Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04306003
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-03-10
Brief Title:
ERAS in Autologous Breast Reconstruction A Pilot RCT
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Hamilton Health Sciences Corporation
Study Overview
Official Title:
Enhanced Recovery After Surgery in Autologous Breast Reconstruction A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERAS-ABR
Brief Summary:
Over 26000 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:
11 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
12 Background and rationale Over 26000 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 patients 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 3715 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 procedures16-18 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 158 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
13 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
12 Background and rationale Over 26000 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 patients 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 3715 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 procedures16-18 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 158 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
13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None