Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

Colorectal Cancer Clinical Trial

Official title:

Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01879943
• Other study ID #: 12-003
• Secondary ID: 2012-A01475-38
• Status: Terminated
• Phase: N/A
• Start date: October 18, 2013
• Est. completion date: June 8, 2016

Study information

• Verified date: April 2019
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: June 8, 2016
• Est. primary completion date: June 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Department of Hepato-Gastroenterology, Nouvel Hopital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anastomosis visualization	Anastomosis visualization by VCC and type (latero-lateral, termino-lateral, latero-terminal and termino-terminal)	Prior to colonoscopy on Day 1
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Adverse events related to VCC exam and colonoscopy	Assessment of safety of each method. Recording of adverse events.	Until end of Day 1
Secondary	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)
Secondary	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)