Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.
The grades of recommendations (A-D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.
Key Recommendations
The following recommendations were highlighted by the guideline development group as the key clinical recommendations that should be prioritised for implementation. The grade of recommendation relates to the strength of the supporting evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.
Primary Care and Referral
B - Patients over the age of 40 who present with new onset, persistent or recurrent rectal bleeding should be referred for investigation.
C - Review of the patient by a regional clinical genetics service is recommended for accurate risk assessment if family history of colorectal cancer is the principal indication for referral for investigation.
B - All symptomatic patients should have a full blood count. In cases of anaemia the presence of iron deficiency should be determined.
Diagnosis
D - Colonoscopy is recommended as a very sensitive method of diagnosing colorectal cancer, enabling biopsy and polypectomy.
C - Computed tomography (CT) colonography can be used as a sensitive and safe alternative to colonoscopy.
Surgery
C - Mesorectal excision is recommended for rectal cancers where the patient is fit for radical surgery. The mesorectal excision should be total for tumours of the middle and lower thirds of the rectum, and care should be taken to preserve the pelvic autonomic nerves wherever this is possible without compromising tumour clearance.
C - When an abdominoperineal excision of the rectum is required for very low rectal cancers which cannot be adequately excised by a total mesorectal excision, then an extralevator approach to abdominoperineal excision of the rectum is recommended.
Pathology
B - All reporting of colorectal cancer specimens should be done according to, or supplemented by, the Royal College of Pathologists' minimum data set.
Chemotherapy and Radiotherapy
A - All patients with Stage III colorectal cancer should be considered for adjuvant chemotherapy.
Follow Up
A - Patients who have undergone curative resection for colorectal cancer should undergo formal follow up in order to facilitate the early detection of metastatic disease.
Prevention and Screening
Diet and Excess Weight
Weight
D - Maintaining a body mass index (BMI) close to the lower end of the normal range is advised for the general population to reduce the risk of developing colorectal cancer.
Diet
D - The general population should be advised to:
- Eat at least five portions (400 g or 14 oz) of non-starchy vegetables and fruits each day and to eat relatively unprocessed cereal with every meal
- Keep consumption of red meat to less than 500 g (18 oz) per week and avoid processed meat.
Alcohol
D - The general population should be advised that if alcoholic drinks are consumed they should be limited to no more than two drinks (four units) per day for men and one drink (two units) per day for women.
Smoking
B - The population of Scotland should be encouraged not to smoke, citing decreased colorectal cancer risk as one of the reasons.
Physical Activity
D - Physical activity of at least moderate intensity (equivalent to brisk walking) for a minimum of 30 minutes five days a week is recommended for the whole population (unless contraindicated by a medical condition).
Hormone Therapy
B - The use of hormone replacement therapy specifically to prevent colorectal cancer is not recommended.
Screening
Population Screening
A - Population screening for colorectal cancer using the guaiac faecal occult blood testing (FOBT) should continue in the Scottish population until further evidence on other modalities is available.
Screening and Surveillance of Patients with Inflammatory Bowel Disease
D - All patients with ulcerative colitis or Crohn's colitis of 10 years duration should undergo a screening colonoscopy.
D - Chromoendoscopy with pan-colonic dye-spraying and targeted biopsy of abnormal areas is advised for detecting dysplasia. If chromoendoscopy is not used, 2-4 random biopsies should be taken from every 10 cm of the colon, in addition to biopsies of any suspicious areas.
D - Surveillance colonoscopies should be performed yearly, 3-yearly or 5-yearly according to risk stratification.
D - Colectomy should be performed for high-grade dysplasia, cancer, any dysplasia-associated lesion/mass that cannot be entirely resected endoscopically, and low-grade dysplasia confirmed by two expert gastrointestinal pathologists.
See Table 1 in the original guideline document for optimal surveillance intervals for patients with inflammatory bowel disease.
Surveillance of Patients After Removal of Adenomatous Polyps
D - Patients who have undergone colonoscopic polypectomy for adenomas should be offered follow-up colonoscopy based on risk stratification.
D - Patients with one or two adenomas <1 cm in size without high-grade dysplasia are at low risk and only require follow-up colonoscopy at five years if other factors indicate the need for further surveillance. If no polyps are found, further surveillance is not required.
D The presence of either 3-4 small adenomas (<1 cm), or one adenoma >1 cm in size confers an intermediate risk, and surveillance colonoscopy should be undertaken at three years. If surveillance colonoscopy is subsequently normal on two consecutive occasions, it may cease.
D - Patients with ≥5 small adenomas, or ≥3 adenomas with at least one polyp ≥1 cm in size are at high risk, and should undergo colonoscopy at one year.
The Impact of Colorectal Cancer on Patients and Their Families
Interventions to Alleviate the Impact of Colorectal Cancer
D - Information about local support services should be made available to both the patient and their relatives.
B - Clinicians must be aware of the potential for physical, psychological, social and sexual problems after all colorectal cancer surgery, including sphincter-saving operations.
