To investigate what CTC iodine tagging-only bowel preparation gives a high image quality and readability of the CTC together with a high patient acceptance.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are the homogeneity and density of the residual
faeces, the amount of residual fluid and the quality of tagging in CTC*s and
the patient acceptance in three patient groups that received different iodine
tagging preparations.
Secondary outcome
Secondary endpoint is evaluation of the polyp detection in the three patient
groups that received a different bowel preparation.
Background summary
For computed tomography colonography (CTC) bowel preparation different
cathartic and/or tagging agents are used. Because the bowel preparation is
often rated the most burdensome aspect of the examination by patients, it is
important to minimize this. Tagging-only bowel preparations have a minimal
catharsis, but it is also necessary that image quality remains sufficient for
evaluation of the CTC.
Study objective
To investigate what CTC iodine tagging-only bowel preparation gives a high
image quality and readability of the CTC together with a high patient
acceptance.
Study design
This is a prospective cohort study. The study population consists of FOBT
positive patients that are allocated to 3 patient groups that receive different
bowel preparations and a low-fiber diet: In group 1 are patients that receive
3*50 ml iodine contrast agent; group 2 receives 4*25 ml iodine contrast; and
group 3 receives 3*25 ml iodine contrast. After ingestion of the contrast
agents patients receive a CTC and after 1 week a colonoscopy (which is standard
procedure for all FOBT positives).
Study burden and risks
Risks for the subjects undergoing the CTC examination are minimal. CTC is a
diagnostic procedure so there are no direct therapeutic effects. Diagnostic
positive effects for the subject exist when polyps or carcinoma*s are found at
the CTC that are not found primarily at optical colonoscopy. Treatment for
polyps and/or carcinoma can follow after diagnosis which can lengthen the
survival of the subject. Minimal risks on bowel perforation exist because an
automatic CO2 insufflator is used to inflate the colon. Because a reduced
radiation dose protocol is used, a reasonably low risk on radiation induced
cancer exists. Furthermore no serious adverse events due to iodine oral
contrast are expected. A group-related benefit of this diagnostic study is that
due to a minimal bowel preparation for CTC, the burden of the CTC bowel
preparation might be further diminished.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
All patients who are tested positive in the framework of the ZONMW granted FOBT pilot study, who are willing to undergo colonoscopy and who want to give informed consent.
Exclusion criteria
Patients who had examinations for research purposes with radiation exposure in the last 12 months, iodine contrast allergy, hyperthyroidism and pregnancy.
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 | NL23716.018.08 |