Colorectal Cancer Clinical Trial
Official title:
Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard
colonoscopy in patients with prior colorectal surgery.
The hypothesis is to validate the VCC as a means of screening for colonic polyps after
resection, which would avoid a colonoscopy with its associated general anesthesia and
potential side effects.
Standard care after colorectal surgery is colon surveillance by standard colonoscopy with its
benefits (gold standard examination, resection of lesions) and disadvantages (acceptability,
general anesthesia, availability of qualified personnel, risk of perforation and associated
gastrointestinal bleeding).
Use of a video-capsule (VCC) is a new, non-invasive technique, that allows to visualize the
colon as a whole. This technique has the advantage of not requiring general anesthesia or air
insufflation. The examination is performed as an outpatient procedure and therefore does not
require hospitalization.
In previous studies, PillCam COLON 2 showed a good sensitivity and specificity in detecting
colorectal lesions. However, its use requires an excellent bowel preparation.
To date, no study has been conducted using the VCC in monitoring patients with prior
colorectal surgery, especially on the passage of the VCC through surgical anastomosis. No
information on VCC capabilities to view and recognize surgical anastomoses and VCC transit
time in surgically modified colon is available. The possibility to precisely locate a
colorectal lesion prior to surgery, using the VCC, also remains to be studied.
The study requires a 2-month patient participation. The planned total study duration is 2
years.
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