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ERAS in Autologous Breast Reconstruction: A Pilot RCT (ERAS-ABR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04306003
Recruitment Status : Completed
First Posted : March 12, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Brian Hyosuk Chin, Hamilton Health Sciences Corporation

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: ERAS pathway Other: Standard Perioperative Care Not Applicable

Detailed Description:

1.1 Primary research question To determine the feasibility of a randomized controlled trial comparing an Enhanced Recovery After Surgery (ERAS) protocol to conventional perioperative care for adult women with breast cancer undergoing post-mastectomy autologous breast reconstruction.

1.2 Background and rationale Over 26,000 Canadian women are diagnosed with breast cancer every year. While the 5-year survival of breast cancer has improved to 87% in Canada, 1 in 3 breast cancer patients that receive mastectomy experience a negative impact in quality of life. Breast reconstruction can improve the physical, psychosocial and sexual well-being of patients after mastectomy. With an upward of 40% of breast cancer patients who undergo post-mastectomy breast reconstruction, there is a significant opportunity to improve the quality of surgical care for breast reconstruction patients.

Breast reconstruction can be classified into alloplastic (implant-based) and autologous (tissue-based) reconstruction. While alloplastic reconstruction is the most common form of breast reconstruction in North America, autologous reconstruction using the patient's own tissue confers superior long-term satisfaction and quality of life. The gold standard of autologous reconstruction is the deep inferior epigastric perforator (DIEP) flap which uses the patients' abdominal tissue to reconstruct the breast using microvascular techniques, while preserving the abdominal musculature. The DIEP reconstruction is surgically more complex than the alloplastic approach, involving surgery at the breasts, abdominal donor site, and reattachment of the abdominal tissue to blood vessels in the chest using microsurgery. Consequently, patients undergoing DIEP reconstruction have an increased length of hospital stay and increased use of opioid analgesics. According to the Canadian Institute for Health Information, the average hospital cost for a patient undergoing breast reconstruction is $3,715 per day. Reducing postsurgical opioid use and containing healthcare costs is important to the Canadian public and resource-constrained healthcare system.

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 some surgical procedures.16-18 ERAS is the standard of care in colorectal surgery and its advantages are supported by a meta-analysis of 16 randomized controlled trials (RCT). Although ERAS guidelines have been developed for other surgical procedures, the evidence supporting the efficacy of ERAS for non-colorectal surgery is limited. An ERAS guideline for perioperative care of alloplastic and autologous breast reconstruction patients has been established. Main recommendations include minimizing preoperative fasting, postoperative nausea and vomiting prophylaxis, multimodal opioid-sparing analgesia, early feeding and early mobilization. Despite this, the evidence that these recommendations improve care in breast reconstruction is limited. A recent meta-analysis of ERAS in breast reconstruction found that ERAS reduces hospital length of stay by a mean 1.58 days and opioid consumption by 248mg of oral morphine equivalent without an increase in complications. However and to emphasize, none of these studies were RCTs and thus all were subject to the numerous biases associated with observational studies. Currently there is no level-1 evidence to support ERAS in autologous breast reconstruction despite the previously mentioned consensus guideline. A properly designed and executed RCT of ERAS in breast reconstruction would contribute evidence on ERAS in the perioperative care of breast reconstruction patients.

1.3 Objective of the study To conduct a pilot RCT comparing ERAS to conventional perioperative care for patients undergoing autologous DIEP breast reconstruction. As a pilot trial, the primary objective of the study is to assess feasibility outcomes: 1) patient eligibility, 2) recruitment, 3) retention and 4) adherence to the ERAS protocol. The design and conduct of the proposed pilot study will mirror the methodology of the definitive trial including randomization, interventions, and clinical outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Surgery in Autologous Breast Reconstruction: A Pilot Randomized Controlled Trial
Actual Study Start Date : November 5, 2019
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enhanced Recovery After Surgery (ERAS) pathway

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
See ERAS pathway arm description.

Active Comparator: Standard Perioperative Care
Patients in the control arm received routine perioperative care as determined by respective surgeons participating in the study.
Other: Standard Perioperative Care
See control arm description.




Primary Outcome Measures :
  1. Feasibility (pertaining to patient eligibility) [ Time Frame: 8-months ]
    Proportion of screened patients who are eligible for the study

  2. Feasibility (pertaining to patient recruitment) [ Time Frame: 8-months ]
    Proportion of eligible patients who are randomized

  3. Feasibility (pertaining to adherence to follow-up assignment) [ Time Frame: 30 days post-surgery ]
    Proportion of patients with missed assessments and incomplete data variables

  4. Feasibility (pertaining to adherence to ERAS protocol) [ Time Frame: Length of inpatient stay (3 to 7+ days) ]
    Proportion of ERAS interventions followed and achieved


Secondary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: 1 week ]
    Cumulative length of hospital stay post-breast reconstruction.

  2. In-hospital opioid consumption [ Time Frame: 1 week ]
    Cumulative total opioids used during inpatient stay from PACU to discharge converted as oral morphine equivalent. Opioids given during intraoperative phase will not be considered.

  3. BREAST-Q [ Time Frame: Preop clinic appointment to 30-days post-surgery ]
    Reconstruction module of BREAST-Q (patient-reported outcome) obtained at baseline during preoperative clinic visit and 30-days post-surgery.

  4. EQ-5D-5L [ Time Frame: Preop clinic appointment to 30-days post-surgery ]
    General health-related quality of life measure (patient-reported outcome) obtained at baseline during preoperative clinic visit and 30-days post-surgery.

  5. 30-days adverse event (composite outcome) [ Time Frame: 30-days post-surgery ]

    Proportion of patients experiencing the following event(s):

    1. Flaps requiring operative salvage or debridement
    2. Hematoma requiring operative drainage/evacuation
    3. Surgical site infection requiring hospital admission and IV antibiotic treatment
    4. DVT
    5. Pulmonary Emboli
    6. Cardiovascular event (myocardial injury, stroke, new atrial fibrillation, congestive heart failure)

  6. 30-days additional resource utilization (composite outcome) [ Time Frame: 30-days post-surgery ]

    Proportion of patients requiring:

    1. Visit to ER or Urgent Care
    2. Hospital readmission
    3. Additional surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women of age 18 years or greater
  2. Able to understand and communicate in English
  3. Diagnosis of breast cancer or BRCA gene
  4. Undergoing (or previously had) unilateral or bilateral mastectomy
  5. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306003


Locations
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Canada, Ontario
Juravinski Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Hyosuk Chin, MD McMaster University
Principal Investigator: Marko Simunovic, MD Hamilton Health Sciences Corporation
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Responsible Party: Brian Hyosuk Chin, Principal Investigator, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT04306003    
Other Study ID Numbers: ERAS-ABR
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Hyosuk Chin, Hamilton Health Sciences Corporation:
Breast Cancer
Breast Reconstruction
Perioperative Care
Enhanced Recovery After Surgery
ERAS
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases