Dataset Information

Effect of ambient temperature on quality of bowel preparation for colonoscopy

ABSTRACT: Interventions: This trial is a secondary analysis of existing data collected as part of a previous prospective trial investigating the efficacy and tolerability of different bowel preparations in both inflammatory bowel disease patients and the general population. In the original trial, patients were randomised to two different types of bowel preparation (Moviprep or Prep Kit C). We added ambient temperature as the minimum and maximum temperature documented by the local Bureau of Meteorology weather observation station on the day prior to the scheduled colonoscopy. No additional participant involvement was required. Primary outcome(s): Quality of bowel preparation as determined using the validated Ottawa Bowel Preparation Score. This grades the quality of bowel preparation from 0 to 4 (with 0 being no fluid and 4 pertaining to fluid/faecal material unable to be cleared) in three colonic segments (right, left and rectosigmoid) to reach a total score out of 14. All endoscopists attended calibrating sessions prior to study commencement. Two endoscopists assessed the efficacy of bowel cleansing regime independently at the time of the procedure. An average score was then calculated. Inadequate bowel preparation is defined as an Ottawa Bowel Preparation Score equal to or greater than 8.[At time of colonoscopy. ]

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Oral And Gastrointestinal-inflammatory Bowel Disease,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Inflammatory Bowel Disease,Colorectal Polyps

PROVIDER: 2470704 | 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: 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

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Effect of ambient temperature on quality of bowel preparation for colonoscopy

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