We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01626196
First Posted: June 22, 2012
Last Update Posted: July 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norgine
June 20, 2012
June 22, 2012
July 11, 2012
February 2012
June 2012   (Final data collection date for primary outcome measure)
Patients acceptability of the procedure [ Time Frame: One day ]
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 ]
  • Adenoma detection rate [ Time Frame: One day ]
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01626196
NIT MOV 1002
No
Not Provided
Not Provided
Norgine
Norgine
Not Provided
Principal Investigator: Alessandro Repici, MD Instituto Clinico Humanitas
Norgine
July 2012