Rectal Cancer Surgery - PAN-CANADIAN STANDARDS - MARCH 2019
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PAN-CANADIAN STANDARDS Rectal Cancer Surgery Canadian Society of Colon and Rectal Surgeons MARCH 2019
Colorectal cancer is the second most common cause of cancer death in Canadians, accounting for 12% of all cancer mortality.
CONTENTS INTRODUCTION 10 STANDARDS FUTURE DIRECTIONS 28 AND EVIDENCE 16 Surgeon Criteria 17 Requisite Training and Competency for Practice 17 SCOPE 13 Surgery and Management 18 REFERENCES 29 Practice Settings 20 Organizational Criteria 20 Physical Resources and METHODOLOGY 14 Collaborating Services 23 Human Resources 24 Literature Review and Treatment at Oncology Centres and Relationship with Environmental Scan 15 Affiliated Centres 25 Expert Discussions 15 Quality Processes 26 Data Collection and Continuous Quality Improvement 26
MESSAGE FROM CO-CHAIRS While treating all patients with colorectal cancer can be challenging, the management of rectal 4 DR. CARL J. BROWN DR. CHRISTIAN FINLEY cancer is particularly complicated. 2 Co-Chair, Rectal Cancer Co-Chair, Rectal Cancer Surgery Standards Surgery Standards Provincial Lead, Surgical Oncology, Expert Lead, Clinical Measures, Integration of radiation and chemotherapy, both before and after BC Cancer Canadian Partnership Against Cancer surgical treatment, necessitates coordination across specialties throughout the patient’s cancer journey. Furthermore, innovative treatment techniques have dramatically reduced rectal cancer recurrence, permanent colostomy rates and perioperative pain and suffering. Unlike some other surgically managed cancers, rectal cancer complexity is highly variable at presentation; while some patients may be successfully treated with transluminal surgery alone, others will require neoadjuvant chemoradiotherapy followed by en bloc resection of the rectum with adjacent organs to effect a cure. Therefore, surgeons must collaborate across institutions to ensure that every patient with rectal cancer is managed in the centre that can provide the best care, tailored to their specific cancer, as close to home as possible.
It is our hope that this document will serve Optimal rectal cancer care requires time. Health care planners and providers can as a decision-making resource to support more than the rectal cancer utilize this information to organize care in a the delivery of consistent, high-quality care surgeon; the supporting health care way that maximizes patient outcomes, while to all Canadians requiring rectal cancer team should be well-trained and maintaining reasonable access to care. This surgery. The document provides high-level adequately resourced to provide report is one component of a family of reports guidance and discussion on the foundational timely access to care. to be developed for disease-site specific resources and requirements that need national standards of surgical cancer care. to be in place to improve cancer surgical In particular, there is a heavy reliance on We look forward to working with you to care and outcomes. It is our goal that the timely coordination of diagnostic imaging, improve the quality of complex surgical actionable recommendations included radiotherapy, chemotherapy, surgery, cancer care in Canada. herein will help address current gaps, be pathology and other ancillary recovery forward thinking (serve as a document for and survivorship services whose resource the future) and elevate the delivery of rectal allocation and governance fall to the region Dr. Carl J. Brown cancer surgical care in Canada. Development and institution. As a result, implementation of any standard depends on the successful Co-Chair, Rectal Cancer Surgery Standards of the standards has been informed by collaboration of rectal cancer surgeons with Provincial Lead, Surgical Oncology, BC Cancer environmental scans, literature review and 5 evidence-informed expert consensus. The those disciplines. Dr. Christian Finley document focuses on a number of key areas The document also highlights the Co-Chair, Rectal Cancer Surgery Standards such as the Royal College of Physicians and importance of advanced human resource Expert Lead, Clinical Measures, Canadian Surgeons of Canada’s (RCPSC) system for support, and allied health professionals, Partnership Against Cancer evaluating and formally certifying training. and that manpower planning needs to be The importance of systems of care and comprehensive and systematic to meet devotion of a significant portion of practice targets for care. Quality processes, such as and maintenance of competency to rectal routine data collection and population of a cancer has been highlighted in the document. national database, should be thoughtfully embedded into existing health care processes to catalyze self-evaluation and continuous quality improvement. In addition, careful consideration should be given to regionalizing specialized services for patients with complex rectal cancer to improve patient outcomes, while accounting for patient choice and travel PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
