Clinical trial NCT04306003: ERAS in Autologous Breast Reconstruction: A Pilot RCT
Official title: Enhanced Recovery After Surgery in Autologous Breast Reconstruction: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Breast Reconstruction
Perioperative Care
Enhanced Recovery After Surgery
ERAS
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2020-03-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility (pertaining to patient eligibility)
timeFrame: 8-months
measure: Feasibility (pertaining to patient recruitment)
timeFrame: 8-months
measure: Feasibility (pertaining to adherence to follow-up assignment)
timeFrame: 30 days post-surgery
measure: Feasibility (pertaining to adherence to ERAS protocol)
timeFrame: Length of inpatient stay (3 to 7+ days)
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: 1 week
measure: In-hospital opioid consumption
timeFrame: 1 week
measure: BREAST-Q
timeFrame: Preop clinic appointment to 30-days post-surgery
measure: EQ-5D-5L
timeFrame: Preop clinic appointment to 30-days post-surgery
measure: 30-days adverse event (composite outcome)
timeFrame: 30-days post-surgery
measure: 30-days additional resource utilization (composite outcome)
timeFrame: 30-days post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Hyosuk Chin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Marko Simunovic, MD
role: PRINCIPAL_INVESTIGATOR
References: