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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

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ClinicalTrials.gov Identifier: NCT01626196
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

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).

Condition or disease Intervention/treatment
Routine Colonoscopy Other: No intervention

Study Design

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official 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
Study Start Date : February 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Colonoscopy patients
Patients undergoing with bowel cleansing procedures according to the clinics' usual routine
Other: No intervention
This was an observational study

Outcome Measures

Primary Outcome Measures :
  1. Patients acceptability of the procedure [ Time Frame: One day ]

Secondary Outcome Measures :
  1. Time to reach the caecum [ Time Frame: One day ]
  2. Adenoma detection rate [ Time Frame: One day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients invited for routine colonoscopy were invited to participate in hte study.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626196

IRCCS Instituto Clinico Humanitas
Milan, Rozzano, Italy, 20089
Sponsors and Collaborators
Principal Investigator: Alessandro Repici, MD Instituto Clinico Humanitas
More Information

Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT01626196     History of Changes
Other Study ID Numbers: NIT MOV 1002
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012