RECTAL CANCER SURGERY EXPERT PANEL MEMBERS Dr. Amanda Fowler Dr. Catherine Streutker Dr. Lara J. Williams Clinical Assistant Professor of Surgery Associate Professor, University of Toronto; Colorectal and Minimally Invasive Surgeon; (Gen Surg), Memorial University, St. John’s, Director of Pathology, Department of Assistant Professor of Surgery, Colorectal and Newfoundland and Labrador Laboratory Medicine, St. Michael’s Hospital; Minimally Invasive Surgery, University Dr. Anthony R. Maclean Project Investigator, Keenan Research Centre of Ottawa, Ottawa, Ontario Chief, Section of General Surgery Calgary for Biomedical Sciences, Toronto, Ontario Dr. Marko Simunovic Zone; Clinical Associate Professor, Dr. Christian Finley (Co-Chair) Professor, Department of Surgery, McMaster Department of Surgery, University of Calgary; Expert Lead, Clinical Measures, Canadian University; Surgical Oncologist, Juravinski President, Canadian Society of Colon and Partnership Against Cancer; Associate Cancer Centre, Hamilton, Ontario 6 Rectal Surgeons; Colorectal Surgeon, Professor, Department of Surgery, McMaster Dr. Michael Ott Foothills Medical Centre, Calgary, Alberta University; Thoracic Surgeon, St. Joseph’s Associate Professor, Department of Dr. Antonio Caycedo-Marulanda Healthcare, Hamilton, Ontario Surgery and Department of Oncology, Associate Professor of Surgery, Northern Dr. David Hochman London Health Sciences Centre, Western Ontario School of Medicine; Colorectal Associate Professor, Department of Surgery, University, London, Ontario Surgery Head, Health Sciences North (HSN); Max Rady College of Medicine, University Dr. Nancy Baxter Clinical Researcher, HSN Research Institute; of Manitoba, Winnipeg, Manitoba Staff Surgeon and Division Chief, Division Surgical Oncology Lead, North East LHIN, Dr. W. Donald Buie of General Surgery, Department of Surgery, Cancer Care Ontario, Sudbury, Ontario Program Director, Colorectal Surgery, St. Michael’s Hospital; Scientist, Keenan Dr. Carl Brown (Co-Chair) Foothills Medical Centre, Calgary, Alberta Research Centre, Li Ka Shing Knowledge Provincial Lead, Surgical Oncology, BC Dr. Erin D. Kennedy Institute of St. Michael’s Hospital; Professor, Cancer; Chair, Section of Colorectal Surgery Colorectal Surgeon, Mount Sinai Hospital; Department of Surgery and Institute of and Clinical Professor of Surgery, University Associate Professor, Department of Surgery Medical Science, University of Toronto, of British Columbia, Vancouver, British and Institute of Health Policy, Management Toronto, Ontario Columbia and Evaluation, University of Toronto, Toronto, Ontario
Dr. Paul Johnson Dr. Selliah Chandra-Kanthan Assistant Professor, Division of General Professor of General Surgery, University of Surgery, Department of Surgery and Saskatchewan, Saskatoon, Saskatchewan Department of Community Health and Dr. A. Sender Liberman Epidemiology, Dalhousie University, Halifax, Colorectal Surgeon; Program Director, Nova Scotia Colon and Rectal Surgery Residency Dr. Raimond Wong Program, McGill University; Associate Radiation Oncologist; Vice Chair, Professor of Surgery and Oncology, McGill Gastrointestinal Oncology Site Group, University, Montréal, Québec Juravinski Cancer Centre, Hamilton Health Dr. Shilo Lefresne 7 Sciences; Associate Professor, Department Radiation Oncologist, BC Cancer, Vancouver of Oncology and Department of Medicine, Centre; Clinical Assistant Professor, McMaster University, Hamilton, Ontario University of British Columbia, Vancouver, Dr. Sami Chadi British Columbia Colorectal Surgeon, Princess Margaret Dr. Stan Feinberg Hospital and University Health Network; Chair, Medical Advisory Committee; Assistant Professor, Department of Surgery, Medical Director, Cancer and Ambulatory University of Toronto, Toronto, Ontario Programs, North York General Hospital, Dr. Sébastien Drolet Toronto, Ontario Chirurgien Général, Spécialiste en Chirurgie Colorectale, Hôpital Saint-François D’Assise, Québec, Québec PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
ACKNOWLEDGMENTS The production of this report was made possible through the dedicated efforts of many individuals. We express our gratitude to them for their contributions and assistance in the development of these recommendations. The Rectal Cancer Surgery The Rectal Cancer Surgery Expert Panel was instrumental in the development of Expert Panel was instrumental in standards through a comprehensive review of academic literature, objective analysis, in- person discussions and document review. We the development of standards would like to acknowledge the contribution of Laura Banfield, Librarian at McMaster through a comprehensive review University, who conducted a comprehensive literature search at the onset of this project. 8 of academic literature, objective In addition, we express our gratitude to the invaluable contributions of the Canadian Society of Colon and Rectal Surgeons (CSCRS) analysis, in-person discussions for their endorsement of this document. Strategic oversight of the development of and document review. this document was provided by the Canadian Partnership Against Cancer (CPAC) by Dr. Craig Earle, Vice-President, Cancer Control. Process development, report production and dissemination were led by the Quality Initiatives, Diagnosis and Clinical Care team at CPAC: Dr. Mary Argent-Katwala, Director; Anubha Prashad, Program Manager; Michele Mitchell, Natasha Camuso, Analysts; and Zahrah Khalid, Delivery Manager.
INTRODUCTION Colorectal cancer is the second most commonly diagnosed cancer in Canada (excluding 10 non-melanoma skin cancers) and represents the second and third leading cause of death from cancer in men and women, respectively.
