Dataset Information

The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol for randomized controlled trial.

ABSTRACT: Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. A new device called Endocuff Vision™ has been shown to improve adenoma detection rate in pilot studies.This is a prospective, multicenter, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy with standard colonoscopy. All patients above 18 years of age referred for screening, surveillance, or diagnostic colonoscopy who are able to consent are invited to the study. Patients with absolute contraindications to colonoscopy, large bowel obstruction or pseudo-obstruction, colon cancer or polyposis syndromes, colonic strictures, severe diverticular segments, active colitis, anticoagulant therapy, or pregnancy are excluded. Patients are randomized according to site, age, sex, and bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or standard colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Nurse assessment of patient comfort and patient comfort questionnaires are completed post procedure. Patients are followed up at 21 days and complete a patient experience questionnaire. This study will take place across seven NHS Hospital Trusts: one in London and six within the Northern Region Endoscopy Group. A maximum of 10 colonoscopists per site will recruit a total of 1772 patients, with a maximum of four bowel screening colonoscopists permitted per site.This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ in all screening, surveillance, and diagnostic patient groups. This timely study will guide clinicians as to the role of Endocuff Vision™ in routine colonoscopy.ISRCTN11821044.

SUBMITTER: Bevan R

PROVIDER: S-EPMC4751019 | biostudies-other | 2016 Feb

REPOSITORIES: biostudies-other

ACCESS DATA

Similar Datasets

Project description:Optic neuritis is a frequent manifestation of multiple sclerosis. Visual deficits range from a minor impairment of visual functions through to complete loss of vision. Although many patients recover almost completely, roughly 35% of patients remain visually impaired for years, and therapeutic options for those patients hardly exist. Vision restoration therapy is a software-based visual training program that has been shown to improve visual deficits after pre- and postchiasmatic injury. The aim of this pilot study is to evaluate whether residual visual deficits after past or recent optic neuritis can be reduced by means of vision restoration therapy.A randomized, controlled, patient- and observer-blinded clinical pilot study (VISION study) was designed to evaluate the efficacy of vision restoration therapy in optic neuritis patients. Eighty patients with a residual visual deficit after optic neuritis (visual acuity ?0.7 and/or scotoma) will be stratified according to the time of optic neuritis onset (manifestation more than 12 months ago (40 patients, fixed deficit) versus manifestation 2 to 6 months ago (40 patients, recent optic neuritis)), and randomized into vision restoration therapy arm or saccadic training arm (control intervention). Patients will be instructed to complete a computer-based visual training for approximately 30 minutes each day for a period of 6 months. Patients and evaluators remain blinded to the treatment allocation throughout the study. All endpoints will be analyzed and P-values < 0.05 will be considered statistically significant. The primary outcome parameter will be the expansion of the visual field after 3 and 6 months of treatment as determined by static visual field perimetry and high resolution perimetry. Secondary outcome variables will include visual acuity at both low and high contrast, glare contrast sensitivity, visually evoked potentials, optical coherence tomography and other functional tests of the visual system, alertness, health-related quality of life, fatigue, and depression.If vision restoration therapy is shown to improve visual function after optic neuritis, this method might be a first therapeutic option for patients with incomplete recovery from optic neuritis.NCT01274702.

Project description:BACKGROUND:Diabetes mellitus is rapidly becoming one of the leading causes of morbidity and mortality worldwide. Preventive measures have become important, especially in the South Asian region and other parts of the world where diabetes is becoming increasingly prevalent. We postulate that a product containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects on glycemic control and disease progression in patients with pre-diabetes and we aim to evaluate this hypothesis using a phase II/III randomized double-blind controlled clinical trial design. METHODS/DESIGN:The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 6?months. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo, Sri Lanka. A total of 110 adults with pre-diabetes will be recruited for the study. They will be randomly assigned to the test and placebo groups on a 1:1 ratio. The test group will receive two tablets of Lysulin™ three times a day and the control group will receive identical placebo tablets. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1?month (visit 1), 3?months (visit 2) and 6?months (visit 4). The primary outcome will be defined as change in glycemic control measured by HbA1c from baseline. Data will be analyzed using SPSS v16. DISCUSSION:To our knowledge this is one of the first randomized controlled trials evaluating the effects of Lysulin™ (a combination of lysine, vitamin C and zinc) in pre-diabetes. This study will provide the necessary groundwork for future large-scale multicentered clinical trials. The result, positive or negative, should provide a step change in the evidence guiding current and future policies regarding management of pre-diabetes. TRIAL REGISTRATION:Sri Lanka Clinical Trials Registry, SLCTR/2018/022 . Registered on 13 July 2018. Study protocol version 2.0 (23 March 2018).

Project description:BACKGROUND:In pre-hospital emergency care, video laryngoscopes (VLs) with disposable blades are preferably used due to hygienic reasons. However, there is limited existing data on the use of VLs with disposable blades by emergency medical staff. Therefore, the aim of this study was to compare the efficacy of four different VLs with disposable blades and the conventional standard Macintosh laryngoscope, when used by anesthetists with extensive previous experience and paramedics with little previous experience in endotracheal intubation (ETI) in a simulated difficult airway. METHODS:Fifty-eight anesthetists and fifty-four paramedics participated in our randomized crossover manikin trial. Each performed ETI with the new Glidescope® Go™, the Dahlhausen VL, the King Vision™, the I-View™ and the Macintosh laryngoscope. "Time to intubate" was the primary endpoint. Secondary endpoints were "time to vocal cords", "time to ventilate", overall success rate, number of intubation attempts and optimization maneuvers, Cormack-Lehane score, severity of dental compression and subjective impressions. RESULTS:The Glidescope® Go™, the Dahlhausen VL and the King Vision™ provided superior intubation conditions in both groups without affecting the number of intubation attempts or the time required for successful intubation. When used by anesthetists with extensive experience in ETI, the use of VLs did not affect the overall success rate. In the hands of paramedics with little previous experience in ETI, the failure rate with the Macintosh laryngoscope (14.8%) decreased to 3.7% using the Glidescope® Go™ and the Dahlhausen VL. Despite the advantages of hyperangulated video laryngoscopes, the I-View™ performed worst. CONCLUSIONS:VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI. Our results therefore suggest that hyperangulated VLs could be beneficial and might be the method of choice in comparable settings, especially for emergency medical staff with less experience in ETI.

Dataset Information

The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol for randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets