Usefulness of strengthering the bowel-cleansing preparation in patients with weak previous colonoscopy preparation
Ontology highlight
ABSTRACT:
DISEASE(S): Colonoscopy,Colorectal Cancer,Cáncer Colorectal
PROVIDER: 2539062 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:The gold standard of colorectal examination is colonoscopy. One of the main purposes of colonoscopy is detecting bowel neoplasms. Right now there are several methods the bowel preparation for the colonoscopy.
Several factors can affect the quality of the bowel preparation, such as the kind of oral laxative, the time after its intake and the diet followed in the days before colonoscopy. In this randomized clinical trial the investigators aimed to compare the safety and efficiency of two low-volume laxatives for bowel preparation: potassium, magnesium and sodium sulphates-based laxative Eziclen (IPSEN, France) and Macrogol-3350 + Sodium Sulfate + Potassium Chloride+ Sodium Chloride + Ascorbic Acid-based and Sodium Ascorbate-based Moviprep (Nordgine B.V., The Netherlands)
| 2326744 | ecrin-mdr-crc
Project description:This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at risk of colorectal cancer.
| 2066830 | ecrin-mdr-crc
Project description:Interventions: Clinical, single-blind, randomized, controlled trial. Based on an estimated 30% difference between groups, a sample was calculated in 276 patients, divided into 3 groups (1: 1: 1).
Boston scale was used to assess preparation adequacy, with a score> 2 in each colon follow-up, obtaining an overall maximum score of 9 points.
The intestinal preparation used were:
Bisacodil 10mg the day before the exam and SG5% 1000ml intravenous on the day of the exam was applied to all patients.
Patients were randomized in 3 groups with different preparation solutions, per oral intake:
Group 1: Lactitol 400ml + 300ml of citrus juice,
Group 2: Mannitol20% 500ml + 200ml of citrus juice
Group 3: PEG-macrogol 20 sachets (citrus flavor) + 750ml of water.
After using the solution, in a day hospital scheme, laboratory evaluations and tolerability research were carried out. Experienced endoscopists, blinded to the type of preparation, performed the exam, at least 4 hours after the last dose of the medication. They performed the Boston scale evaluation, as described in the literature, assigning scores to colonic segments. Patients are sedated by anesthesiologists, according to the local protocol of the service.
After anesthetic recovery, patients were discharged from the hospital.
Before and after ingesting the solutions, the serum level of electrolytes (sodium and potassium) was measured; in addition, a scale to assess palatability was applied after completion of preparation. Adverse events were cataloged and classified as mild, moderate or severe.;Drug;A03.556.124.526
Primary outcome(s): It is expected that the lactitol oral solution will be more effective than 20% mannitol and PEG-macrogol solutions for colon cleansing in patients who will undergo a colonoscopy exam.
The suitability will be assessed by the Boston scale score, considering the score greater than 2 points obtained in each intestinal segment to be adequate.
Study Design: Treatment trial, randomized-controlled, uni-blind, with three arms, parallel
| 2559701 | ecrin-mdr-crc
Project description: Not available
| S-EPMC11009472 | biostudies-literature
Project description:Interventions: Whether transadbominal ultrasound can accurately assess bowel preparation quality will be determined with observational comparisons with already scheduled colonoscopies and the Boston Bowel Prep Scale and patient reported bowel preparation quality. Both IBD patients and non IBD patients will be included in this study.
The transabdominal ultrasound will be performed within 30minutes prior to the scheduled colonoscopy (after they have completed their bowel cleansing). The patients at this point are already in a bed and in hospital gowns and being readied for their colonoscopy. With patient privacy in mind and their curtains closed, only their abdomen will be exposed and the rest covered with the bed sheets, towels and their gown as needed. Then ultrasound Jelly is applied to the abdomen and the ultrasound probes (curved and linear) will be used to obtain ultrasound images of the quality of the bowel prep. Then the jelly is simply wiped off and the patient is ready for their colonoscopy.
From previous non-trial ultrasounds for other indications, de-identified images of possible degrees of faeces in the bowel can be used and a numerical scoring system developed (ie from collapsed bowel, to liquid, to semi-solid, to solid/dense material).