In 2017, an estimated 14,900 Rectal cancer represents a subset of colorectal appropriate volume threshold to assure “best new cases in men and 11,900 cancers that has particularly challenging care”, most (but not all) population-based new cases in women were technical aspects and management decisions. studies have shown that there are better expected, representing 13% of Despite advancements in surgical techniques outcomes associated with specialization in all new cancer cases.1 and therapies over the years, five-year rectal cancer surgery, greater surgeon-specific survival rates in patients with advanced- procedural volume and surgery performance stage rectal cancers including lymph node at high-volume centres when compared to involvement (IIIC) or those that have spread low-volume centres.8-17 14,900 11,900 to distant sites (IV) are low, at 58% and 12%, respectively.3 On the other end of Rectal cancer surgical quality is important for both perioperative patient safety and to NEW CASES NEW CASES the spectrum, early stage rectal cancer is minimize local recurrence rates. With the increasingly being treated with minimally introduction of total mesorectal excision invasive approaches that improve the (TME) as a standard of care, local recurrence morbidity suffered by patients without rates have significantly decreased.18-22 affecting survival. As with other complex Furthermore, the surgeon’s ability to achieve cancers, the management and outcomes a clear resection margin and complete disease 11 vary considerably. clearance, in some cases requiring multi- The surgical management of patients with visceral resection and/or metastatectomy, rectal cancer is further complicated by the can mean the difference between recurrence heterogeneity of the patient population (age, and disease-free survival in these patients. medical comorbidities, etc.) and multimodal Surgical and hospital volume, as well as treatment options. Despite recent advances appropriate use of neoadjuvant therapy, have in radiation and chemotherapy, surgery been demonstrated to be important with AN ESTIMATED continues to be the primary means of respect to sphincter-preserving surgery.13, 14, 23 curative intent treatment and the optimal For patients with low rectal cancers, optimal 12% delivery of surgical care for these cancers is paramount. Although general surgeons, management and technical excellence are key to avoiding unnecessary permanent of the deaths surgical oncologists and colorectal surgeons colostomies, which are not preferred by the caused by currently perform rectal cancer surgeries, majority of patients. cancer will there is evidence that experience and Beyond the importance of technical be caused specialization in rectal cancer surgery greatly excellence in the provision of TME surgery, by colorectal improve patient outcomes.4-7 While definitions the management options for patients with cancer.1 vary in the literature on what constitutes an PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
rectal cancer have never been so varied. support more intense surgical interventions. Based on the incidence of rectal cancer, The use of radiotherapy in all stage II and III Beyond surgeon expertise in management evidence supporting improved outcomes with rectal cancer patients has been challenged and surgical care, preoperative and post- the aforementioned elements of rectal cancer and may lead to morbidity without benefit.24-27 operative aspects of care are critical to patient care, as well as the disparities in care across In patients with early rectal cancer, minimally outcomes. The benefits of standardized use the country, there is a need for a set of pan- invasive local excision techniques, with or of pretreatment staging with CT scan and Canadian standards to ensure consistent, high- without adjuvant therapy, are acceptable for magnetic resonance imaging (MRI) (with quality care for all Canadians requiring rectal select patients.20, 28-30 Furthermore, in some expert standardized interpretation and cancer surgery. As such, this document seeks locally advanced rectal cancers, non-operative reporting), multidisciplinary conferences to support surgeons committed to treating management is under investigation for patients for treatment planning, and standardized patients with rectal cancer by highlighting for whom a complete clinical response is pathology reporting, have been clearly the features of a facility treating rectal cancer achieved.18-20, 31, 32 The importance of evidence- demonstrated. Appropriate facilities and patients, and the quality processes needed to based rectal cancer management has never resources are also needed to ensure all elevate the delivery of high-quality care in the been more critical, and it is usually the surgeon Canadian surgeons have timely access to these contemporary Canadian context. who is the patient’s first contact and facilitates critical aspects of comprehensive cancer care. 12 their multidisciplinary care. In this context, it is clear that surgical and institutional capabilities required by patients presenting with rectal cancer vary markedly. There is a need for a set of pan-Canadian standards to As such, this document distinguishes patients with complex rectal cancer and defines some of the special resources, both with respect to the team of surgeons often required for their care and the institutional commitment necessary to ensure consistent, high-quality care for all Canadians requiring rectal cancer surgery. Introduction
Scope THE SCOPE OF THIS DOCUMENT THE SCOPE OF THIS DOCUMENT INCLUDES: DOES NOT INCLUDE: • Rectal cancer surgery, with emphasis • Colon cancer care on resources and personnel required for • Management of care pathways comprehensive rectal cancer care by cancer type or tumour site • Timely access to care from a pre-, peri- and • Assessment of drugs and post-operative perspective treatment options • Training and maintenance of competencies • Facilities and resources for for rectal cancer surgeons provision of radiation and • Access to services and equipment medical oncology treatment 13 • Access to medical oncologists, radiation • Assessment of technology and oncologists, pathologists, other physicians equipment used to deliver care and allied health professionals • Resources for patients and families • Quality processes, including multi- disciplinary tumour board rounds • Distinguishing tiers of complexity in patients with rectal cancer and defining appropriate centres for their management PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
METHODOLOGY The standards herein were developed through consultation with an expert panel of 14 rectal cancer surgeons from across Canada.
