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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery|
- Number of patients with full colonic exploration and detection of lesions [ Time Frame: By the end of both procedures (Day 1) ] [ Designated as safety issue: No ]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
- Anastomosis visualization [ Time Frame: Prior to colonoscopy on Day 1 ] [ Designated as safety issue: No ]Anastomosis visualization by VCC and type (latero-lateral, termino-lateral, latero-terminal and termino-terminal)
- Number and size of detected lesions [ Time Frame: By the end of both procedures (Day 1) ] [ Designated as safety issue: No ]Number and size of detected lesions with VCC compared to conventional colonoscopy
- Quality of colic preparation [ Time Frame: By the end of both procedures (Day 1) ] [ Designated as safety issue: No ]Assessment of the quality of colic preparation for VCC (D0) and colonoscopy (D1)
- Times related to videocapsule [ Time Frame: Prior to colonoscopy on Day 1 ] [ Designated as safety issue: No ]
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
- Adverse events related to VCC exam and colonoscopy [ Time Frame: Until end of Day 1 ] [ Designated as safety issue: Yes ]Assessment of safety of each method. Recording of adverse events.
- Patient's assessment of tolerability and acceptance [ Time Frame: Follow up visit (between Day 15 and Day 30) ] [ Designated as safety issue: No ]Patient ranking of tolerability and acceptance of each of the procedures using a visual analog scale
- Health-economic assessment [ Time Frame: End of follow-up (between D15 and D30) ] [ Designated as safety issue: No ]
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
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: PillCam COLON 2 and Standard Colonoscopy
Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879943
|Contact: Michel Delvaux, MD||+ 33 3 69 55 03 firstname.lastname@example.org|
|Department of Hepato-Gastroenterology, Nouvel Hopital Civil||Recruiting|
|Strasbourg, France, 67000|
|Principal Investigator: Michel Delvaux, MD|
|Principal Investigator:||Michel Delvaux, MD||Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France|