Dataset Information

PLENVU vs Prepkit-C Bowel Preparation for Colonoscopy

ABSTRACT: Interventions: PLENVU is a novel, low volume (1L) polyethylene glycol based bowel preparation that has demonstrated a good safety profile and an overall bowel cleansing success in two European and one American phase 3 trials,. Consenting patients who are to undergo routine colonoscopy will be randomised to receive PLENVU or the standard bowel preparation at Alfred Hospital using Prepkit-C. Participants will be provided instruction sheets for taking the preparation to which they are allocated. To assess acceptance and tolerance, participants will be asked to complete a questionnaire on the day of and ahead of the procedure. Primary outcome(s): Bowel cleanliness will be assessed using the Boston Bowel Preparation Scale as follows: Each of the 3 segments of the colon (right, including the cecum and ascending colon; transverse, including the hepatic and splenic flexures; and left, including the descending colon, sigmoid, and rectum) will be given a score from 0 to 3 defined as: 0 - unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared 1 - portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid 2 - minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well 3 - entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid Each of the 3 segment scores is then summed for a total score of 0 to 9, in which 0 is unprepared and 9 is entirely clean. If an endoscopist aborts a procedure because of inadequate preparation, then any non-visualized proximal segments are assigned a score of 0. Successful bowel preparation requires a minimum BBPS of 6 with a score of 2 or more in each bowel segment. [Day of colonoscopy procedure] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Cancer-bowel-anal,Bowel Preparation For Colonoscopy,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2466942 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:The aim of the study is to determine if Serrated Poliposis Syndrome (SPS) patients with SPS criteria 2, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at last colonoscopy have the same advanced neoplasia incidence in the surveillance colonoscopy at 2 or 3 years. Patients selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years. Randomization will be done at the database program (RedCAP). All colonoscopies will be performed with high definition (HD) system and it will be the choice of the endoscopist whether to use chromoendoscopy with indigo carmine o virtual chromoendoscopy. Protocol bowel preparation will be recommended by each centre. Sedation will be prescribed and decided by the endoscopist during the examination. Data from all the resected and visualized lesions during the colonoscopy will be collected on the database. A pathologist familiarized with serrated lesions will be in charge of the sample analysis. Serrated lesions will be classified attending de WHO criteria for serrated lesions. The investigators define "advanced adenoma" as adenomas ≥10 mm with villous histology and/or with high grade of dysplasia (HGD). The investigators define "advanced SL" as any SL ≥10mm and any SL with dysplasia. The investigators also define "advanced neoplasia" as any colorectal cancer (CRC), any advanced adenoma or advanced Serrated Lesions (SL). Quality of bowel cleansing will be graded by each endoscopist following the Boston Bowel Preparation Scale. This scale evaluates each segment (ascending colon, transverse colon and descending colon) of the following form: 0 = segment of colon whose mucosa cannot be seen due to the existence of solid stools that cannot be eliminated; 1 = mucosa portion of a colonic segment that can be seen, but other areas of the colonic segment are not seen, either due to the presence of dirt, feces or opaque liquid; 2 = existence of small amount of dirt, small fragments of stool and / or opaque liquid, but the mucosa of the colonic segment can be seen well; 3 = all the mucosa of the colonic segment can be seen well without residual dirt, small traces of stool or opaque liquid. Patients with inadequate preparation (when in any segment the score is 0 or 1, or the total score is less than 6) will be excluded from the study. During colonoscopy all complications as post-polypectomy bleeding, perforation or cardio-respiratory events will be registered. Those complications will be considered if surgery or hospital admission is required.

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:Background: The molecular basis of segment specific epithelial functions of the stomach and bowel has not been established. Regionally unique molecular properties of epithelial cells can be identified using cell-specific gene expression in each epithelial region by comparative mRNA analysis. Aim: To describe segment-specific epithelial mRNA content by comparative mRNA analysis of purified epithelial cell suspensions of stomach, small and large bowel. Results: 12% of all annotated genes show segment specific enrichment. The gastric (>3000 genes) and ileal (519 genes) mucosa show the most diverse expression profile. (a) Stomach: The gastric mucosa expresses the machinery for acid secretion, digestive enzyme release, and hormone release by gastric enteroendocrine cells. Associated with acid secretion is a specific set of K+, Cl-, and bicarbonate channels. Novel is a pathway for glucose and fatty acid sensing, iodine and glutamate uptake, and taurine synthesis. Specific sets of transcription factors control epithelial (Barx1, Runx) and enteroendocrine (FoxA2/N4) cell differentiation. (b) Small Bowel: This epithelium expresses genes coding for a unique fructose/glucose uptake and utilization mechanism. Enteroendocrine signalling to the gastric function is present. The upper portion expresses genes for iron uptake, bicarbonate secretion, and detoxification of food contents. Epithelial differentiation is transcriptionally controlled by Meis2/Pdx1 and Onecut 2. Expression of digestive enzymes, lipid/bile acid uptake and utilization increases distally. The ileal epithelium is also involved in innate and acquired immune defence, regulation of motility, and electrolyte and water re-absorption. Transcriptional regulation of enterocyte and goblet cell differentiation is mainly controlled by increasing expression of Cdx1 and 2. (c) Colon: This epithelium is mainly involved in Ca++-, K+, and water re-absorption, fatty acid uptake and sensing, and innate and acquired immune defence. Epithelial differentiation is controlled by Hox transcription factors in addition to Cdx1/2. Conclusion: This regional survey of gene expression by the GI tract epithelium reveals unique epithelial properties, raising several important questions as to the role of the proteins encoded in gut physiology.

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PLENVU vs Prepkit-C Bowel Preparation for Colonoscopy

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