FIGURE 1 Literature Review and Flow chart of search results Environmental Scan and article inclusion A literature search was performed using Surgical Embase and Surgical Medline, restricted to publications between 1974 to May 2017 and 1946 to June 2017, respectively. A comprehensive INITIAL search strategy was developed to assess the literature to examine RESEARCH evidence. The search strategy incorporated medical subject headings (MeSH), Boolean operators and wild cards. Results were 10,564 6,864 (Surgical Embase) 3,700 (Surgical Medline) excluded if they were duplicate findings or were not deemed relevant after review (Figure 1). TITLES AND ABSTRACTS REVIEWED FOR RELEVANCE 8,632 1,932 15 DUPLICATES Expert Discussions REMOVED The standards herein were developed through consultation INITIAL LITERATURE with an expert panel of rectal cancer surgeons from across SEARCH Canada. The expert panel members reviewed literature search findings for relevance and identified key evidence to 271 be evaluated and incorporated to support the standards, 8,631 where appropriate. An in-person meeting was held to develop ARTICLES standard statements (40 standards were developed) and achieve DEEMED NOT RELEVANT consensus on standard statements to be included, followed by an electronic survey to validate and vote on the results from the in-person meeting. Based on the electronic survey, 41 standards were included in this document. A targeted review period was held to seek endorsement from the Canadian Society of Colon ARTICLES INCLUDED IN and Rectal Surgeons (CSCRS), which was achieved. FINAL REVIEW 49 PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
STANDARDS AND EVIDENCE The technical skills and knowledge to safely and competently conduct rectal surgery requires 16 that the practitioner has completed comprehensive training in the full scope of rectal cancer surgery.
Surgeon Criteria The technical skills and knowledge to 1.1 REQUISITE TRAINING AND COMPETENCY FOR PRACTICE safely and competently conduct rectal surgery require that the practitioner has 1.1.1 A rectal cancer surgeon is a general training and hold formal certification in completed comprehensive training in the surgeon who has contemporary colorectal surgery or surgical oncology full scope of rectal cancer surgery.33 It is knowledge of the diseases of the colon, with qualification by the RCPSC. For acknowledged that surgeons conducting rectum and anus in adults as defined by those not trained in Canada, a similar rectal cancer surgeries often start and/or the Objectives of Training in the specialty regimented and accredited training continue their practice in general surgery; of General Surgery by the Royal College program must be completed. For general however, as rectal cancer management, of Physicians and Surgeons of Canada surgeons without colorectal surgery including both appropriate use of multimodal (RCPSC) and who continues to acquire or surgical oncology certification, treatment and the technical conduct of the such knowledge through Continuing expertise developed through a focused surgery, is constantly evolving and can be Medical Education (CME) and a sufficient commitment to the treatment of complicated, advanced skills and knowledge 17 volume of practice.33 “complex” rectal cancer may substitute are required. Surgeons whose training is for the above qualification. obtained outside of Canada should utilize the 1.1.2 A rectal cancer surgeon should have appropriate RCPSC avenue for evaluation and complete training and hold formal 1.1.4 A rectal cancer surgeon’s participation credentialling when possible. Certification certification in general surgery and have in the maintenance of certification is by the RCPSC is not mandatory if all other significant expertise/interest in rectal mandatory and must be in accordance criteria of expertise as a rectal cancer cancer surgery. For those not trained with provincial and national standards. surgeon are met. in Canada, a similar regimented and 1.1.5 A rectal cancer surgeon should perform accredited training program must be It is imperative that rectal cancer surgeons rectal cancer surgery as a regular part completed and certified. regularly maintain and update their skills and of their practice and commit regular knowledge and devote a significant amount 1.1.3 A subspecialty rectal cancer surgeon, CME time specifically to rectal cancer of time to the practice to ensure maintenance in addition to the criteria for a rectal to maintain competency. of competency in rectal cancer surgery. As the cancer surgeon, will have complete field advances, rectal cancer surgeons need to keep up to date with contemporary standards and evolving evidence to ensure that patients PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
are receiving optimal care. Surgeons should maintain expertise and competence through 1.2 SURGERY AND MANAGEMENT ongoing education in Continuing Profesional Development programs, such as the 1.2.1 All patients with rectal cancer should • Rectal cancer in a patient with a prior pelvic Maintenance of Certification program of the be evaluated by a rectal cancer surgeon cancer requiring surgery or radiation therapy RCPSC. Routine CME is considered a necessary early in the care process, prior to the • Rectal cancer in a patient with previous factor to maintain best patient outcomes. initiation of chemotherapy and/or rectal or left-sided colon surgery radiation therapy. • Rectal cancer that has been previously While expert technical skills are required locally excised and requires subsequent for surgeons who are conducting rectal 1.2.2 While the majority of mid- and upper completion proctectomy surgeries, appropriate systematic evaluation rectal cancers are appropriate for 1.2.3 A subgroup of rectal cancer patients and patient support systems are also treatment at any rectal cancer surgery with “early rectal cancer”, defined as essential for optimal patient outcomes. centre, there is a recognized subgroup T1 lesions with favourable pathology, Regardless of the level of training or of “complex rectal cancer” patients who can be treated by transanal techniques experience of a surgeon, it is clear that best should be offered assessment and with avoidance of radical resection. care for patients with rectal cancer may not possible treatment in a referral centre While this treatment is not equivalent 18 be possible if the institution and community for complex rectal cancer surgery. to total mesorectal excision with respect in which the surgeon practices do not have Complex rectal cancers include but are to recurrence, there is no apparent access to the technology, personnel and not limited to: cancer-specific survival compromise in equipment required for surgical treatment. • The majority of rectal cancers where these patients. Patients with early rectal All centres treating