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A study about the effect of a telephone call on the quality of Bowel Preparation

ABSTRACT: Interventions: The intervention of this study consists on a telephone call for patients with a scheduled colonoscopy at Clínica Gastrocenter - Institute of Surgery and Gastroenterology of Belo Horizonte. The telephone call will be made two nights before the colonoscopy and consists on remembering the instructions for bowel preparation (already informed during the consult at the clinic) and clarifying possible doubts. The duration of the call will be approximately 2 minutes. - Experimental group: 164 participants (men or women over 18 years old) who will receive a phone call 2 nights before the colonoscopy, lasting 2 minutes and that will recall the instructions for bowel preparation. - Control group: 164 patients (men or women over 18 years) who will not receive a phone call 2 nights before the colonoscopy. But, like the experimental group, they will receive instructions during the consult at the clinic.;14067 Primary outcome(s): It is expected to find an improvement in the quality of bowel preparation of patients who receive a phone call the day before colonoscopy, verified by the Boston Bowel Preparation Scale, with a variation of at least 5% between the scores of the intervention and control groups.

DISEASE(S): Intestinal Polyposis,Colorectal Neoplasia

PROVIDER: 2561133 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Participants in the interventional arm of the study will receive their bowel preparation instructions delivered via scheduled SMS, web-based smartphone application, email, and videos. All enrolled participants must possess a smartphone device. The interventional arm will occur in parallel design with the control arm. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the faecal occult blood test (FOBT) nurse or the gastroenterologist at the initial phone call, participants will be stratified into one of two groups depending on their indicated bowel preparation regimens. Participants will be either given Standard Bowel Preparation instructions with PLENVU [macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride, potassium chloride; polyethylene glycol containing ascorbic acid (PEG-ASC)], or Enhanced Bowel Preparation [PLENVU plus daily Movicol (sodium chloride, potassium chloride, bicarbonate, macrogol 3350) and Senokot (sennoside)]. Additional aperients, such as Movicol and Senokot, will be encouraged in the interventional arm through dynamic multimedia instructions if indicated. Participants will be asked to take PLENVU over a two-day split dosing schedule with the first 500 mL dose of PLENVU (including additional 500 mL of clear fluid) taken in the evening before the clinical procedure (at 6 pm) and the second 500 mL dose (including additional 500 mL of clear fluid) in the early morning of the day of the clinical procedure (at 5 am for morning procedure or 8 am for afternoon procedures). Participants in the Enhanced Bowel Preparation group will also take 1 sachet of Movicol and 2 Senokot tablets daily at 0800 in the week leading up to the colonoscopy. In t Primary outcome(s): Comparison of the adenoma detection rate based on histopathology assessment of biopsy samples collected at the time of colonoscopy in patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive verbal and/or written bowel preparation instructions.[At the time of colonoscopy assessment.];Compare the patient reported measures using the validated colonoscopy-specific Newcastle ENDOPREM Questionnaire on the day after colonoscopy between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.[One day after colonoscopy assessment.] Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Dataset Information

A study about the effect of a telephone call on the quality of Bowel Preparation

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