Methods and Sources of Communication
B - Listening and explaining skills can be improved by high-quality courses, and all healthcare professionals in cancer care should undergo such training.
B - Healthcare professionals in cancer care should consider giving either written summaries or recordings of consultations to people who have expressed a preference for them.
Involving the Patient in the Decision-Making Process
D - Healthcare professionals should respect patients' wishes to be involved when making plans about their own management.
D - Patients should be given clear information about the potential risks and benefits of treatment, in order that they can make choices.
Genetics
B - Individuals at risk or known to be carrying a colorectal cancer (CRC) syndrome gene mutation should be offered colonic screening according to The British Society of Gastroenterology (BSG) and the Association of Coloproctology for Great Britain and Ireland (ACPGBI) guidelines.
See Tables 2 and 3 in the original guideline document for summaries of BSG/ACPGBI recommendations for colorectal cancer screening and surveillance in moderate risk and high risk family groups, respectively.
D - Family history should be used to inform decision making about colonoscopic screening in asymptomatic individuals.
B - All individuals whose family history is suggestive of a CRC syndrome should be referred to a clinical genetics service for consideration of genetic testing to clarify the risk.
Primary Care and Referral
B - Patients over the age of 40 who present with new onset, persistent or recurrent rectal bleeding should be referred for investigation.
D - For patients under the age of 40 with low-risk features and transient symptoms a watch and wait policy is recommended.
C - Review of the patient by a regional clinical genetics service is recommended for accurate risk assessment if family history of colorectal cancer is the principal indication for referral for investigation.
B - General practitioners should perform an abdominal and rectal examination on all patients with symptoms indicative of colorectal cancer. A positive finding should expedite referral, but a negative rectal examination should not rule out the need to refer.
B - All symptomatic patients should have a full blood count. In cases of anaemia the presence of iron deficiency should be determined.
B - All patients with unexplained iron deficiency anaemia should be referred for endoscopic investigation of upper and lower gastrointestinal tracts.
Diagnosis
Endoscopy
D - Colonoscopy is recommended as a very sensitive method of diagnosing colorectal cancer, enabling biopsy and polypectomy.
Radiological Diagnosis
C - CT colonography can be used as a sensitive and safe alternative to colonoscopy.
D - Minimal preparation CT is an alternative to CT colonography in frail elderly patients.
Initial Staging
D - All patients with colorectal cancer should be staged by contrast enhanced CT of the chest, abdomen and pelvis unless the use of intravenous iodinated contrast is contraindicated.
C - Magnetic resonance imaging (MRI) of the rectum is recommended for local staging of patients with rectal cancer.
C - Endoluminal ultrasound (US) can be used in a complementary role with MRI in staging patients with early rectal cancer.
Positron Emission Tomography (PET)
C - In patients with apparently organ-restricted liver or lung metastases (either at primary presentation or during follow up) who are being considered for resection, a PET/CT scan should be considered prior to the administration of cytoreductive chemotherapy. The identification of occult metastatic disease prior to resection or chemotherapy may render resection inappropriate or may alter patient's management.
D - Fluoro-deoxy-glucose (FDG) PET/CT should be used in the evaluation of patients with raised tumour marker carcinoembryonic antigen (CEA) with negative or equivocal conventional imaging or assessment of possible pelvic recurrence and pre-sacral mass following treatment.
Surgery
Preoperative Staging
C - Complete colonic examination by colonoscopy, CT colonography or barium enema should be carried out, ideally preoperatively, in patients with colorectal cancer.
Preoperative Preparation
D - Patients undergoing surgery for colorectal cancer should have:
- Venous thromboembolism prophylaxis
- Antibiotic prophylaxis consisting of a single dose of antibiotics providing both aerobic and anaerobic cover given within 30 minutes of induction of anaesthesia.
B - Preoperative mechanical bowel preparation is recommended for patients undergoing restorative rectal resection.
Perioperative Blood Transfusion
B - If a patient undergoing colorectal cancer surgery is deemed to require a blood transfusion, this should not be withheld on account of a possible association with increased risk of cancer recurrence.
Techniques in Colorectal Cancer Surgery
Rectal Cancer
C - Mesorectal excision is recommended for rectal cancers where the patient is fit for radical surgery. The mesorectal excision should be total for tumours of the middle and lower thirds of the rectum, and care should be taken to preserve the pelvic autonomic nerves wherever this is possible without compromising tumour clearance.
C - When an abdominoperineal excision of the rectum is required for very low rectal cancers which cannot be adequately excised by a total mesorectal excision, then an extralevator approach to abdominoperineal excision of the rectum is recommended.
Colon Cancer
C - It is recommended that colon cancer is treated with radical surgery involving complete mesocolic excision and flush ligation of the colonic vessels.
Anastomoses
C - With a low rectal anastomosis, consider giving a defunctioning stoma.
C - With a low rectal anastomosis after total mesorectal excision (TME), consider a colopouch.
B - After a low rectal anastomosis (i.e., after a TME) a defunctioning stoma should be constructed unless there are compelling reasons not to do so.
