Status:
TERMINATED
Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
Lead Sponsor:
IHU Strasbourg
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
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 scre...
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 anest...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- patient between 18 and 85 years old
- patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology
- patient requiring a colonoscopy for regular medical care
- absence of contra-indication to anesthesia and to colonoscopy conduct
- patient able to understand the study related information and to provide written informed consent
- patient registered with the French social security regime
- Non-inclusion Criteria:
- absence of written informed consent
- patient having had a total colectomy
- patient with terminal stoma
- patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis
- patient with known Zenker diverticulum
- patient wearing a pacemaker or any other internal electronic medical device
- patient with deglutition disorders and/or altered state of consciousness
- patient with serious disease preventing planned study procedures
- pregnant or breast-feeding woman
- patient within exclusion period from other clinical trial
- patient having forfeited their freedom of an administrative or legal obligation
- patient being under guardianship
Exclusion
Key Trial Info
Start Date :
October 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01879943
Start Date
October 18 2013
End Date
June 8 2016
Last Update
April 10 2019
Active Locations (1)
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1
Department of Hepato-Gastroenterology, Nouvel Hopital Civil
Strasbourg, France, 67000