Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial

Background and aimsColonoscopy is the current reference standard for the detection of colorectal neoplasia, but nevertheless adenomas remain undetected. The Endocuff, an endoscopic cap with plastic projections, may improve colonic visualisation and adenoma detection. The aim of this study was to compare the mean number of adenomas per patient (MAP) and the adenoma detection rate (ADR) between Endocuff-assisted colonoscopy (EAC) and conventional colonoscopy (CC).MethodsWe performed a multicentre, randomised controlled trial in five hospitals and included fecal immonochemical test (FIT)-positive screening participants as well as symptomatic patients (>45 years). Consenting patients were randomised 1:1 to EAC or CC. All colonoscopies were performed by experienced colonoscopists (≥500 colonoscopies) who were trained in EAC. All colonoscopy quality indicators were prospectively recorded.FindingsOf the 1063 included patients (52% male, median age 65 years), 530 were allocated to EAC and 533 to CC. More adenomas were detected with EAC, 722 vs 621, but the gain in MAP was not significant: on average 1.36 per patient in the EAC group versus 1.17 in the CC group (p=0.08). In a per-protocol analysis, the gain was 1.44 vs 1.19 (p=0.02), respectively. In the EAC group, 275 patients (52%) had one or more adenomas detected versus 278 in the CC group (52%; p=0.92). For advanced adenomas these numbers were 109 (21%) vs 117 (22%). The adjusted caecal intubation rate was lower with EAC (94% vs 99%; p<0.001), however when allowing crossover from EAC to CC, they were similar in both groups (98% vs 99%; p value=0.25).InterpretationThough more adenomas are detected with EAC, the routine use of Endocuff does not translate in a higher number of patients with one or more adenomas detected. Whether increased detection ultimately results in a lower rate of interval carcinomas is not yet known.Trial registration numberhttp://www.trialregister.nlDutch Trial Register: NTR3962.

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434 Adenoma Detection With Endocuff Colonoscopy vs Conventional Colonoscopy: a Multicenter Randomised Controlled Trial

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2015.03.1231 ◽

2015 ◽

Vol 81 (5) ◽

pp. AB145 ◽

Cited By ~ 2

Author(s):

Sascha C. Van Doorn ◽

Manon Van Der Vlugt ◽

Annekatrien C. Depla ◽

Caroline A. Wientjes ◽

Marco W. Mundt ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Conventional Colonoscopy ◽

Adenoma Detection ◽

Randomised Controlled

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Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial—study protocol

BMJ Open ◽

10.1136/bmjopen-2021-051269 ◽

2021 ◽

Vol 11 (7) ◽

pp. e051269

Author(s):

Laura Koskenvuo ◽

Pipsa Lunkka ◽

Pirita Varpe ◽

Marja Hyöty ◽

Reetta Satokari ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bowel Preparation ◽

Controlled Trial ◽

Rectal Surgery ◽

Mechanical Bowel Preparation ◽

Oral Antibiotic ◽

Oral Antibiotics ◽

Number Of Patients ◽

Randomised Controlled ◽

Double Blinded

IntroductionMechanical bowel preparation (MBP) prior to rectal surgery is widely used. Based on retrospective data many guidelines recommend mechanical and oral antibiotic bowel preparation (MOABP) to reduce postoperative complications and specifically surgical site infections (SSIs). The primary aim of this study is to examine whether MOABP reduces complications of rectal surgery.Methods and analysisThe MOBILE2 (Mechanical Bowel Preparation and Oral Antibiotics vs Mechanical Bowel Preparation Only Prior Rectal Surgery) trial is a multicentre, double-blinded, parallel group, superiority, randomised controlled trial comparing MOABP to MBP among patients scheduled for rectal surgery with colorectal or coloanal anastomosis. The patients randomised to the MOABP group receive 1 g neomycin and 1 g metronidazole two times on a day prior to surgery and patients randomised to the MBP group receive identical placebo. Based on power calculations, 604 patients will be enrolled in the study. The primary outcome is Comprehensive Complication Index within 30 days after surgery. Secondary outcomes are SSIs within 30 days after surgery, the number and classification of anastomosis dehiscences, the length of hospital stay, mortality within 90 days after surgery and the number of patients who received adjuvant treatment if needed. Tertiary outcomes are overall survival, disease-specific survival, recurrence-free survival and difference in quality-of-life before and 1 year after surgery. In addition, the microbiota differences in colon mucosa are analysed.Ethics and disseminationThe Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT04281667.

