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Cola

Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day.

Interventions:

* Device: PillCam COLON 2 on D0
* Procedure: Standard colonoscopy on D1

PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps.

PillCam Colon 2

Standard colonoscopy is the standard against which capsule endoscopy is compared.

Colonoscopy

Michel Delvaux, MD

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.

Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

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

Anastomosis visualization by VCC and type (latero-lateral, termino-lateral, latero-terminal and termino-terminal)

Number and size of detected lesions with VCC compared to conventional colonoscopy

Assessment of the quality of colic preparation for VCC (D0) and colonoscopy (D1)

Assessment of times related to videocapsule:

* Transit time of videocapsule : from ingestion to expulsion
* Reading time : time required for reading and analysing videocapsule recordings by gastroenterologist

Assessment of safety of each method. Recording of adverse events.

Patient ranking of tolerability and acceptance of each of the procedures using a visual analog scale

Assessment of costs associated to each of the exams:

* Colonoscopy duration (OR entry - exit)
* Device cost (coloscope, capsule)
* Cost of medical exams related to each procedure (from pre-anesthesia to follow-up)
* Cost of medical time related to each procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery	NCT01879943	Colorectal Canc...	PillCam Colon 2 Colonoscopy	18 Years - 85 Years	IHU Strasbourg
Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery	NCT01879943	Colorectal Canc...	PillCam Colon 2 Colonoscopy	18 Years - 85 Years	IHU Strasbourg

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