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.
Prevention and Screening
Diet and Excess Weight
B - The population of Scotland should be advised to maintain a body mass index of 18.5-25 kg/m2 throughout life.
C - Individuals in Scotland should be advised to eat five or more portions of fruits and vegetables a day, in line with the current guidance from the Health Education Board for Scotland.
B - The population of Scotland should be encouraged to take at least 30 minutes of physical activity (such as brisk walking) on most days, citing decreased colorectal cancer risk as one of the reasons.
B - The population of Scotland should be encouraged not to smoke, citing decreased colorectal cancer risk as one of the reasons.
B - The use of hormone replacement therapy specifically to prevent colorectal cancer is not recommended.
D -
- Patients with left-sided colitis or pancolitis of 10 years duration should undergo three yearly colonoscopy with mucosal biopsies and biopsy of any suspicious lesions.
- The frequency of examination should increase to yearly when the disease has been present for 20 years, or when indeterminate dysplasia has been diagnosed.
D - Colectomy should be performed for high grade dysplasia, and considered for low grade dysplasia.
D -
- Patients who have undergone colonoscopic polypectomy for adenomas should be offered follow up colonoscopy.
- If one or two adenomas <1 cm are found at colonoscopy, a repeat colonoscopy should be performed at five years. If this is normal, colonoscopic surveillance may cease.
- If there are three or more adenomas, or at least one >1 cm, or at least one showing severe dysplasia, repeat colonoscopy should be performed at three years. If surveillance colonoscopy is subsequently normal on two consecutive occasions, it may cease.
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 audio-tapes 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
Family History of Colorectal Cancer
C - A three generation family history should be taken from all individuals with colorectal cancer.
D - Individuals at moderate risk of developing colorectal cancer on the basis of their family history should be offered a single colonoscopy at 30-35 years and again at 55 years.
Table 1 in the original guideline document provides criteria for screening individuals at risk of colorectal cancer by risk level (e.g., high, moderate, low)
Individuals with a High Risk Family History of Colorectal Cancer (Including Hereditary Non-polyposis Colorectal Cancer [HNPCC])
C - Referral of individuals with a high risk of developing colorectal cancer should be made to the local clinical genetic service for consideration of mismatch repair gene mutation analysis.
C - Individuals carrying a mismatch repair gene mutation or fulfilling high risk criteria for HNPCC should be offered endoscopic screening starting in the twenties if possible and repeated every two to three years, taking into account the patient's general condition and uptake.
Familial Adenomatous Polyposis (FAP)
C - Patients with clinically diagnosed FAP should be referred to the local clinical genetic service for APC gene mutation analysis.
C - Individuals at risk of FAP, determined either by a positive family history or on the basis of mutation analysis, should be offered colonoscopy every two to three years and yearly sigmoidoscopy.
C -
- Patients with FAP should be offered proctocolectomy with or without ileoanal reconstruction or total colectomy with ileorectal anastomosis once adenomas have developed.
- Subsequent management should include lifelong surveillance of the residual rectum where appropriate and regular upper gastrointestinal endoscopy to detect duodenal adenomas or malignancy.
Primary Care and Referral
Important Symptoms of Colorectal Cancer
C - Patients over the age of 50 years with any of the following symptoms over a period of six weeks should be urgently and appropriately investigated:
- Rectal bleeding with a change in bowel habit to looseness or increased frequency
- Rectal bleeding without anal symptoms
- Palpable abdominal or rectal mass
- Intestinal obstruction
C - All patients with iron-deficiency anaemia (Hb <11g/dl in men or <10g/dl in postmenopausal women) without overt cause should be thoroughly investigated for colorectal cancer.
Strategies to Reduce Delay in Diagnosis of Colorectal Cancer
D - Patient groups at risk of colorectal cancer, especially those over 50 years of age, should be informed about significant symptoms and encouraged to seek medical attention early should they develop such symptoms.
D - General practitioners should perform a thorough abdominal and rectal examination on all patients with symptoms suspicious of colorectal cancer.
D - When a patient presents with suspicious symptoms or signs, they should be urgently investigated and referred to a surgical unit with a declared interest in colorectal cancer.
Diagnosis
Endoscopy
D - Colonoscopy is recommended as a very sensitive method of diagnosing colorectal cancer, enabling biopsy and polypectomy.
Double Contrast Barium Enema
B - Double contrast barium enema may be employed as a sensitive, safe alternative to colonoscopy.
B - Where the sigmoid colon is not well visualised, e.g., in the presence of severe diverticular disease, double contrast barium enema should be combined with flexible sigmoidoscopy.
Computed Tomography (CT) Pneumocolon
D - Where the radiological expertise and equipment exist, a CT pneumocolon is recommended as a sensitive test for colorectal cancer.
Surgery
Preoperative Staging
B -
- All patients undergoing elective surgery for colorectal cancer should have preoperative imaging of the liver and chest.
