovery After Surgery (ERAS) pathway

EXPERIMENTAL

Preop 1. Diet: Solids until midnight before surgery with a carbohydrate rich drink before midnight and 3-hours prior to surgery. 2. Analgesia: Acetaminophen 975mg \& Celecoxib 400mg administered PO 1-hour before surgery. Intraop 1. Hypothermia prevention: Forced-air warming units and core temperature monitoring. 2. Fluid management: Euvolemic fluid management with balanced crystalloid solution. 3. Analgesia: 0.25% bupivacaine block of intercostal nerves and rectus sheath by the surgical team. Additional IV analgesia by anesthesiologist with the goal to minimize opioids. 4. PONV prophylaxis: Ondansetron 4-8mg IV during emergence. Postop 1. Diet: Clear fluids immediately post-op. Saline lock and advance to DAT on POD#1. 2. Analgesia: Routine administration of Acetaminophen 975mg PO q6h \& Celecoxib 200mg PO q12h. Opioids used as breakthrough analgesia only. No PCA. 3. Early mobilization: Mobilization within the first 24 hours after surgery with assistance.

Other: ERAS pathway

Standard Perioperative Care

ACTIVE COMPARATOR

Patients in the control arm received routine perioperative care as determined by respective surgeons participating in the study.

Other: Standard Perioperative Care

Interventions

ERAS pathway OTHER

See ERAS pathway arm description.

Enhanced Recovery After Surgery (ERAS) pathway

Standard Perioperative Care OTHER

See control arm description.

Standard Perioperative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of age 18 years or greater
• Able to understand and communicate in English
• Diagnosis of breast cancer or BRCA gene
• Undergoing (or previously had) unilateral or bilateral mastectomy
• Undergoing immediate or delayed DIEP breast reconstruction (unilateral or bilateral).
• Patients undergoing repeat breast reconstruction (secondary reconstruction) after a previously failed alloplastic or autologous reconstruction will be eligible to participate.
• Patients undergoing both DIEP and alloplastic reconstruction (e.g. DIEP reconstruction for one breast, alloplastic reconstruction for the other breast) will also be eligible to participate.

You may not qualify if:

• Non-ambulatory at baseline
• Pregnant
• Unable to provide informed consent or unable to complete quality of life questionnaires due to mental capacity, cognitive impairment, or language barrier.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyosuk Chin, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Marko Simunovic, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: ERAS is a complex intervention in which care providers cannot be blinded. Patients were provided a brief overview of ERAS without specific details of its interventions but were not informed of the group allocation. Patients were unaware of group allocation as they were unaware of the specific differences in the perioperative care between ERAS and standard care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: November 5, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

CA (2)