Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

NCT ID: NCT01879943

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-18
• Study Completion Date: 2016-06-08

Brief Summary

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.

Detailed Description

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PillCam COLON 2 and Standard Colonoscopy

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

Group Type: EXPERIMENTAL

PillCam Colon 2

Intervention Type: DEVICE

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

Colonoscopy

Intervention Type: PROCEDURE

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

Interventions

PillCam Colon 2

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

Intervention Type: DEVICE

Colonoscopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHU Strasbourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Delvaux, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Hepato-Gastroenterology, Nouvel Hopital Civil

Strasbourg, , France

Countries

France

Other Identifiers

2012-A01475-38

Identifier Type: OTHER

Identifier Source: secondary_id

12-003

Identifier Type: -

Identifier Source: org_study_id