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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: PillCam Colon 2; Procedure: Colonoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Department of Hepato-Gastroenterology, Nouvel Hopital Civil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.; Procedure: Colonoscopy; Standard colonoscopy is the standard against which capsule endoscopy is compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomosis visualization	Anastomosis visualization by VCC and type (latero-lateral, termino-lateral, latero-terminal and termino-terminal)	Prior to colonoscopy on Day 1
Number and size of detected lesions	Number and size of detected lesions with VCC compared to conventional colonoscopy	By the end of both procedures (Day 1)
Quality of colic preparation	Assessment of the quality of colic preparation for VCC (D0) and colonoscopy (D1)	By the end of both procedures (Day 1)
Times related to videocapsule	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	Prior to colonoscopy on Day 1
Adverse events related to VCC exam and colonoscopy	Assessment of safety of each method. Recording of adverse events.	Until end of Day 1
Patient's assessment of tolerability and acceptance	Patient ranking of tolerability and acceptance of each of the procedures using a visual analog scale	Follow up visit (between Day 15 and Day 30)
Health-economic assessment	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	End of follow-up (between D15 and D30)

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Investigators: Principal Investigator: Michel Delvaux, MD, Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2013
• Primary Completion (Actual): June 8, 2016
• Study Completion (Actual): June 8, 2016

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 18, 2013

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colonoscopy; Follow up; Videocapsule
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 12-003; 2012-A01475-38 (Other Identifier: ANSM France)