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Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

18 Years
85 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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

Inclusion Criteria:

1. patient between 18 and 85 years old

2. patient with greater than 3 month follow-up for colorectal resection with ileo-colic
, colo-colic or colorectal anastomosis, regardless of etiology

3. patient requiring a colonoscopy for regular medical care

4. absence of contra-indication to anesthesia and to colonoscopy conduct

5. patient able to understand the study related information and to provide written
informed consent

6. patient registered with the French social security regime

Non-inclusion Criteria:

1. absence of written informed consent

2. patient having had a total colectomy

3. patient with terminal stoma

4. patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis

5. patient with known Zenker diverticulum

6. patient wearing a pacemaker or any other internal electronic medical device

7. patient with deglutition disorders and/or altered state of consciousness

8. patient with serious disease preventing planned study procedures

9. pregnant or breast-feeding woman

10. patient within exclusion period from other clinical trial

11. patient having forfeited their freedom of an administrative or legal obligation

12. patient being under guardianship

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Number of patients with full colonic exploration and detection of lesions

Outcome Description:

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

Outcome Time Frame:

By the end of both procedures (Day 1)

Safety Issue:


Principal Investigator

Michel Delvaux, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

June 2013

Completion Date:

June 2015

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Follow up
  • Colonoscopy
  • Videocapsule
  • Colorectal Neoplasms