rectal cancer patients abdominoperineal resection is planned cancer who are candidates for local should participate in provincial/regional • Rectal cancer where the main tumour excision should be offered assessment at networks of care to ensure that all patients transgresses the mesorectal or mesosigmoid radial margin, has a positive/suspicious a Transanal Endoscopic Surgery Centre are treated in an appropriate location that mesorectal node, or a tumour deposit. and reviewed at a Multidisciplinary meets the standards herein. For patients with • Rectal cancer invading adjacent organs (T4) Cancer Conference (MCC) before and complex rectal cancer, it is ideal that these and thus requiring multivisceral resection after treatment.6 patients be offered treatment at referral centres, which will be defined and discussed • Rectal cancer in patients with a hereditary 1.2.4 Rectal cancer surgeries should be cancer syndrome (e.g., Lynch Syndrome in section 1.2 of this document. Hereditary Non-Polyposis Colon Cancer performed in centres that are compliant (HNPCC), Familial Adenomatous Polyposis) with the needs defined by this document. • Recurrent rectal cancer While a clear surgery volume threshold has not been established, the association • Rectal cancer in a patient with synchronous pelvic malignancy (e.g., prostate, uterine, etc.) between surgeon/hospital procedural Standards and Evidence
volume and rectal cancer outcomes All patients with rectal cancer in Canada should be evaluated in a systematic suggests that the rectal cancer surgeon and comprehensive way, such that care can be standardized and key decision- should have a focus on rectal cancer makers are consulted prior to treatment initiation. surgery in their practice. Furthermore, there should be sufficient hospital volume to optimize the care among Within this model, rectal cancer surgeons preservation) and radiation treatment allied health care providers.6-8, 10, 16, 17, 34, 35 have an early and primary role in the approaches. Additionally, all patients with diagnosis and decision-making process metastatic disease who would otherwise 1.2.5 All patients with rectal cancer should before other treatment options have be fit for curative intent treatment should have access to an MCC. All patients been initiated. MRI is a key be evaluated and discussed with respect to should be discussed in an MCC and have component of preoperative potential radical therapies.36 the conclusions recorded as part of the care for rectal cancer patients It is the opinion of the expert panel that patient record.36 to help with staging and not every general surgeon in Canada will 1.2.6 Surgeons treating rectal cancer surgical planning, as well as maintain individual volume and technical should have experience in and training identifying patients that may expertise, or has the institutional support for total mesorectal excision benefit from preoperative therapy. required to perform rectal cancer surgery 19 (TME) surgery.37 While all patients should ideally be at a level currently accepted as standard 1.2.7 Cross-sectional imaging of patients discussed at an MCC, the expert panel care. Therefore, collaboration among with rectal cancer should be reviewed recognizes there are currently practical surgeons to determine focused local by an expert radiologist in consultation limitations to this access. In many expertise for uncomplicated rectal cancer is with a surgeon who performs rectal settings, patients are selectively discussed encouraged. Furthermore, all patients with cancer surgery. at an MCC. However, upon request, all complex rectal cancer should have timely 1.2.8 Patients with a good performance status patients should have access to evaluation access to institutions with the surgeons, and low-volume metastatic rectal cancer at an MCC and the recommendations of personnel and resources to provide them disease should be presented at an MCC the forum shared with them to inform the best care. In a given region, good with possible referral to a hepatic- their treatment decisions. All MCC results communication and collaboration among pancreatic-biliary (HPB) surgeon, should be documented in the patients’ all surgeons providing care to patients thoracic surgeon or radiation oncologist charts. Key elements for discussion with rectal cancer are necessary to ensure (for stereotactic body radiation therapy), should include intent of treatment (cure optimal patient outcomes at a regional where appropriate. versus palliation), coordination and timing level.36 of adjuvant and neoadjuvant therapy, surgical approaches (resectability, sphincter PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
Practice Settings 2.1 ORGANIZATIONAL CRITERIA 2.1.1 The initial treatment (surgery conducted or chemotherapy and/ 2.1.3 Rectal cancer surgery should be performed in a “Rectal Cancer or radiotherapy started) for 90% of rectal cancer patients should Surgery Centre”, defined as providing appropriate facilities, be initiated within six to eight weeks of the date of biopsy. including the following resources: Appropriate referrals and investigations should be made as Expert physician care Perioperative planning services early as possible. It is the joint responsibility of the institution, • At least one rectal cancer surgeon • Timely access to CT, MRI, ERUS region, surgeon and health care team to coordinate care in a • On-site pathologist (for • Timely access to radiation and timely manner, and resources should be applied appropriately frozen section) and access to medical oncology assessment to ensure time frames are met. pathologist with experience and and treatment expertise in the Quirke method • Preoperative assessment clinic 2.1.2 Pathology reporting time should be tracked and cases should be of TME assessment with anesthesia, nursing, ET 20 reported within two weeks with appropriate resourcing. • Anesthesia support, including nurse assessment 24-hour access Access to care and timeliness of evaluation significantly impact Allied health care services • Access to radiologist with expertise • Enterostomal therapist a rectal cancer patient’s journey.38 The expert panel has in MRI and CT for rectal cancer • Dietary and nutritional support defined appropriate time frames for care. These targets are the • Access to interventional radiology • Physical therapy mutual responsibility of the surgeons, oncologists and other • Access to urologist • Home care and social work disciplines with direct responsibilities to the patient and the Medical support system • Wound care service facility. Not all patients will move through the system seamlessly, for major complications of abdominal surgery Postoperative support services particularly because of the required radiologic imaging and • Access to cancer support networks • Intensive care and/or high- multidisciplinary nature of rectal cancer treatment, and these dependency care unit • Timely access to medical targets have accounted for reasonable delays related to these • Access to CT scan with oncology and genetic counselling challenges. Efforts need to be focused on providing timely care interventional capability so that delays in the process of evaluation and treatment do not • Access to rapid response have a negative impact on patient care and prognosis. Active laboratory (i.e., biochemistry, cytology, hematology, monitoring of contributory wait times (e.g., pathology reporting, transfusion and microbiology) clinical appointments, imaging, Operating Room booking, etc.) is services 24 hours a day essential to ensure that unacceptable delays are acted upon and appropriate policies put in place to motivate responsible parties. Standards and Evidence
