This trial is active, not recruiting.

Condition colorectal cancer
Treatments pillcam colon 2, colonoscopy
Sponsor IHU Strasbourg
Start date October 2013
End date October 2016
Trial size 100 participants
Trial identifier NCT01879943, 12-003, 2012-A01475-38


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose diagnostic
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
PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps.
Standard colonoscopy is the standard against which capsule endoscopy is compared.

Primary Outcomes

Number of patients with full colonic exploration and detection of lesions
time frame: By the end of both procedures (Day 1)

Secondary Outcomes

Anastomosis visualization
time frame: Prior to colonoscopy on Day 1
Number and size of detected lesions
time frame: By the end of both procedures (Day 1)
Quality of colic preparation
time frame: By the end of both procedures (Day 1)
Times related to videocapsule
time frame: Prior to colonoscopy on Day 1
Adverse events related to VCC exam and colonoscopy
time frame: Until end of Day 1
Patient's assessment of tolerability and acceptance
time frame: Follow up visit (between Day 15 and Day 30)
Health-economic assessment
time frame: End of follow-up (between D15 and D30)

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
Principal investigator Michel Delvaux, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by IHU Strasbourg.