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

NCT ID: NCT02638558

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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).

Conditions

Colonoscopy Preparation Acceptance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

written + oral explanation

patients will undergo both written and oral explanation for preparation with split dose

Group Type: EXPERIMENTAL

written + oral explanation

Intervention Type: OTHER

written explanation

patients will receive only a written explanation for preparation with split dose

Group Type: EXPERIMENTAL

written explanation

Intervention Type: OTHER

Interventions

written + oral explanation

Intervention Type: OTHER

written explanation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• every patient who needs a colonoscopy

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valduce Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alida Andrealli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

04/2015

Identifier Type: -

Identifier Source: org_study_id