Adequate Colonoscopy Preparation for Inpatients
Conditions
Keywords
bowel preparation, colonoscopy, inpatients, cathartics
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.
Interventions
PROCEDURESPECIFIC VERBAL INSTRUCTIONS
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)
Sponsors
University Hospital, Ioannina
University Hospital of Patras
Larissa University Hospital
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in the number of examinations with adequate bowel preparation | At colonoscopy completion | Bowel preparation will be considered adequate if overall BBPS≥6 and all segments achieving BBPS≥2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Overall BBPS score change | At colonoscopy completion | — |
| Side effects related either to the preparation or the examination | Before colonoscopy start | A questionnaire will be used as assessment method |
| Identification of potential additional risk factors for inadequate preparation | After colonoscopy completion | 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. |
| Patient satisfaction from the bowel preparation using the visual analogue scale. | After colonoscopy completion | — |
| Polyp and adenoma detection rate (overall and per segment) | Up to 4 weeks after patient's enrollment | — |
Countries
Greece
Contacts
Primary ContactKonstantinos Triantafyllou, Ass. Prof.
Outcome results
None listed