Local Excision of Colorectal Cancers
C - The relative risks of operative morbidity and recurrence must be carefully weighed and explained fully to the patient so that an informed decision can be made regarding local excision and rectal cancer.
C - Further surgery for pedunculated polyp cancers that have been removed endoscopically is indicated if:
- There is histological evidence of tumour at, or within 1 mm of, the resection margin
- There is lymphovascular invasion
- The invasive tumour is poorly differentiated
Laparoscopic Surgery for Colorectal Cancer
A - Laparoscopic and open surgery can be offered for resection of colorectal cancer.
Management of Malignant Colonic Obstruction
C - Mechanical large bowel obstruction should be distinguished from pseudo-obstruction before surgery.
C - Patients with malignant obstruction of the large bowel should be considered for immediate resection.
A - If immediate reconstruction after resection is deemed feasible, segmental resection is preferred for left-sided lesions.
B - Where facilities and expertise are available, colonic stenting can be considered for the palliation of patients with obstructing colon cancer, i.e., in those who are not fit for immediate resection or in those with advanced disease. The risk of colonic perforation should be taken into account.
Surgery for Advanced Disease
D - Patients with liver and lung metastases should be considered for resection or, in the case of liver disease, in situ ablation.
D - In patients with advanced local or recurrent disease, careful consideration should be given to surgical excision or palliative intraluminal procedures.
Specialisation and Workload in Colorectal Cancer Surgery
B - Surgery for colorectal cancer should only be carried out by appropriately trained surgeons whose work is audited. Low rectal cancer surgery should only be performed by those trained to carry out TME.
Pathology
Important Pathological Parameters in Colorectal Cancer
B - Pathological reporting of colorectal cancer resection specimens should include information on:
- Tumour differentiation
- Staging (Dukes and tumor-node-metastasis [TNM] systems)
- Margins (peritoneal and circumferential resection margin [CRM])
- Extramural vascular invasion
Reporting in Colorectal Cancer
B - All reporting of colorectal cancer specimens should be done according to, or supplemented by, the Royal College of Pathologists' minimum data set.
Chemotherapy and Radiotherapy
Adjuvant Chemotherapy
Stage III Colorectal Cancer (T1-4 N1,2 M0)
A - All patients with Stage III colorectal cancer should be considered for adjuvant chemotherapy.
Management of Patients with Metastatic Colorectal Cancer
Resectable Liver Metastases
D - Surgical resection should be considered for all patients with resectable liver metastases.
D - Patients with resectable liver metastases should be considered for perioperative chemotherapy with a combination of oxaliplatin and fluorouracil (5-FU)/leucovorin for a total period of six months.
Unresectable Liver Metastases
D - Patients with unresectable liver metastases should be considered for downstaging chemotherapy using a combination of oxaliplatin (or irinotecan) and 5-FU/leucovorin.
First Line Chemotherapy
A - All patients with metastatic colorectal cancer should be considered for chemotherapy.
A - Combination treatment with 5-FU/leucovorin/oxaliplatin or capecitabine and oxaliplatin or 5-FU/leucovorin/irinotecan are the preferred options in patients with good performance status and organ function.
D - Consider raltitrexed for patients with metastatic colorectal cancer who are intolerant to 5-FU and leucovorin, or for whom these drugs are not suitable.
Second Line Chemotherapy
A - Second line chemotherapy should be considered for patients with metastatic colorectal cancer with good performance status and adequate organ function.
A - Irinotecan should be used as second line therapy following first line oxaliplatin (or vice versa).
Biological Therapy
B - Cetuximab should be considered in combination with 5-FU/leucovorin/oxaliplatin or 5-FU/leucovorin/irinotecan chemotherapy for patients with unresectable liver metastases if patients fulfil the Scottish Medicines Consortium (SMC) criteria. The use of cetuximab in combination with oxaliplatin and capecitabine cannot currently be recommended.
Management of Patients with Rectal Cancer
A - Patients considered to have a moderate risk of local recurrence with total mesorectal excision surgery alone, and in whom the CRM is not threatened or breached on MRI, could be considered for preoperative radiotherapy (25 Gy in five fractions over one week) and immediate TME surgery.
A - Patients who require downstaging of the tumour because of encroachment on the mesorectal fascia should receive combination chemotherapy and radiotherapy (biological effective dose [BED] >30 Gy), followed by surgery at an interval to allow cytoreduction.
Follow Up of Patients Treated for Colorectal Cancer
A - Patients who have undergone curative resection for colorectal cancer should undergo formal follow up in order to facilitate the early detection of metastatic disease.
Palliative Care and the Management of Symptoms in Advanced Disease
D - Medical measures such as analgesics, antiemetics and antisecretory drugs should be used alone or in combination to relieve the symptoms of bowel obstruction.
Definitions:
Levels of Evidence
1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias
1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++: High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3: Non-analytic studies, e.g., case reports, case series
4: Expert opinion
Grades of Recommendation
Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.
A: At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D: Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+