Clinical trial NCT01879943: Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
Official title: Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Follow up
Colonoscopy
Videocapsule
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with full colonic exploration and detection of lesions
timeFrame: By the end of both procedures (Day 1)
Secondary outcomes:
measure: Anastomosis visualization
timeFrame: Prior to colonoscopy on Day 1
measure: Number and size of detected lesions
timeFrame: By the end of both procedures (Day 1)
measure: Quality of colic preparation
timeFrame: By the end of both procedures (Day 1)
measure: Times related to videocapsule
timeFrame: Prior to colonoscopy on Day 1
measure: Adverse events related to VCC exam and colonoscopy
timeFrame: Until end of Day 1
measure: Patient's assessment of tolerability and acceptance
timeFrame: Follow up visit (between Day 15 and Day 30)
measure: Health-economic assessment
timeFrame: End of follow-up (between D15 and D30)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Department of Hepato-Gastroenterology, Nouvel Hopital Civil
Study officials:
affiliation: Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France
name: Michel Delvaux, MD
role: PRINCIPAL_INVESTIGATOR
References: