Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02638558
Enrollment
286
Registered
2015-12-23
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2016-09-07

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

Conditions

Colonoscopy Preparation Acceptance

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).

Interventions

OTHERwritten + oral explanation
OTHERwritten explanation

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
patients compliance in taking split-dose preparation in the early morning colonoscopies4 months

Outcome results

None listed

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