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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01626196
Enrollment
600
Registered
2012-06-22
Start date
2012-02-29
Completion date
2012-06-30
Last updated
2012-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Routine Colonoscopy

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).

Interventions

OTHERNo intervention

This was an observational study

Sponsors

Norgine
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Patients acceptability of the procedureOne day

Secondary

MeasureTime frame
Time to reach the caecumOne day
Adenoma detection rateOne day

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026