2.1.4 All rectal cancer patients with “complex 2.1.5 “Referral Centres for Complex Rectal 2.1.6 Appropriate early-stage rectal cancer rectal cancer” should be assessed at Cancer Surgery” should meet all criteria patients should be assessed at a a “Referral Centre for Complex Rectal for a “Rectal Cancer Surgery Centre”, “Transanal Endoscopic Surgery Centre”. Cancer Surgery”. These centres should and additionally provide: This may be co-located at “Rectal meet all criteria of a “Rectal Cancer Expert physician care Cancer Surgery Centre” or “Referral Surgical Centre”, and additionally have • At least two subspecialty rectal cancer surgeons Centres for Complex Rectal Cancer surgical capabilities and unique services • Access to pathologist with experience and Surgery” and provide additional required to address the specific needs expertise in the Quirke method of TME services as follows: assessment of these complex cancer patients (e.g., Expert physician care • Urologist with expertise in cystectomy/ requiring multivisceral resection or reconstruction (at sites where pelvic • At least one rectal cancer surgeon with abdominoperineal resection, etc.). It is exenteration is performed) advanced training/expertise in one of the transanal endoscopic surgery (TES) platforms recognized that all provinces/regions • Orthopedic oncologist or neurosurgeon capable of sacrectomy, with expertise in resection of • These platforms include, but are not may not be able to offer these services limited to, Transanal Endoscopic orthopedic malignancies (at sites where rectal 21 and interprovincial relationships need Microsurgery (TEM), Transanal Endoscopic cancers with concomitant sacrectomy/bone to be established. Furthermore, not resection is performed) Operation (TEO) or Transanal Minimally every “Referral Centre for Complex Invasive Surgery (TAMIS) techniques • Plastic surgeon with experience/expertise in Rectal Cancer Surgery” will have pelvic floor reconstruction • Access to a pathologist with experience and expertise in evaluating local excision expertise/capacity to manage every Medical support system for major complications of abdominal surgery specimens, including documentation of all patient with “Complex Rectal Cancer”; factors known to influence the need for • Intensive care unit and high-dependency care multiple centres (with geographic immediate radical resection (e.g., depth of unit with experience managing complex pelvic accessibility considerations) should cancer invasion, lymphovascular invasion, surgery patients tumour budding, margin status, etc.) manage some or all of these patients in • Regional/provincial recognition of funding collaboration, depending on the mix of necessary to manage complicated rectal Postoperative support services cancer patients • Access and experience with rigorous expertise/capacity at each centre. follow-up not typical of rectal cancer treated by radical resection 2.1.7 Transitions between most responsible physicians must be clearly articulated and documented and transfers of care confirmed. PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
2.1.8 All rectal cancer centres should set targets to monitor and and increased collaboration with multidisciplinary teams. These evaluate wait times and timely access to care. factors have been shown to reduce the need for reoperation, Rectal cancer surgeries should be performed in institutions reduce local recurrence and improve long-term survival.8, 10, 39 with the appropriate facilities and resources to ensure optimal Due to the unique needs of early-stage rectal cancer patients patient outcomes, as outlined above.4, 8 Expert and experienced and the specialized equipment used for the care of this surgeons may be capable of delivering exceptional care, but in population, procedures must be performed at a rectal cancer the absence of key facilities and resources, patients could be centre equipped to deliver this specialized care where both the put at risk. In these cases, it is important that institutions have procedure and the pathologic considerations are addressed. relationships in place to continue to deliver care to patients to This can be at any rectal cancer centre that has the appropriate ensure they are not adversely impacted. facilities and trained staff and may or may not be co-located at a All rectal cancer cases that are complex or advanced (as per “Referral Centre for Complex Rectal Cancer Surgery”. criteria detailed in section 1.2.2) require additional 2.1.9 Rectal cancer surgeons should participate in regionally and expertise and resources. In these cases, patients should be provincially integrated and established networks of care to ensure referred to centres with advanced expertise, experience, appropriate care is provided as close to home as possible. resources and facilities to deal with complex rectal cancer cases. Geographic isolation, particularly within the Canadian context, 22 These centres should meet the criteria outlined for “Referral can prohibit the delivery of high-quality care to vulnerable Centres for Complex Multivisceral Rectal Cancer Surgery” when a populations. Availability of a functional network of care, multivisceral resection may be required. As these patients often including ready access to telehealth and other technological require surgical teams, there should be a minimum of two highly- solutions, can help mitigate the deficiencies and provide care trained subspecialty rectal cancer surgeons with appropriate closer to home. Thus, regionalization of services should take expertise on staff in these centres to provide diagnostic into consideration patient choice and the distance that patients assessment and management of advanced rectal cancer surgical are willing to travel, as these patients often need ongoing issues. While there are no clinical trials or scientific studies that health care services.40, 41 Innovative regional programs that are able to determine when to add additional surgeons beyond leverage existing networks are important to ensure that patients a minimum of two, real-world evidence and local expert opinion get optimal care. Whether through diagnostic assessment should be sought to maintain a high level of quality care based pathways, integrated home care models or active involvement on access. Clinical workload in these centres, which often goes of the patient’s primary care team, many existing programs can beyond rectal cancer care, can rapidly increase the need to recruit bridge these potential care gaps. additional surgeons. These centres should also have appropriate infrastructure, including experienced nursing and allied health care providers on patient units, operative resources to meet the needs of patients outside the hospital’s immediate community, Standards and Evidence
