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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02638558
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
Alida Andrealli, 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).

Condition or disease Intervention/treatment Phase
Colonoscopy Preparation Acceptance Other: written + oral explanation Other: written explanation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: written + oral explanation
patients will undergo both written and oral explanation for preparation with split dose
Other: written + oral explanation
Experimental: written explanation
patients will receive only a written explanation for preparation with split dose
Other: written explanation

Primary Outcome Measures :
  1. patients compliance in taking split-dose preparation in the early morning colonoscopies [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • every patient who needs a colonoscopy

Exclusion Criteria:

  • incapacity in reading and/or in oral comprehension
  • contraindications in drinking the preparation
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Responsible Party: Alida Andrealli, MD, Valduce Hospital Identifier: NCT02638558    
Other Study ID Numbers: 04/2015
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: December 2015