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Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-041673 ◽

2021 ◽

Vol 11 (7) ◽

pp. e041673

Author(s):

Nicole E M Jaspers ◽

Frank L J Visseren ◽

Yolanda van der Graaf ◽

Yvo M Smulders ◽

Olga C Damman ◽

...

Keyword(s):

Decision Making ◽

Randomised Controlled Trial ◽

Life Expectancy ◽

Statin Therapy ◽

Controlled Trial ◽

Decisional Conflict ◽

P Value ◽

Cvd Risk ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

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Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽

10.1136/bmjopen-2020-042101 ◽

2020 ◽

Vol 10 (12) ◽

pp. e042101

Author(s):

Saba Aijaz ◽

Sana Sheikh ◽

Asad Pathan

Keyword(s):

Randomised Controlled Trial ◽

Radial Artery ◽

Controlled Trial ◽

Coronary Intervention ◽

Ease Of Use ◽

P Value ◽

Radial Compression ◽

Open Label ◽

Scientific Publications ◽

Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

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T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX)

BMJ Open ◽

10.1136/bmjopen-2020-042619 ◽

2020 ◽

Vol 10 (11) ◽

pp. e042619

Author(s):

Arnaud W Thille ◽

Rémi Coudroy ◽

Arnaud Gacouin ◽

Stephan Ehrmann ◽

Damien Contou ◽

...

Keyword(s):

High Risk ◽

Randomised Controlled Trial ◽

Pressure Support Ventilation ◽

Spontaneous Breathing ◽

Pressure Support ◽

Controlled Trial ◽

Invasive Mechanical Ventilation ◽

Support Ventilation ◽

Number Of Patients ◽

Randomised Controlled

IntroductionIn intensive care unit (ICU), the decision of extubation is a critical time because mortality is particularly high in case of reintubation. To reduce that risk, guidelines recommend to systematically perform a spontaneous breathing trial (SBT) before extubation in order to mimic the postextubation physiological conditions. SBT is usually performed with a T-piece disconnecting the patient from the ventilator or with low levels of pressure-support ventilation (PSV). However, work of breathing is lower during PSV than during T-piece. Consequently, while PSV trial may hasten extubation, it may also increase the risk of reintubation. We hypothesise that, compared with T-piece, SBT performed using PSV may hasten extubation without increasing the risk of reintubation.Methods and analysisThis study is an investigator-initiated, multicentre randomised controlled trial comparing T-piece vs PSV for SBTs in patients at high risk of reintubation in ICUs. Nine hundred patients will be randomised with a 1:1 ratio in two groups according to the type of SBT. The primary outcome is the number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation between the initial SBT (day 1) and day 28. Secondary outcomes include the number of days between the initial SBT and the first extubation attempt, weaning difficulty, the number of patients extubated after the initial SBT and not reintubated within the following 72 hours, the number of patients extubated within the 7 days following the initial SBT, the number of patients reintubated within the 7 days following extubation, in-ICU length of stay and mortality in ICU, at day 28 and at day 90.Ethics and disseminationThe study has been approved by the central ethics committee ‘Ile de France V’ (2019-A02151-56) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04227639.

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User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial

Injury Prevention ◽

10.1136/injuryprev-2019-043380 ◽

2019 ◽

Vol 26 (5) ◽

pp. 432-438 ◽

Cited By ~ 2

Author(s):

Alexandra B Hall ◽

Catherine Ho ◽

Bianca Albanese ◽

Lisa Keay ◽

Kate Hunter ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Instructional Materials ◽

Control Group ◽

P Value ◽

Point Increase ◽

Comprehension Score ◽

Child Restraint ◽

Randomised Controlled

BackgroundIncorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.MethodsWe used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.ResultsThere was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI −2.7% to −1.0%) reduction in errors (y=45.5–1.87x, p value for slope <0.001).ConclusionsConsumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.