2.1.10 Infrastructure should be in place to support the participation of patients in 2.2 PHYSICAL RESOURCES AND COLLABORATING SERVICES clinical research. Infrastructure, such as the availability 2.2.1 MRI should be protocolled correctly evidence and safety procedures and of disease-specific clinical trial for rectal cancer staging, read by assess the delivery of high-quality care networks, should be in place to an experienced GI radiologist and and patient outcomes.45 support and increase the participation reported in a synoptic format within 2.2.3 All rectal cancer patients who will of patients in clinical research. For two weeks from the requisition. receive a planned stoma and those treatment of rectal cancer, particular 2.2.2 Rectal cancer pathology, gross who have a possibility of receiving a focus should be given to availability evaluation and processing of the stoma should be referred to a qualified and funding of clinical trials, as this specimen should be done by the enterstomal nurse and/or enterstomal disease is under-resourced relative to Quirke method and should be reported therapy nurse (ETN) prior to surgery its mortality and incidence. by the College of American Pathologists for pre-op counselling, education (CAP) rectal cancer synoptic report regarding care and management of within two weeks. All patients stomas, and marking. 23 should have access to reflex-relevant • All rectal cancer patients who have a stoma immunohistochemistry/biomarker should be provided with information about the peer and community-based supports testing, including mismatch repair for ostomy patients (e.g. United Ostomy proteins (preferably reflex testing).42-44 Association of Canada peer support program) before surgery or prior to discharge if All rectal-related MRI and pathology unplanned.37 reports should be reported in a synoptic format within two weeks 2.2.4 Patients with clinical or historical from completion, ideally using an factors consistent with high risk of electronic interface. Electronic hereditary malignancy should have synoptic reports are standardized access to appropriate genetic testing checklists that capture information at in accordance with established the point of care and, once completed, guidelines, as well as access to genetic can be transmitted to other health counselling services. care professionals and central All patients with suspected hereditary quality assurance data repositories.45 malignancies should be referred for Captured information can be used appropriate genetic testing and/or by surgeons to assess adherence to reflex testing to ensure appropriate PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
treatment and follow-up care. Access to genetic counselling services for these 2.3 HUMAN RESOURCES patients is also important and the referral should be made in a timely manner. 2.3.1 The MCC should consist of health care. Human resource planning should be 2.2.5 All cancer centres should have well- professionals with expertise/interest in comprehensive and systematic; thought maintained and adequately resourced GI cancers, including but not limited to: has to be put into the composition of the equipment and facilities. • Rectal cancer • Radiation oncologists team (i.e. full-time equivalence, etc.) with surgeons • Pathologists clear emphasis that this is a team sport. 2.2.6 Capital expenditures must be available • Medical oncologists • Radiologists to provide contemporary equipment Attendance at MCC is mandatory, with Surgeons treating rectal cancer and be re-evaluated when there are one representative from each specialty. must participate in multidisciplinary changes in the workforce and evolving conferences via telemedia, virtually Collaboration and knowledge-sharing standards of care. or in person. are essential for those involved in patient care. Collaboration between and within Ensuring regular maintenance of 2.3.2 All rectal cancer patients should be offered specialties has been shown to enhance equipment and adequate resourcing screening for and management of distress patient outcomes and significantly reduce 24 is important to deliver exceptional shortly after diagnosis and at key transition the time from diagnosis to treatment.49-51 It is patient care. Upfront budgeting points (e.g., initiation of neoadjuvant critical that radiologists, medical oncologists, and resourcing should be taken into therapy, preoperatively, adjuvant therapy, radiation oncologists and surgeons formulate consideration in planning.46, 47 As end of treatment).37 a unified, evidenced based management needs are constantly evolving, it is Critical to successful patient care is the plan for patients. Timely communication vital to monitor and evaluate in order team involved in managing the care. Rectal within multidisciplinary teams is necessary to respond to changing needs. cancer surgeons recognize that while their to ensure compliance with agreed-upon role as the surgeon is one of leadership, patient pathways, including personalized knowledge and technical excellence, the case management and compliance with entire care team contributes to prevention definitive treatment.10, 48 of mortality and morbidity and rescue from A systematic and comprehensive plan should adverse events. “Failure to rescue” in the be in place to ensure that all rectal cancer broader sense is an institutional failing as patients are regularly screened for signs of much as a physician one.48 Although the distress. This will help to measure the patient rectal cancer surgeon has an integral role, journey and ensure that they are coping well collaboration with other specialties, with their diagnosis and treatment. Patients consultants and clinical nurse specialists showing signs of distress should receive is key to providing high-quality surgical timely, appropriate support. Standards and Evidence
