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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: 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. CONDITION: Gastrointestinal PRIMARY OUTCOME: 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 ; SECONDARY OUTCOME: To assess polyp detection rates between the control and intervention groups. The number of polyps detected during the endoscopic insertion and withdrawal is recorded on the colonoscopy report as per standard care. For the purpose of this study, this data will be recorded on an endoscopist datasheet which has been designed by the researchers specifically for the study. The quality of bowel preparation will also be assessed by use of the validated Ottawa Bowel Preparation Quality Scale and recorded on the endoscopist datasheet at this time. This data will enable the researchers to determine whether quality of bowel preparation has an effect on polyp detection rate. To assess successful completion of colonoscopy between the control and intervention groups. Completion of colonoscopy is assessed by whether the caecum can be viewed by identification of the appendiceal orifice and triradiate fold. A photo is taken of this view as evidence of completion and as per standard practice.. To assess time taken to complete the procedure between the control and intervention groups. This is assessed by recording the time interval from the start of the procedure by insertion of the endoscope to the removal of the endoscope from the anus. The duration of the procedure is recorded as part of standard care, importantly withdrawal time is calculated once insertion is completed after reaching the caecum. To examine patient compliance with a Movicol‐augmented bowel preparation prior to colonoscopy. Compliance will be assessed by asking participants in the intervention group to record on the Movicol instruction and schedule sheet when each sachet dose is taken (by ticking boxes). The Movicol instruction/schedule sheet has been designed by the researchers specifically for the study. To examine patient tolerance and acceptance with a Movicol‐augmented bowel preparation compared with a standard bowel preparation prior to colonoscopy. A study questionnaire which has been designed by the researchers specifically for the study will ask participants to answer questions about their experience taking the bowel preparation they were allocated to.. INCLUSION CRITERIA: Consenting adult patients referred for outpatient colonoscopy procedure for clinically accepted indications (these generally include but are not restricted to iron deficiency anaemia, surveillance of bowel polyps, colorectal cancer screening, assessment of symptoms such as abdominal pain, diarrhoea and constipation, assessment or investigation of inflammatory bowel disease)
Epistemonikos ID: c7dad68a25cececdc719dbb5dbeea7080b0c1f44
First added on: Aug 24, 2024