Specific Verbal vs. Usual Instructions for Inpatients Undergoing Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Providing Specific Verbal Instructions Improves Bowel Preparation of Inpatients Undergoing Colonoscopy: a Multi-center Single Blinded Randomized Study

Conditions
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Adequate Colonoscopy Preparation for Inpatients

Intervention / Treatment
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* Procedure: SPECIFIC VERBAL INSTRUCTIONS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Participants getting SPECIFIC VERBAL INSTRUCTIONS before starting bowel preparation (Group A). | Procedure: SPECIFIC VERBAL INSTRUCTIONS<br>* Participants will be randomized either to get detailed instructions verbally by the medico-paramedical staff of the participating centers (physicians or nurses) before starting bowel preparation (Group A) or to get ordinary instructions as usual in each of the participating centers (Group B). Instructions provided to Group A will include details about the procedure of bowel preparation, its potential side effects and the importance of the adequate preparation (Appendix)<br>|
| No Intervention: Group B<br>Participants getting ordinary instructions as usual in each of the participating centers (Group B). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in the number of examinations with adequate bowel preparation | Bowel preparation will be considered adequate if overall BBPS≥6 and all segments achieving BBPS≥2. | At colonoscopy completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall BBPS score change |  | At colonoscopy completion | 
| Segmental BBPS score changes |  | At colonoscopy completion | 
| Total examination time, cecal intubation time and time needed to washout during the colonoscopy |  | At colonoscopy completion | 
| Cecal intubation rate |  | At cecum intubation | 
| Percentage of patients who received the whole amount of liquid preparation |  | Before colonoscopy start | 
| Polyp and adenoma detection rate (overall and per segment) |  | Up to 4 weeks after patient's enrollment | 
| Side effects related either to the preparation or the examination | A questionnaire will be used as assessment method | Before colonoscopy start | 
| Identification of potential additional risk factors for inadequate preparation | Identification of potential additional risk factors for inadequate preparation (e.g. a bed status, performance status, autonomy level (measured by the Katz score) ΑSA Score, diabetes, use of tricyclic antidepressants, history of inadequate bowel preparation, chronic constipation, history of abdominal surgery other than colectomy, use of opioids, proposed predictive score. A questionnaire will be used. | After colonoscopy completion | 
| Patient satisfaction from the bowel preparation using the visual analogue scale. |  | After colonoscopy completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel preparation, colonoscopy, inpatients, cathartics