Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Central Nervous System Depressants

Antipyretics

Analgesics

Pharmaceutical Solutions

Anti-Inflammatory Agents

Antirheumatic Agents

Ondansetron

Bupivacaine

Acetaminophen

Analgesics, Opioid

Celecoxib

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.

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

ERAS pathway

Standard Perioperative Care

Hyosuk Chin, MD

Marko Simunovic, MD

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.

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.

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.

ERAS in Autologous Breast Reconstruction: A Pilot RCT

Enhanced Recovery After Surgery in Autologous Breast Reconstruction: A Pilot Randomized Controlled Trial

Proportion of screened patients who are eligible for the study

Proportion of eligible patients who are randomized

Proportion of patients with missed assessments and incomplete data variables

Proportion of ERAS interventions followed and achieved

Cumulative length of hospital stay post-breast reconstruction.

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.

Reconstruction module of BREAST-Q (patient-reported outcome) obtained at baseline during preoperative clinic visit and 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.

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)

Proportion of patients requiring:

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

St. Joseph's Healthcare Hamilton

Hamilton Health Sciences Corporation

Principal Investigator

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Adjuvants, Anesthesia

Anticonvulsants

Muscle Relaxants, Central

Psychotropic Drugs

Dexamethasone

Anesthetics

Ropivacaine

Sufentanil

Dexamethasone acetate

BB 1101

Diazepam

Dsuvia

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Narcotics

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Local

Hypnotics and Sedatives

Anti-Anxiety Agents

GABA Modulators

Patients treated with enhanced recovery after surgery protocol: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia with naropin + sufentanil, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV prophylaxis with ondansetron + dexamethasone, hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, postoperative mobilization program, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.

Patients treated with standard care perioperative protocol: epidural analgesia with naropin + sufentanil, pre-anesthetic medication with diazepam, Preoperative bowel preparation with sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4

ERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.

Enhanced recovery after surgery protocol

Epidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4

Standard perioperative care

Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.

PONV prophylaxis with Ondansetron + Dexamethasone

Patient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward

Postoperative mobilization program

Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL

Epidural analgesia with naropin + sufentanil

Pre-anesthetic medication with diazepam

Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.

Preadmission counselling

Preoperative bowel preparation with oral assumption of sodium phosphate

Preoperative bowel preparation with sodium phosphate

Marco Braga, MD

The purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).

A specific enhanced recovery after surgery (ERAS) protocol has been applied since October 2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume Institution. Patient compliance for each item has been assessed. Each ERAS patient was matched with a patient who received standard perioperative care. Match criteria were age, gender, malignant / benign disease, and PD prognostic score.

Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.

Adherence to single items of the pathway.

Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ERAS in Autologous Breast Reconstruction: A Pilot RCT	NCT04306003	Breast Cancer	ERAS pathway Standard Periop...	18 Years -	Hamilton Health Sciences Corporation
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy	NCT01759706	Pancreatic Neop...	Enhanced recove... Standard periop... PONV prophylaxi... Postoperative m... Epidural analge... Pre-anesthetic ... Preadmission co... Preoperative bo...	18 Years - 85 Years	Università Vita-Salute San Raffaele
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy	NCT01759706	Pancreatic Neop...	Enhanced recove... Standard periop... PONV prophylaxi... Postoperative m... Epidural analge... Pre-anesthetic ... Preadmission co... Preoperative bo...	18 Years - 85 Years	Università Vita-Salute San Raffaele

Spots Global Cancer Trial Database for standard perioperative care