Dissections OBSERVATIONAL

6 April 2009
Evidence-based Medicine for Surgeons

Flexible sigmoidoscopy and whole colonic imaging in the diagnosis of cancer in patients with
colorectal symptoms

Authors: Thompson MR, Flashman KG, Wooldrage K et al

Journal: British Journal of Surgery 2008; 95:1140-1146
Centre: Department of colorectal surgery, Queen Alexandra Hospital, Portsmouth, UK
Flexible sigmoidoscopy permits visualization of the distal 60 cm of the colon, with minimal bowel
preparation, as an outpatient procedure. Uncertainty of the probability of a residual proximal
BACKGROUND cancer often leads to the performance of other whole colonic imaging (WCI) procedures. There
are no clear guidelines on this decision and WCI are offered in an arbitrary, inefficient fashion.
Authors' claim(s): “Patients with iron deficiency anemia [IDA] or a mass
RESEARCH QUESTION require whole colon imaging [WCI]. However, in patients with [other]
symptoms alone, FS [flexible sigmoidoscopy] detects 95% of cancers, and the
Population
diagnostic yield of WCI after FS is very low.”
Patients referred to a specialist
colorectal clinic in the UK for
evaluation of colorectal symptoms,
IN SUMMARY
during a 16 year period (1986- The argument in summary - cancers detected from 16,433 screenings
2001). Distal Proximal
Indicator variable (<60 cm from anal verge) (> 60 cm from anal verge)

Flexible sigmoidoscopy for Based on presentation

evaluation of symptoms in all IDA or mass (604) 65 (10.8%) 94 (15.6%)
patients referred to the unit.
Other symptoms (15,829) 750 (4.7%) 37 (0.2%)
Outcome variable
Based on diagnostic test
Detection of colorectal cancer.
Flexible sigmoidoscopy only 786 -
Comparison Subsequent whole colon 17 116
Other whole colonic imaging (WCI) imaging (WCI) - (5665)
studies (colonoscopy, barium Missed with FS only 5 5
enema, rigid sigmoidoscopy).
Missed after WCI 5 9

THE BOTTOM LINE

The paper lends support to a protocol that many of us intuitively use in deciding whether to stop with a flexible
sigmoidoscopy or proceed with colonoscopy in patients presenting with symptoms and signs suggestive of a colonic
neoplasm. The numbers are large and the data is well analyzed. The only effective method of trapping the "missed"
segment on flexible sigmoidoscopy would be a policy of universal whole colon imaging: clearly a wasteful strategy based
on the very small yield that is shown in the study. An ideal study would involve a prospective trial of FS followed by
blinded WCI on all comers. In the absence of such data, using a clinical algorithm that splits patients into two groups as
suggested by the authors and using FS as the screening tool in all those who present without IDA or an abdominal mass,
appears to be an effective, resource-sensitive strategy.

EBM-O-METER
Evidence level Bias level Bias levels
Double blind RCT Sampling
Randomized controlled trial (RCT) Comparison
Trash Swiss Safe News-
Prospective cohort study - not randomized cheese worthy Measurement
Life's too Holds water
short for this Full of holes “Just do it”
Case controlled study
Interestingl | Novel l | Feasible l
Case series - retrospective  Ethical l | Resource saving l

The devil is in the details (more on the paper) ... 

© Dr Arjun Rajagopalan
 SAMPLING
Sample type Inclusion criteria Exclusion criteria Final score card
Simple random All patients referred to Already diagnosed Study
a colorectal clinic for before referral 
Stratified random Target -
evaluation of Anorectal disease on
Cluster symptoms and signs rectal exam  Accessible 17271
suggestive of colorectal
Consecutive cancer, between 1986 Intended 16433
Convenience and 2001  Drop outs 0
Judgmental Study 16433

 = Reasonable | ? = Arguable |  = Questionable

Sampling bias: The study was done in a special interest, referral centre dealing with large volumes, in a single
hospital in the United Kingdom and therefore, may not be applicable to other centres with lesser skills and other
countries with different prevalence rates of colorectal cancer. The numbers, however, are large. Recruitment into
the study appears excellent. Drop out rates are minimal.

COMPARISON
Randomized Case-control Non-random Historical None

Controls - details
Allocation details Patients were stratified at presentation into two groups: those presenting with an abdominal
mass and/or iron deficiency anemia and those presenting only with symptoms (rectal
bleeding, change in bowel habits or abdominal pain).

Flexible sigmoidoscopy was performed on all patients with either no bowel preparation or a a
self-administered phosphate enema. Patients were submitted to whole colon imaging (barium
enema, colonoscopy or CT colonography) on a subjective, arbitrary basis. Clinical history, and
findings on investigations were recorded in a pro forma.
Comparability -
Disparity -

Comparison bias: An ideal study would involve each patient serving as his or her own control. This would involve
performing FS first and then submitting the patient to a WCI performed or read by another investigator who was not
aware of the results of FS. Only then can the critical question - how many cancers were missed - be answered with
certainty. In this study, only 5665 of the cohort of 16433 patients received both FS and WCI. We are left with the
assumption that the 10000 plus remaining patients were only available for assessment as "missed" cancers,
assuming that they were all available for long term follow up, the details of which are sketchy in this paper.

MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.

Device suited to task

Training

Scoring

Blinding
Repetition

Protocols

Y ? N

"Missed" cancer: not detected at initial ?

examination after FS or referral for WCI but
diagnosed within 3 years by:
a. referral back to the unit.
b. local audit of all cancers treated in the area.
c. direct comparison with the regional Cancer
Registry which had a 95% ascertainment for bowel
cancer.

Measurement bias: No specific data is offered on the completeness of this all important element.

© Dr Arjun Rajagopalan