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Comparison of Moviprep and Prepkit C Bowel preparation in inflammatory bowel disease patients and in the general population

ABSTRACT: Interventions: Randomised to two different types of bowel prep: Moviprep or Prep Kit C All patients were provided with the bowel preparation kits and written information explaining appropriate diet changes, instructions on how to prepare and timing of consumption. This information was additionally explained at a face-to-face review in the outpatient clinic up to four weeks before the colonoscopy by either a senior gastroenterologist or a gastroenterology advanced trainee. Arm 1: Moviprep Moviprep comes with two large sachets (sachet A) and two small sachets (sachet B). Each pair of sachets (A and B) is dissolved in one litre of water to make a solution. One litre is taken the evening before the procedure and the other in the early morning on the day of of the colonoscopy. Primary outcome(s): Bowel preparation tolerability as determined by a Tolerability Questionnaire [On day of completion of bowel preparation ] Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Inflammatory And Immune System-other Inflammatory Or Immune System Disorders,Colon Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Inflammatory Bowel Disease

PROVIDER: 2469860 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Consenting patients who are to undergo routine colonoscopy will be randomised to receive the standard bowel preparation or Movicol (intervention) in addition to the standard bowel preparation. Movicol is a combination product available in powder form. Each sachet of Movicol powder contains Macrogol-3350 13.125 g, Sodium chloride 350.7 mg, Sodium bicarbonate 178.5 mg, Potassium chloride 46.6 mg Lemon flavor and Potassium acesulfame as a sweetener. Macrogol 3350 exerts an osmotic action in the gut, which induces a laxative effect. Movicol is routinely used as laxative by increasing stool volume and is indicated in the treatment of chronic constipation. Movicol is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of abdomen and rectum. Each Movicol sachet should be dissolved in 125ml water and taken orally. The usual adult dosage is 1 sachet daily. This may be increased to 2-3 sachets daily as required. Participants in the intervention arm will receive 8 sachets of Movicol to be taken over the 5 days prior to the day of the procedure. The first sachet is to be taken in the evening 5 days prior to the procedure. One sachet is taken at 7am and 7pm for the next 4 days. The eighth sachet is taken on the morning of the day prior to the procedure, ahead of commencing the standard bowel preparation of Prepkit C. An instruction sheet and schedule for taking the Movicol sachets will be provided with the sachets. Participants will be asked to tick a box against each dose taken and return the form on the day of the procedure. This will enable researchers to monitor compliance with the intervention. Primary outcome(s): To determine whether the addition of Movicol prior to a standard bowel preparation improves the quality of bowel preparation in patients undergoing routine colonoscopy procedure. Endoscopists will assess the quality of bowel preparation by use of the Ottawa Bowel Preparation Quality Scale. The scale comprises of 2 parts: Part A of the scale where a score is applied to the degree of cleanliness of each colon segment (i.e. right colon, mid colon and rectosigmoid colon) before washing / suctioning of residual stool. 0 - indicates clearly visible mucosal detail +/- clear fluid with no stool residue 1 - refers to some turbid fluid or stool residue present but visible mucosal detail where washing and suctioning is not necessary 2 - indicates obscured mucosal detail by turbid fluid or stool residue where suctioning but not washing is necessary 3 - refers to stool obscuring mucosal detail where suctioning and washing is necessary to obtain a reasonable view 4 - indicates solid stool obscuring mucosal details despite aggressive washing and suctioning Part B of the scale is the measure of fluid in the colon where 0 indicates small amount, 1 moderate amount and 2 large amount Successful bowel preparation is defined by: A score of 2 or lesser in each colonic segment in part A and a score of 2 or lesser for fluid in part B of the scale [Day of colonoscopy procedure] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

Project description:Interventions: Whether transadbominal ultrasound can accurately assess bowel preparation quality will be determined with observational comparisons with already scheduled colonoscopies and the Boston Bowel Prep Scale and patient reported bowel preparation quality. Both IBD patients and non IBD patients will be included in this study. The transabdominal ultrasound will be performed within 30minutes prior to the scheduled colonoscopy (after they have completed their bowel cleansing). The patients at this point are already in a bed and in hospital gowns and being readied for their colonoscopy. With patient privacy in mind and their curtains closed, only their abdomen will be exposed and the rest covered with the bed sheets, towels and their gown as needed. Then ultrasound Jelly is applied to the abdomen and the ultrasound probes (curved and linear) will be used to obtain ultrasound images of the quality of the bowel prep. Then the jelly is simply wiped off and the patient is ready for their colonoscopy. From previous non-trial ultrasounds for other indications, de-identified images of possible degrees of faeces in the bowel can be used and a numerical scoring system developed (ie from collapsed bowel, to liquid, to semi-solid, to solid/dense material). Primary outcome(s): To determine if focused transabdominal ultrasound examination of patients prior to their colonoscopy can determine bowel preparation quality (a scoring system designed specifically for this study) as compared to their colonoscopy Boston Bowel Prep score (already validated). As ultrasound does not have any radiation or risks, no adverse events expected.[Ultrasound examinations will be performed within 30 minutes prior to the colonoscopy. The Boston Bowel Prep score is part of the standard reporting structure of colonoscopies and will be obtained during the patients colonoscopy by their proceduralist (ie as per standard and without influence from researchers). ];To determine if focused transabdominal ultrasound examination of patients prior to their colonoscopy can determine bowel preparation quality (a scoring system designed specifically for this study) as compared to the patient’s self reported bowel prep scores (survey and self taken bowel motion pictures-a scoring system designed specifically for this study) will be collected/assessed within 60minutes of their colonoscopy. [Ultrasound examinations will be performed within 30 minutes prior to the colonoscopy, and patient’s self reported bowel prep scores (survey and patient taken bowel motion pictures) will be collected/assessed within 60minutes prior to the colonoscopy. Bowel motion pictures will be photos taken by the patient of their last 2 bowel motions using their own phones (within the last 12 hours prior to their colonoscopy) and will be compared to a pre-set chart (to be created- similar to Bristol Stool Chart but for bowel prep). ] Study Design: Purpose: Screening;Duration: Cross-sectional;Selection: Convenience sample;Timing: Prospective

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

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Comparison of Moviprep and Prepkit C Bowel preparation in inflammatory bowel disease patients and in the general population

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