- In patients requiring emergency surgery intraoperative liver ultrasound or postoperative imaging is acceptable.
C - Complete colonic examination by colonoscopy, CT pneumocolon or barium enema should be carried out, ideally preoperatively, in patients with colorectal cancer.
Preoperative Preparation
A - 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
Prophylaxis measures should be taken as outlined in the appropriate Scottish Intercollegiate Guideline Network (SIGN) guidelines.
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
B - Mesorectal excision is recommended for most 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 - With a low rectal anastomosis, consider giving a defunctioning stoma.
C - With a low rectal anastomosis after total mesorectal excision (TME), consider a colopouch.
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 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
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.
D - Where facilities and expertise are available, colonic stenting should be considered.
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 Work Load 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 total mesorectal excision.
Pathology
Important Pathological Parameters
B - Pathological reporting of colorectal cancer resection specimens should include information on:
- Tumour differentiation
- Staging (Dukes' and tumour, node, metastasis [TNM] systems)
- Margins (peritoneal and circumferential resection margin [CRM])
- Extramural vascular invasion.
See Annex 1 in the original guideline document for definitions of tumor staging.
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
A - Patients with Dukes' C tumours of the colon or rectum should be considered for adjuvant chemotherapy.
A - Patients with Dukes' B tumours of the colon or rectum should not be treated routinely with adjuvant chemotherapy.
B - Portal vein chemotherapy should not be used as the sole regimen in postoperative adjuvant treatment.
A - The addition of levamisole or interferon alpha to fluorouracil and folinic acid (FUFA) chemotherapy as adjuvant treatment is ineffective in colorectal cancer and should not be considered.
A - The recommended adjuvant regimen in patients with Dukes' C tumours is bolus FUFA, administered over five days every four weeks. The duration of treatment should be six months.
C - The schedule of FUFA given once weekly for 30 weeks used in the QUASAR (QUick And Simple And Reliable) trial may be an acceptable option for certain patients.
Adjuvant Radiotherapy
A - Preoperative radiotherapy, planned with three or four fields, should be considered in patients with operable rectal cancer.
C - When postoperative radiotherapy is indicated, a schedule of 45 Gy in 25 fractions over five weeks is recommended. Patients should not be treated with parallel opposed fields; a planned technique with three or four fields should be used.
C - Chemotherapy should be given synchronously with the radiotherapy using one of the following three regimens:
- Intermittently infused FUFA (Bosset)
- Continuous fluorouracil (Lokich) or
- Bolus FUFA
Chemotherapy for Metastatic Disease
A - All patients with metastatic colorectal cancer should be considered for chemotherapy.
A - Bolus 5-fluorouracil (5-FU) regimens are not recommended as routine first line chemotherapy for advanced disease.
A - Outside a clinical trial, the choice of an appropriate regimen includes continuous infusional fluorouracil (Lokich), FUFA infusion (de Gramont) or capecitabine.
A - Raltitrexed is not recommended as a first line therapy but may be considered as an alternative in those patients intolerant of 5-FU regimens or in whom 5-FU is contraindicated due to cardiotoxicity.
(Although as efficacious as alternative regimens, raltitrexed is associated with significantly greater toxicity and its benefit to patients who are intolerant to 5-FU or with coronary heart disease should be carefully weighted against the potential harms. This recommendation differs from the HTBS comment (Health Technology Board for Scotland comment. [cited 21 Jan 2003]. Available from http://www.htbs.co.uk/htbsadvice/acomment.asp?did=575) on the NICE appraisal [March 2002] which recommends that the use of raltitrexed is restricted to clinical studies.)
C - Initial combination chemotherapy, including oxaliplatin, should be considered in patients fit for hepatic resection but who have inoperable hepatic metastases that might become resectable on treatment.
A - Carefully selected patients with good performance status, normal liver function tests and no evidence of gastrointestinal obstruction with metastatic colorectal cancer, who have progressive disease despite treatment with 5-FU/FA, should be considered for second line treatment with irinotecan.
A - Immune modulation should not be used routinely in the management of advanced colorectal cancer.
Radiotherapy for Advanced Disease
C - Radiotherapy to convert inoperable rectal cancer into operable disease should be combined with chemotherapy. Suitable regimens include intermittent infusional 5-FU/FA (Bosset), continuously infused 5-FU (Lokich) or bolus 5-FU/FA.
D - Palliative radiotherapy should be considered for patients who have distressing pelvic symptoms from rectal cancer.
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
Symptom Management
D - Medical measures such as analgesics, antiemetics and antisecretory drugs should be used alone or in combination to relieve the symptoms of bowel obstruction.
See Scottish Intercollegiate Guideline Network (SIGN) guideline "Control of Pain in Patients with Cancer" for a more detailed discussion of pain assessment and management.
Definitions
Grades of Recommendations
A - At least one meta-analysis, systematic review of randomised controlled trials (RCTs), or randomised controlled trial 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 rate as 2++
D - Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
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
