Trial record 14 of 254 for:    Open Studies | colonoscopy

Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by IHU Strasbourg
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg
ClinicalTrials.gov Identifier:
NCT01879943
First received: June 14, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer
Device: PillCam Colon 2
Procedure: Colonoscopy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by IHU Strasbourg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
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)
Arms Assigned Interventions
Experimental: PillCam COLON 2 and Standard 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
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.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879943

Contacts
Contact: Michel Delvaux, MD + 33 3 69 55 03 13 michel.delvaux@chru-strasbourg.fr

Locations
France
Department of Hepato-Gastroenterology, Nouvel Hopital Civil Recruiting
Strasbourg, France, 67000
Principal Investigator: Michel Delvaux, MD         
Sponsors and Collaborators
IHU Strasbourg
Investigators
Principal Investigator: Michel Delvaux, MD Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France
  More Information

No publications provided

Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT01879943     History of Changes
Other Study ID Numbers: 12-003, 2012-A01475-38
Study First Received: June 14, 2013
Last Updated: June 24, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by IHU Strasbourg:
Colorectal cancer
Follow up
Colonoscopy
Videocapsule

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014