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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:
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
  Purpose

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 Intervention
Routine Colonoscopy Other: No intervention

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Norgine:

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

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

Enrollment: 600
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Colonoscopy patients
Patients undergoing with bowel cleansing procedures according to the clinics' usual routine
Other: No intervention
This was an observational study

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

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


Locations
Italy
IRCCS Instituto Clinico Humanitas
Milan, Rozzano, Italy, 20089
Sponsors and Collaborators
Norgine
Investigators
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 Submitted: June 20, 2012
First Posted: June 22, 2012
Last Update Posted: July 11, 2012
Last Verified: July 2012