FFI and PR Could Improve Bowel Cleansing.

Study Overview
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Brief Summary
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background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens. Methods:This was an endoscopist-blind,randomized controlled trial. 320inpatients were randomized 1:1 in one of the two study groups. The intervention group received face-to-face instruction and personalized intervention for bowel preparation protocol, while control group received the standard bowel preparation protocol. Patients'demographics, bowel preparation quality, colonoscopy completion and attendance were recorded. Logistic regression was performed to identify predictors of bowel preparation failure.

Official Title
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Face-to-face Instructions and Personalized Bowel Cleansing Regimens for Inpatients Could Improve Bowel Preparation Quality.

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: PEG-FFI
* Drug: PEG-nonFFI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients undergoing colonoscopy. patients older than 18 years. Exclusion Criteria: prior surgery of colorectal resection; suspected colonic stricture or perforation; incomplete or complete bowel obstruction; use of prokinetic agents or purgatives within 7 days; Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;; pregnancy or lactation; Inability to prepare bowel; unable to give informed consent.

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: PEG-FFI prep<br>On the day before colonoscopy, an experienced researcher would go to the ward to have a face-to-face conversation with the patient to know if patients have the risk factors for bowel preparation failure. The bowel preparation regimens for patients with risk factors would be optimized. In addition to drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min, the patient also drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at 20:00- 21:00 hours on the day before the colonoscopy. Patients without risk factors drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Patients would received a booklet to explain the details of diet restriction, preparation method and the pictures of bowel preparation of results.The researcher would give a detailed oral explanation of the booklet. | Drug: PEG-FFI<br>* Patients with risk factor : on the day before the colonoscopy at 20:00- 21:00 hours, 60gPEG-4000 was mixed with 1L water; 4-6 h before colonoscopy, 120gPEG-4000 was mixed with 2L water. Patient without risk factor: 4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water. Education completed by experienced researcher.<br>|
| Active Comparator: PEG-nonFFI prep<br>Patients in the PEG-nonFFI group would only receive routine patient education on bowel preparation of colonoscopy, which was completed by ward nurse. all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. | Drug: PEG-nonFFI<br>* All patients on the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water. Education completed by ward nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Bowel Preparation | The BBPS is a validated scoring system with scores between 0 and 9, where 9 is the best score. The score comprises a sub score 0-3 for each colon segment: right, transverse and left colon. For all participants, BBPS score will be used when colonscopy is withdrawing. | 1 Day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Including nausea, vomiting, abdominal pain and bloating,etc. | The day of colonoscopy and the day before | 
| cecal intubation rate | The number of colonoscopy reaching the cecal area divided by the total number of colonoscopy | 1 Day of colonoscopy | 
| polyp detection rate | PDR was defined as the number of patients with at least one polyp divided by the total number of colonoscopy patients | 1 Day of colonoscopy | 
| cecal intubation time | Time to reach the cecal | 1 Day of colonoscopy | 
| withdrawal time | Time from withdrawal from the cecum to the end of colonoscopy | 1 Day of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel preparation; face-to-face instruction; personalized intervention