Primary outcome(s): To determine if focused transabdominal ultrasound examination of patients prior to their colonoscopy can determine bowel preparation quality (a scoring system designed specifically for this study) as compared to their colonoscopy Boston Bowel Prep score (already validated).
As ultrasound does not have any radiation or risks, no adverse events expected.[Ultrasound examinations will be performed within 30 minutes prior to the colonoscopy.
The Boston Bowel Prep score is part of the standard reporting structure of colonoscopies and will be obtained during the patients colonoscopy by their proceduralist (ie as per standard and without influence from researchers).
];To determine if focused transabdominal ultrasound examination of patients prior to their colonoscopy can determine bowel preparation quality (a scoring system designed specifically for this study) as compared to the patient’s self reported bowel prep scores (survey and self taken bowel motion pictures-a scoring system designed specifically for this study) will be collected/assessed within 60minutes of their colonoscopy. [Ultrasound examinations will be performed within 30 minutes prior to the colonoscopy, and patient’s self reported bowel prep scores (survey and patient taken bowel motion pictures) will be collected/assessed within 60minutes prior to the colonoscopy. Bowel motion pictures will be photos taken by the patient of their last 2 bowel motions using their own phones (within the last 12 hours prior to their colonoscopy) and will be compared to a pre-set chart (to be created- similar to Bristol Stool Chart but for bowel prep).
]
Study Design: Purpose: Screening;Duration: Cross-sectional;Selection: Convenience sample;Timing: Prospective
| 2466911 | ecrin-mdr-crc
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: 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:The aim of this study is to clarify the factors influencing quality of bowel cleansing for colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel cleaning method for patients with colorectal cancer surgery. Through this, ultimately in patients with a history of colorectal cancer who have high risk of colorectal cancer, it could be possible to detect cancerous lesions early and increase the survival rate.
This study is based on observational study Subjects are the patients with colorectal cancer surgery who visits the out patients clinic for follow-up colonoscopy The patient’s medical records on the basis of information collected at the point of the colonoscopy performed Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient compliance and satisfaction are measured.
| 2166677 | ecrin-mdr-crc
Project description:ObjectivesCurrent bowel preparation scales (BPSs) have significant limitations including an inability to distinguish among bowel preparations that adequately cleanse a high percentage of colons. We assessed the reliability and validity of the new Chicago BPS and compared it with existing BPSs.MethodsWe performed a prospective evaluation of the cleanliness of 150 colons. Inter-rater agreement was assessed using kappa and Pearson correlation coefficients. Each colon was rated by a gastroenterologist and physician's assistant using the Ottawa BPS, the Boston BPS, a dichotomous (adequate/inadequate) BPS (where adequate was defined as being able to visualize at least 95% of the mucosa), and the Chicago BPS.ResultsPearson correlation coefficients between the gastroenterologists and physician's assistant for total BPS scores were 0.79 (95% confidence interval (CI): 0.73, 0.85), 0.79 (95% CI: 0.72, 0.84), and 0.84 (95% CI: 0.79, 0.88) for the Ottawa, Boston, and Chicago BPSs, respectively. Kappa coefficients for right, middle, and distal colon segment ratings were 0.66, 0.53, and 0.49, respectively, for the Ottawa BPS; 0.64, 0.66, and 0.54, respectively, for the Boston BPS; and 0.70, 0.62, and 0.63, respectively, for the Chicago BPS. Differences between the Chicago BPS and the other BPSs were not statistically significant. The Chicago BPS exhibited the best correspondence between BPS total score and the adequate/inadequate BPS.ConclusionsThis study demonstrated the validity and reliability of the Chicago BPS. The better defined grading criteria, better designed numerical ratings scale, and better correspondence between Chicago BPS total score and the adequate/inadequate BPS make the Chicago BPS an attractive alternative to the Ottawa BPS and the Boston BPS.
| S-EPMC3865439 | biostudies-literature
Project description:The diagnostic accuracy and safety of colonoscopy highly depends on the quality of the pre-procedural bowel preparation. A past history of poor bowel preparation is the most important risk factor of inadequate bowel cleansing at the next colonoscopy. This study aims to evaluate if an adequate level of bowel cleansing can be achieved with the Pure-Vu System in patients with previous poor bowel preparation, in a single arm international multicenter feasibility study.
| 2363206 | ecrin-mdr-crc