Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Number of patients with full colonic exploration and detection of lesions
Number of patients for whom the capsule allowed for full colonic exploration and presence/absence of colorectal lesions detected by VCC compared to conventional colonoscopy
By the end of both procedures (Day 1)
Michel Delvaux, MD
Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France
France: Agence Nationale de Sécurité du Médicament et des produits de santé