IRCCS Instituto Clinico Humanitas
Milan, Rozzano, 20089, Italy
Completed
NCT Number: NCT01626196
Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation
Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing.
This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an Italian "real life" setting. In addition, the study is to examine the determinants of quality of bowel cleansing and describe aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma detection rate).
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Written informed consent obtained prior to inclusion.
- Male and female outpatients, aged ≥ 18, treated with bowel cleansing preparation the day before undergoing routine colonoscopy at selected participating centres.
Exclusion criteria
- Children and adolescents aged less than 18 years. Pregnant or breastfeeding women.
- Listed contra-indications to the relevant product used for the bowel cleansing procedure.
- Patients having been submitted to a previous colonoscopy over the last five years.
- Patients who have taken laxative enemas the day preceding the colonoscopy.
Treatment and study plan
No intervention
OtherThis was an observational study
Primary outcomes
-
Patients acceptability of the procedure
Time frame: One day
Secondary outcomes
-
Time to reach the caecum
Time frame: One day
-
Adenoma detection rate
Time frame: One day
Sponsors and collaborators
Lead sponsor
Norgine
Industry
Registry information
Official study title
Multicentre, Observational, Prospective Study, Conducted on Italian Out-patients Undergoing Colonoscopy, for the Evaluation of the Main Determinants of the Patient's Acceptability of Bowel Cleansing Procedure, and of the Success of Bowel Cleansing and Caecal Intubation
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jun 22, 2012
- Registry last updated
- Jul 11, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.