The Use of Osmotic Laxatives Versus Macrogol for Bowel Preparation in Patients Undergoing Colonoscopy
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Disorders,Colorectal Cancer
PROVIDER: 2326744 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
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.
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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
| 2733492 | ecrin-mdr-crc
Project description:Interventions: IMPACT Advanced Recovery is a beverage made by Nestle which contains special nutrients (immunonutrients) which may enhance the immune system in patients having major surgery, improving patient recovery. In our treatment group, patients undergoing surgery for colorectal (bowel) cancer will be given a pamphlet containing information on healthy eating for surgery, as well as IMPACT Advanced Recovery drinks to consume before the operation. These participants will be instructed to take 3 x 237 mL drink packs a day, for 5 consecutive days before their operation, with the last drink to be taken two days before their operation.
The ingredients in IMPACT Advanced Recovery (Vanilla) are: Water, Sugar, Calcium caseinate (milk), Sodium caseinate, L-arginine, Refined fish oil (anchovy, sardine) and less than 2% of corn oil, Citric acid, Medium chain triglycerides, Maltodextrin, Natural and artificial flavor, Yeast extract, Potassium citrate, Potassium chloride, Calcium phosphate, Magnesium phosphate, Salt, Magnesium chloride, Cellulose gel, Cellulose gum, Choline chloride, Sodium ascorbate, Sucralose (sweetener), Carrageenan, Zinc sulfate, Ferrous sulfate, D-alpha-tocopherol, Niacinamide, Soybean oil, Dl-alpha tocopheryl acetate, Calcium pantothenate, Copper gluconate, Manganese sulfate, Vitamin A palmitate, Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, Beta-carotene, Folic acid, Potassium iodide, Sodium selenite, Sodium molybdate, Chromium chloride, Vitamin K1, Biotin, Vitamin D3, Vitamin B12.
The pamphlet for the treatment group provides the same information as the control pamphlet, as well as information on what IMPACT Advanced Recovery is, its ingredients and reported benefits, and how to take it before one’s operation. These pamphlets have been ma
Primary outcome(s): Number of infectious complications will be calculated by reviewing medical records, and classified using the Centers for Disease Control and Prevention classification: superficial incisional, deep incisional or organ/space infection.[30 days post-operatively]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy
| 2464662 | ecrin-mdr-crc
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
| 2463758 | ecrin-mdr-crc
Project description:Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could be suitable substitution of polyethylene glycol.
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Project description:Adequate bowel cleansing is important for a completeness of colonoscopy and detection of colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and obscured mucosal visualization resulting in missed lesions.
Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium picosulphate with magnesium citrate (SPMC).
There are rare reports that compare directly conventional polyethylene glycol (PEG) solution and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.
The aim of this study is to compare the efficacy, safety, and tolerability of different regimens of SPMC and PEG solution.
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