Assessing the quality of bowel preparation by addition of Movicol to standard bowel preparation regimen in patients undergoing routine colonoscopy: a randomized controlled trial

ABSTRACT: 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

DISEASE(S): Cancer-bowel-anal,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Gastrointestinal

PROVIDER: 2463758 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR