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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
  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:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Norgine:

Primary Outcome Measures:
  • Patients acceptability of the procedure [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT01626196     History of Changes
Other Study ID Numbers: NIT MOV 1002
Study First Received: June 20, 2012
Last Updated: July 10, 2012
Health Authority: Italy: Ministry of Health

ClinicalTrials.gov processed this record on June 17, 2013