2.4 TREATMENT AT ONCOLOGY CENTRES AND RELATIONSHIP WITH AFFILIATED CENTRES 2.4.1 All rectal cancer centres should have a relationship with a cancer centre with access to consultation from medical and radiation oncologists. There should be a mechanism in place to provide urgent consultation and treatment for in-patients. For services not immediately available in the institution, knowledge and/or formal relationships with centres that can provide these services in the region are important. Barriers in geography or available beds should 25 not impede the necessary consultation or treatment. Although a rectal cancer centre should be equipped with adequate resources to manage the full range of rectal cancer surgical care, if this is not the case, a formal working relationship or association with a regional cancer centre should be in place.34, 38 This includes affiliation with a regional cancer centre that has access to radiation therapy equipment, and where consultation with medical and radiation oncologists is also readily available. PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
Quality Processes 3.1 DATA COLLECTION AND CONTINUOUS QUALITY IMPROVEMENT 3.1.1 Institutions and regions that have regional high-quality care. Funding, capturing 3.1.7 There is an expectation that techniques cancer centres need to support quality and coordinating this process is the and processes of care will change processes such that financial barriers are responsibility of health authorities in over time. Adoption should be done not a limitation to participation. order to provide appropriate supports in a systematic manner to support 3.1.2 Regional authorities should collect and governance to institutions to standardized implementation with a relevant quality marker data for achieve best practices.53, 54 need for credentialling where significant audit and feedback intervention 3.1.4 Patient education should be conducted changes in technologies and approaches in collaboration with rectal cancer in accordance with the institutional/ are introduced. When adopting new surgeons, and coordinate with provincial education standards for adults technologies and techniques, active 26 national efforts.5, 52, 53 affected by cancer.37 tracking of adverse events and outcomes should be completed. 3.1.3 There should be implementation of 3.1.5 It is the joint responsibility of the a national, data-driven approach to regional cancer centres and rectal 3.1.8 National, provincial and institutional deliver best practice care. Routine cancer surgeons to actively monitor organizations should identify patients data collection on process and patient complications and for at high risk for negative outcomes, outcomes should be systematically human resources to have quality in particular those from vulnerable and prospectively captured and processes in place to support quality populations, and develop appropriate benchmarked against national and improvement. Every regional cancer pathways and monitor compliance with international standards. This includes centre needs to have a system in them.54 systematic classification of adverse place to identify adverse events and 3.1.9 At the completion of active treatment, events, regular review of morbidity and outcomes early in the patient’s journey patients should have structured, systematic mortality rounds, and periodic review and rescue the patients to avoid further, and comprehensive surveillance and of data to allow for self-evaluation more serious events. access to survivorship resources. and to promote continuous cyclical 3.1.6 Institutions should support adequate improvement (through audit and collection and measurement of patient feedback). Best practice approaches experience data (e.g., patient-reported should be utilized and shared to ensure outcomes, wait times). Standards and Evidence
Although difficult to precisely define, quality improvement is often measured by components of structure, outcomes and processes. One way for rectal cancer surgeons to evaluate have been shown to improve outcomes. their practices is to compare themselves with Institution-level data should be fed back into evidence-based national guidelines.55 Data the system to improve quality and minimize about quality care, process and outcome interprovincial barriers, as well as to local measures can provide meaningful information participants providing rectal cancer surgical regarding surgical outcomes and quality.53 services to help improve quality. Monitoring Regular monitoring of data can help predict outcome data can help clinicians identify surgical morbidity and mortality. Over time, which processes they have followed, or not, routine collection of data will improve data that have directly impacted patient outcomes. quality and lead to better patient care. In Canada, an eight-centre pilot program was However, outcomes not only depend upon designed to improve clinical outcomes for surgeon and hospital volume, but also can patients by implementing quality initiatives 27 depend on surgical technique, patient factors for rectal cancer across the country. (e.g., comorbidities) and multidisciplinary Supported by the Canadian Partnership treatment decisions.39 Data collection at various Against Cancer and led by Dr. Erin Kennedy, points of the patient journey and benchmarking this program demonstrated improved against national and international standards/ adherence to standards over the duration targets can support the delivery of high-quality of the two-year project (see http://www. patient-centred care. rcacprojects.ca/?page_id=15). Ongoing data The goal of data collection, evaluation and collection with iterative feedback to treating monitoring is to help improve surgical and clinicians is an important quality assurance hospital performance in a non-punitive tool in rectal cancer care. manner and to steer away from a “blame Recognizing that there is considerable variation and shame” approach. When adopting new in the evaluation of quality of care, techniques or technologies, risk to patients the uniform use of well-defined needs to be balanced against the amount quality of care indicators to measure and significance of the innovation. Review and monitor performance holds the and regular audit of data and monitoring promise of improving outcomes in of complications in a standardized way patients who undergo rectal surgeries. PAN-CANADIAN STANDARDS FOR RECTAL CANCER SURGERY
FUTURE DIRECTIONS This document is intended to serve as an informational and decision-making resource to elevate and standardize 28 the delivery of rectal cancer surgery in Canada. Following publication, future work will include wide dissemination and identification of strategies to catalyze systematic and comprehensive adoption to help narrow the gap and address current deficiencies and variability in care. Efforts are underway to develop an evaluation framework to measure uptake and to explore the role of CSCRS and Accreditation Canada as a mechanism to promote and offer accreditation processes to enforce the recommended standards.
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