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Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norgine
ClinicalTrials.gov Identifier:
NCT01626196
First received: June 20, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes

June 20, 2012
July 10, 2012
February 2012
June 2012   (final data collection date for primary outcome measure)
Patients acceptability of the procedure [ Time Frame: One day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01626196 on ClinicalTrials.gov Archive Site
  • Time to reach the caecum [ Time Frame: One day ] [ Designated as safety issue: No ]
  • Adenoma detection rate [ Time Frame: One day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation
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

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).
Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Consecutive patients invited for routine colonoscopy were invited to participate in hte study.
Routine Colonoscopy
Other: No intervention
This was an observational study
Colonoscopy patients
Patients undergoing with bowel cleansing procedures according to the clinics' usual routine
Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01626196
NIT MOV 1002
No
Norgine
Norgine
Not Provided
Principal Investigator: Alessandro Repici, MD Instituto Clinico Humanitas
Norgine
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP