Evaluation of the Impact of Direct Conversation With Patients in the Compliance With the "Split-dose" Regimen Preparation for Colonoscopy Scheduled in the First Part of the Morning

Not Applicable

Completed

• Conditions: Colonoscopy Preparation Acceptance
• Interventions: Other: written explanation; Other: written + oral explanation

• Registration Number: NCT02638558
• Lead Sponsor: Valduce Hospital

Brief Summary

Split-dose cleansing regimens for colonoscopies, independently from the type of laxative used, are now recommended over full (one day)-dose regimens from all the major guidelines. It is wellknown that splitting the dose (half of the dose the night before and half the day of the colonoscopy) is safe and guarantees a better cleansing of the colon and thus a higher chance of identifying mucosal lesions. This is crucial both in terms of achieving a high-quality colonoscopy and in terms of time and money saved.

Still, there are some issues about compliance and tolerability with split-dose regimens. Two recent prospective works have shown that only a small number of patients (33%) chooses the split-dose regimen when the colonoscopy is scheduled before 10 a.m. and when patients are forced to used the split-dose, 1/7 did not comply with it, especially if the procedure is before 10 a.m. The most common concerns are about early wake-up, travel interruption and fear of incontinence. Both these papers state that strategies to reduce this noncompliance are needed.

The investigators aim to prove whether an "active action" (an oral explanation before the colonoscopy about why split-dose regimens are better) may improve patients' compliance in endoscopies scheduled in the early morning (from 8 to 10 a.m).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-30
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-23
• Study Start: 2016-01
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Last Update Submitted: 2016-09-04
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• every patient who needs a colonoscopy

Exclusion Criteria

• incapacity in reading and/or in oral comprehension
• contraindications in drinking the preparation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
written explanation	written explanation	patients will receive only a written explanation for preparation with split dose
written + oral explanation	written + oral explanation	patients will undergo both written and oral explanation for preparation with split dose

Primary Outcome Measures

Name	Time	Method
patients compliance in taking split-dose preparation in the early morning colonoscopies	4 months