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Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25° head-up position and supine: the InSize25 study protocol

BMJ Open ◽

10.1136/bmjopen-2019-029761 ◽

2019 ◽

Vol 9 (11) ◽

pp. e029761

Author(s):

Anne-Sophie Falempin ◽

Bruno Pereira ◽

Fatima Binakdane ◽

Jean-Etienne Bazin ◽

Margot Smirdec

Keyword(s):

Randomised Controlled Trial ◽

Tracheal Intubation ◽

Direct Laryngoscopy ◽

Controlled Trial ◽

Outcome Variable ◽

Ethical Review ◽

Obese Patients ◽

Open Label ◽

Number Of Patients ◽

Randomised Controlled

IntroductionDifficult airway management during tracheal intubation can lead to severe hypoxic sequelae. Routine intubation practice is to use a strict supine position, whereas a 25° head-up or reverse Trendelenburg position increases efficacy of preoxygenation, seems more comfortable for the anaesthetist and may also provide better intubation conditions in direct laryngoscopy. The 25° head-up position could be used for the whole population rather than only for obese patients, but there is no prospective randomised controlled trial with a robust design and large number of patients comparing strict supine against 25° intubation in operating room. The objective of the InSize25 study is to test the effect of these two patient positions on intubation conditions during laryngoscopy in scheduled surgery on non-obese patients.Methods and analysisInSize25 is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial. The InSize25 study will randomise 1000 adult patients scheduled for surgery under general anaesthesia requiring intubation with neuromuscular-blocking drugs, candidates for direct laryngoscopy. The primary outcome variable is the view obtained during the first laryngoscopy without any external manipulation assessed using percentage of glottic opening. Important secondary outcomes are: Cormack-Lehane classification, number of attempts at laryngoscopy and at tracheal intubation, use of ancillary equipment (eg, bougies, alternative laryngoscope blades, videolaryngoscope) and manoeuvres (eg, laryngeal manipulation), comfort score for the anaesthetist, episodes of postinduction hypotension or desaturation and mechanical complications of intubation.Ethics and disseminationThe trial received appropriate approval from the ‘CPP Sud-Est II’ ethical review board. Informed consent is required. If the 25° head-up position proves superior for tracheal intubation without more complications, it may become the routine-standard intubation position rather than only for use with obese patients. The final results will be published in a peer-reviewed journal.Trial registration numberClinicaltrials.gov identifier (NCT03339141).

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Role of Predonation Hydration in the Prevention of Postdonation Vasovagal Reactions in First Time Blood Donors: A Randomised Controlled Trial

JOURNAL FOR CLINICAL AND DIAGNOSTIC RESEARCH ◽

10.7860/jcdr/2021/47675.15447 ◽

2021 ◽

Author(s):

Vijayalakshmi Kuttath ◽

Harikumaran Nair ◽

Muraleedharan Nair

Keyword(s):

Sensitivity Analysis ◽

Randomised Controlled Trial ◽

Blood Donors ◽

Blood Donation ◽

Controlled Trial ◽

Statistical Significance ◽

P Value ◽

Vasovagal Reactions ◽

Randomised Controlled ◽

First Time

Introduction: A crucial component of the effort to meet the growing demand for blood is the recruitment and retention of young novice blood donors. Reducing postdonation syncopal reactions could have a beneficial impact on donor convenience, safety, and desire to donate again. Aim: To evaluate the effectiveness of predonation hydration over standard blood donation in the prevention or decrease in severity of postdonation Vasovagal Reactions (VVR) in hydrated blood donors in comparison with the non hydrated group. Materials and Methods: The randomised controlled trial was conducted on 953 first time voluntary blood donors. Donors in the intervention arm drank 250 mL water 30 minutes before blood donation, while those in the control group did not receive any intervention. Blood was collected by standard protocol. Outcome, VVR, if present was graded as mild, moderate, and severe. Analysis of results were done using Statistical Package for the Social Sciences (SPSS) version 16.0. A sensitivity analysis was also done to consider the dropouts from the study. Results: A total of 900 participants were included in the study, of which 443 were controls and 457 were cases. An effect size of 6.1%, a Relative Risk (RR) of 0.54 {95% Confidence Interval (CI)=0.36-0.81} and a risk reduction of 45% was arrived at, pointing to a protective role for predonation hydration in preventing VVR. There was a significant reduction in the severity of VVR in the predonation hydration group compared to the standard blood donation group (p-value=0.002). The protective effect of hydration on decreasing the occurrence and severity of VVR had statistical support in males in the moderate and severe grades (p-value=0.017). A similar statistical significance was not established in females (p-value=0.173). Sensitivity analysis did not reveal a difference in the statistical significance of variables between compared groups. Conclusion: Predonation hydration was found to be effective in preventing and decreasing the severity of VVR in novice blood donors.

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