Breast CancerERAS-ABRNCT04306003
ERAS in Autologous Breast Reconstruction: A Pilot RCT
A study testing ERAS pathway and Standard Perioperative Care in people with Breast Cancer, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ERAS pathway and Standard Perioperative Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Nov 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Juravinski Hospital
Hamilton, Ontario
St. Joseph's Healthcare
Hamilton, Ontario
About this study
Official title: Enhanced Recovery After Surgery in Autologous Breast Reconstruction: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- ERAS pathway, Standard Perioperative Care
- Keywords
- Breast Cancer, Breast Reconstruction, Perioperative Care, Enhanced Recovery After Surgery, ERAS
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS pathwayOther
See ERAS pathway arm description.
Standard Perioperative CareOther
See control arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (pertaining to patient eligibility)
Proportion of screened patients who are eligible for the study
Measured: 8-months
Feasibility (pertaining to patient recruitment)
Proportion of eligible patients who are randomized
Measured: 8-months
Feasibility (pertaining to adherence to follow-up assignment)
Proportion of patients with missed assessments and incomplete data variables
Measured: 30 days post-surgery
Feasibility (pertaining to adherence to ERAS protocol)
Proportion of ERAS interventions followed and achieved
Measured: Length of inpatient stay (3 to 7+ days)
Secondary outcomes (6)
Hospital Length of Stay
Cumulative length of hospital stay post-breast reconstruction.
Measured: 1 week
In-hospital opioid consumption
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.
Measured: 1 week
BREAST-Q
Reconstruction module of BREAST-Q (patient-reported outcome) obtained at baseline during preoperative clinic visit and 30-days post-surgery.
Measured: Preop clinic appointment to 30-days post-surgery
EQ-5D-5L
General health-related quality of life measure (patient-reported outcome) obtained at baseline during preoperative clinic visit and 30-days post-surgery.
Measured: Preop clinic appointment to 30-days post-surgery
30-days adverse event (composite outcome)
Proportion of patients experiencing the following event(s):
- Flaps requiring operative salvage or debridement
- Hematoma requiring operative drainage/evacuation
- Surgical site infection requiring hospital admission and IV antibiotic treatment
- DVT
- Pulmonary Emboli
- Cardiovascular event (myocardial injury, stroke, new atrial fibrillation, congestive heart failure)
Measured: 30-days post-surgery
30-days additional resource utilization (composite outcome)
Proportion of patients requiring:
- Visit to ER or Urgent Care
- Hospital readmission
- Additional surgery
Measured: 30-days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start5 Nov 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, Brian Hyosuk Chin, Hamilton Health Sciences Corporation
- Investigators
- Hyosuk Chin, MD, Principal investigator, McMaster UniversityMarko Simunovic, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306003
- Sponsor's protocol ID
- ERAS-ABR
- Acronym
- ERAS-ABR
- Status last verified
- Jul 2020
- First submitted
- 10 Mar 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery in Autologous Breast Reconstruction: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04306003
- Acronym / sponsor ID
- ERAS-ABR / ERAS-ABR
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Reconstruction, Perioperative Care, Enhanced Recovery After Surgery, ERAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) pathway | Experimental | Other: ERAS pathwayPreop 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. |
| Standard Perioperative Care | Active comparator | Other: Standard Perioperative CarePatients in the control arm received routine perioperative care as determined by respective surgeons participating in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS pathwaySee ERAS pathway arm description. | Other | Enhanced Recovery After Surgery (ERAS) pathway |
| Standard Perioperative CareSee control arm description. | Other | Standard Perioperative Care |
Primary outcome
Feasibility (pertaining to patient eligibility)
Time frame: 8-months
Proportion of screened patients who are eligible for the study
Feasibility (pertaining to patient recruitment)
Time frame: 8-months
Proportion of eligible patients who are randomized
Feasibility (pertaining to adherence to follow-up assignment)
Time frame: 30 days post-surgery
Proportion of patients with missed assessments and incomplete data variables
Feasibility (pertaining to adherence to ERAS protocol)
Time frame: Length of inpatient stay (3 to 7+ days)
Proportion of ERAS interventions followed and achieved
6 secondary outcomes
Hospital Length of Stay
Time frame: 1 week
In-hospital opioid consumption
Time frame: 1 week
BREAST-Q
Time frame: Preop clinic appointment to 30-days post-surgery
EQ-5D-5L
Time frame: Preop clinic appointment to 30-days post-surgery
30-days adverse event (composite outcome)
Time frame: 30-days post-surgery
30-days additional resource utilization (composite outcome)
Time frame: 30-days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyosuk Chin, MD principal investigator
McMaster University
Marko Simunovic, MD principal investigator
Hamilton Health Sciences Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS pathway and Standard Perioperative Care in people with Breast Cancer, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (pertaining to patient eligibility) (time frame: 8-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.