The impact of wearing an abdominal corset to achieve compression on colonoscopy outcomes: a randomised controlled trial

2021 ◽  
Vol 19 (Sup2) ◽  
pp. S18-S23
Author(s):  
Zeynep Kızılcık Özkan ◽  
Ümmü Yıldız Fındık ◽  
Doğan Albayrak
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
University Hospital ◽  
Intubation Time ◽  
Abdominal Compression ◽  
Position Change ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

Aim: This study aimed to evaluate the effect of abdominal corset use on colonoscopy outcomes in patients undergoing colonoscopy. Methods: This randomised controlled trial was conducted between March 2019 and January 2020, with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital. Half (n=30) of these patients were included in the experimental group and wore an abdominal corset during colonoscopy. Findings: It was determined that there was no statistically significant difference between the groups according to variables, including caecal intubation time (p=0.371), the need for position change in the colonoscopy process (p=0.554), position change in caecum imaging (p=1.000) and manual abdominal compression during the procedure (p=0.091). Conclusions: The results of this study reveal that abdominal corset usage does not provide a significant extra benefit compared with conventional colonoscopy in improving colonoscopy outcomes.

scholarly journals Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

scholarly journals Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024256 ◽  
Author(s):  
Elizabeth G Ryan ◽  
Ewen M Harrison ◽  
Rupert M Pearse ◽  
Simon Gates
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gastrointestinal Surgery ◽  
Evidence Based ◽  
Bayesian Analyses ◽  
Therapy Algorithm ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact

ObjectiveThe traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.Design, setting, participants and interventionsThe OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.MethodsWe repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.ResultsAlthough OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.ConclusionsThe use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.Trial registration numberISRCTN04386758; Post-results.

Efficacy of Heroin-Assisted Treatment in Belgium: A Randomised Controlled Trial

2015 ◽  
Vol 21 (4) ◽  
pp. 179-187 ◽  
Author(s):  
Isabelle Demaret ◽  
Etienne Quertemont ◽  
Géraldine Litran ◽  
Cécile Magoga ◽  
Clémence Deblire ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Methadone Treatment ◽  
Control Group ◽  
Heroin Addicts ◽  
Heroin Use ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Experimental Group

Background/Aims: Heroin-assisted treatment (HAT) can improve the condition of heroin addicts still using street heroin after a methadone treatment. In Belgium, a new trial compared the efficacy of a HAT to existing methadone maintenance treatment. Methods: In this randomised controlled trial, HAT was limited to 12 months. Participants were assessed every 3 months. They were responders if they showed improvement on the level of street heroin use, health or criminal involvement. Results: 74 participants were randomised in the trial. The experimental group (n = 36) counted 30% of responders more than the control group (n = 38) at each assessment point (p < 0.05), except at 12 months where the difference (11%) was no longer significant (p = 0.35). Still, after 12 months, participants in the experimental group reported significantly greater improvements (p < 0.05) than the control group on the level of street heroin use and on the level of physical and mental health. Both groups reported significantly less criminal acts after 12 months (p < 0.001), but with no significant difference between the groups. Conclusions: This trial confirms the short-term efficacy of HAT for severe heroin addicts, who already failed methadone treatment.

scholarly journals Rationale and protocol for the efficacy, safety and tolerability of nangibotide in patients with septic shock (ASTONISH) phase IIb randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e042921
Author(s):  
Bruno Francois ◽  
Simon Lambden ◽  
Sebastien Gibot ◽  
Marc Derive ◽  
Aurelie Olivier ◽  
...  
Keyword(s):  
Septic Shock ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Lactate Concentration ◽  
Blood Lactate Concentration ◽  
Ethics Committee ◽  
University Hospital ◽  
Institutional Review Boards ◽  
Randomised Controlled ◽  
The Impact

IntroductionSeptic shock is the subgroup of patients with sepsis, which presents as vasopressor dependence, an elevated blood lactate concentration and is associated with a mortality of at least 30%. Expression of the triggering receptor expressed on myeloid cells 1 (TREM-1) pathway, measured using a serum biomarker of pathway activation (soluble TREM-1, sTREM-1) has been associated with outcome in septic shock. Preclinical and early phase patient data suggest that therapeutic modulation of this pathway may improve survival.Methods and analysisEfficacy, Safety and Tolerability of Nangibotide in Patients with Septic Shock is a phase IIb randomised controlled trial that will take place in up to 50 centres in seven countries and recruit 450 patients with septic shock to receive either placebo or one of two doses of nangibotide, a novel regulator of the TREM-1 pathway. The primary outcome will be the impact of nangibotide therapy on the change in Sequential Organ Failure Assessment score from a baseline determined before initiation of study drug therapy. This will be assessed first in the patients with an elevated sTREM-1 level and then in the study population as a whole. In addition to safety, secondary outcomes of the study will include efficacy of nangibotide in relation to sTREM-1 levels in terms of organ function, mortality and long-term morbidity. This study will also facilitate the development of a novel platform for the measurement of sTREM-1 at the point of care.Ethics and disseminationThe study has been approved by the responsible ethics committees/institutional review boards in all study countries: Belgium: Universitair Ziekenhuis Antwerpen, France: CPP Ile de France II, Denmark: Region Hovedstaden, Spain: ethics committee from Valld’Hebron Hospital, Barcelona, Finland: Tukija, Ireland: St. James’ Hospital (SJH) / Tallaght University Hospital (TUH) Joint Research Ethics Committee, USA: Lifespan, ProvidenceTrial registration numbersEudraCT Number: 2018-004827-36 and NCT04055909.

scholarly journals Examining the impact of oral hygiene advice and/or scale and polish on periodontal disease: the IQuaD cluster factorial randomised controlled trial

BDJ ◽  
2021 ◽  
Vol 230 (4) ◽  
pp. 229-235
Author(s):  
Jan Clarkson ◽  
Craig Ramsay ◽  
Thomas Lamont ◽  
Beatriz Goulao ◽  
Helen Worthington ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Periodontal Disease ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
The Impact

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1042
Author(s):  
Nicholas Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

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