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

Valduce Hospital

Status: Completed

Conditions: Colonoscopy Preparation Acceptance

Treatments: Other: written + oral explanation; Other: written explanation

Study type: Interventional

Funder types: Other

Identifiers

NCT02638558

04/2015

Details and patient eligibility

About

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).

Enrollment: 286 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• every patient who needs a colonoscopy

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

written + oral explanation

Experimental group

Description:

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

Treatment:

Other: written + oral explanation

written explanation

Experimental group

Description:

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

Treatment:

Other: written explanation