Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

Not Applicable

Terminated

• Conditions: Colorectal Cancer
• Interventions: Device: PillCam Colon 2; Procedure: Colonoscopy

• Registration Number: NCT01879943
• Lead Sponsor: IHU Strasbourg

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.

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-18
• Study Start: 2013-10-18
• Primary Completion: 2016-06-08
• Study Completion: 2016-06-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PillCam COLON 2 and Standard Colonoscopy	PillCam Colon 2	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 and Standard Colonoscopy	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

Primary Outcome Measures

Name	Time	Method
Number of patients with full colonic exploration and detection of lesions	By the end of both procedures (Day 1)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Hepato-Gastroenterology, Nouvel Hopital Civil; 🇫🇷 Strasbourg, France