1. to compare the detection rate of colorectal polyps and cancer by CCE versus conventional colonoscopy in a surveillance population. 2. to investigate patients* acceptance, perceived burden and preference for surveillance test.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure:
The colorectal polyp miss-rate of CCE.
Secondary outcome
Secondary outcome measures:
1. Factors influencing the colorectal polyp miss-rate of CCE (bowel cleanliness
and characteristics of missed polyps).
2. Acceptance and burden of CCE
3. Patient preference regarding CCE or CC for surveillance.
Background summary
Colorectal cancer (CRC) is one of the most common cancers in western countries.
Appropriate screening and surveillance could not only reduce the morbidity and
mortality of CRC but also its incidence. Conventional colonoscopy (CC) is
considered to be the best available method for the detection of adenomas and
CRC. However, this is an invasive and costly procedure, associated with a
procedural risk. The ideal test for screening and surveillance purposes should
be safe, less invasive and cheaper than CC, and with a high diagnostic
accuracy. Following the success of the small bowel capsule endoscopy, colon
capsule endoscopy (CCE) might be an attractive alternative for colon screening
and surveillance.
Study objective
1. to compare the detection rate of colorectal polyps and cancer by CCE versus
conventional colonoscopy in a surveillance
population.
2. to investigate patients* acceptance, perceived burden and preference for
surveillance test.
Study design
Patients with a personal or family history of colorectal polyps or cancer
scheduled for a surveillance colonoscopy will first undergo CCE, followed by a
CC, within approximately one week. In both methods all detected polyps will be
classified with respect to segmental location, size, morphology and macroscopic
aspect. The conventional colonoscopy will be performed with segmental
unblinding for the results of the CCE. Conventional colonoscopy in combination
with histology will be used as reference standard. The determination of
true-positive polyps for CCE will be done by an independent physician,
experienced in capsule endoscopy, comparing the documented characteristics,
pictures and (if needed) videos of all detected polyps during both CCE and CC.
Study burden and risks
A risk of videocapsule endoscopy is retention of the capsule. In patients
without (suspected) intestinal stenosis or obstruction this risk is negligible.
To date no adverse events were reported with CCE.
For Voor colon capsule endoscopie is net als bij de conventionele colonoscopie
darmvoorbereiding noodzakelijk met laxeermiddelen en een aangepast dieet.
Patienten die meedoen aan dit onderzoek zullen dit twee keer moeten ondergaan,
zowel voor de colon capsule endoscopie als voor de conventionele colonoscopie.
meibergdreef 9
1105 AZ Amsterdam
Nederland
meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients with a personal history of colorectal adenomas or CRC or a family history for CRC, scheduled for surveillance colonoscopy at the endoscopy department of the Academic Medical Center or the Slotervaart Hospital.
Exclusion criteria
Age younger than 18 years
Personal history of IBD
Polyposis syndromes
Known colorectal polyps, not removed at prior endoscopy
Dysphagia
Known or suspected intestinal obstruction
Surgical intestinal anastomosis
Inability to understand patient information and/ or give informed consent
Renal insufficiency
Congestive heart failure
Pacemaker or implantable cardiac defibrillator
No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24178.018.08 |