Clinical trial NCT02887014: Specific Verbal vs. Usual Instructions for Inpatients Undergoing Colonoscopy
Official title: Providing Specific Verbal Instructions Improves Bowel Preparation of Inpatients Undergoing Colonoscopy: a Multi-center Single Blinded Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adequate Colonoscopy Preparation for Inpatients
Keywords: bowel preparation
colonoscopy
inpatients
cathartics
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Ioannina
name: University Hospital of Patras
name: Larissa University Hospital
First posted: 2016-09-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.

Detailed description: Introduction Adequate bowel preparation constitutes one of the most important endoscopy quality indicators: it is related with increased detection of pathologic findings, reduces the need for repeated colonoscopies and leads to burden lightening for both patients and endoscopy departments. Different factors have been related to inadequate preparation. Among them, inpatient status has been identified as a major independent risk factor.

It has been shown that providing outpatients with simple, but specific instructions regarding the importance and mode of adequate preparation - either through a leaflet, a sms or on the web - improves significantly the level of bowel cleanliness. However, data regarding the success of such an intervention in inpatients lack.

Aim To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.

Patients - Methods Study Design This is a prospective, randomized, single-blinded study. Four Greek academic endoscopy departments will competitively enroll patients during a period of 6 months.

Randomization A central randomization list will be computer-assisted, created and sent to one collaborator of each center. Endoscopists will be blinded to participant's group.

300 patients will be randomized in 2 groups, in blocks of 10 with an analogy 1:1. They will also be stratified in a 60%-40% percentage depending on whether the patient is bedridden or not at the time of the examination

Statistical Analysis According to the literature similar interventions showed a gain of 20% in favor of the intervention. Statistical significance level α is defined 5% and the study is powered at the level of 80%. According to data from Hepatogastroenterology Unit of Attikon University General Hospital regarding the adequateness of bowel preparation of patients undergoing colonoscopy and with an expected 10% drop out, 300 patients are needed (including a 10% drop out) in order to succeed 18% improvement of the primary endpoint (from 66% for inpatients during 2015 to 84% for outpatients during the same period) favoring the intervention group. Interim analysis and sample size re-estimation will be undergone after data collection from 90 patients.

Both an intention to treat (ITT) and a per protocol (PP) analysis are planned. Data will be recorded in predefined CRFs.

Eligibility criteria: Inclusion Criteria:

* assignment of informed consent

Exclusion Criteria:

* inability to provide informed consent
* history of colectomy
* indication for rectosigmoidoscopy
* lack of knowledge of the Greek language.

Primary outcomes:
measure: Increase in the number of examinations with adequate bowel preparation
timeFrame: At colonoscopy completion
Secondary outcomes:
measure: Overall BBPS score change
timeFrame: At colonoscopy completion
measure: Segmental BBPS score changes
timeFrame: At colonoscopy completion
measure: Total examination time, cecal intubation time and time needed to washout during the colonoscopy
timeFrame: At colonoscopy completion
measure: Cecal intubation rate
timeFrame: At cecum intubation
measure: Percentage of patients who received the whole amount of liquid preparation
timeFrame: Before colonoscopy start
measure: Polyp and adenoma detection rate (overall and per segment)
timeFrame: Up to 4 weeks after patient's enrollment
measure: Side effects related either to the preparation or the examination
timeFrame: Before colonoscopy start
measure: Identification of potential additional risk factors for inadequate preparation
timeFrame: After colonoscopy completion
measure: Patient satisfaction from the bowel preparation using the visual analogue scale.
timeFrame: After colonoscopy completion
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital
Study officials:
affiliation: Attikon Hospital
name: Konstantinos Triantafyllou, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lee YJ, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Education for Ward Nurses Influences the Quality of Inpatient's Bowel Preparation for Colonoscopy. Medicine (Baltimore). 2015 Aug;94(34):e1423. doi: 10.1097/MD.0000000000001423.
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citation: Srisarajivakul N, Chua D, Williams R, Leigh L, Ou A, Quarta G, Poles MA, Goodman A. How We Cleaned It Up: A Simple Method That Improved Our Practice's Bowel Prep. Am J Gastroenterol. 2016 Aug;111(8):1079-81. doi: 10.1038/ajg.2016.148. Epub 2016 Apr 26. No abstract available.
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