Microinterventional endocapsular nucleus disassembly: novel technique and results of first-in-human randomised controlled study

AimTo assess the safety and efficacy of microinterventional endocapsular nuclear fragmentation in moderate to severe cataracts.MethodsThis was a prospective single-masked multisurgeon interventional randomised controlled trial (ClinicalTrials.gov NCT02843594) where 101 eyes of 101 subjects with grade 3‒4+ nuclear cataracts were randomised to torsional phacoemulsification alone (controls) or torsional phacoemulsification with adjunctive endocapsular nuclear fragmentation using a manual microinterventional nitinol filament loop device (miLOOP group). Outcome measures were phacoemulsification efficiency as measured by ultrasound energy (cumulative dispersed energy (CDE) units) and fluidics requirements (total irrigation fluid used) as well as incidence of intraoperative and postoperative complications.ResultsOnly high-grade advanced cataracts were enrolled with more than 85% of eyes with baseline best corrected visual acuity (BCVA) of 20/200 or worse in either group. Mean CDE was 53% higher in controls (32.8±24.9 vs 21.4±13.1 with miLOOP assistance) (p=0.004). Endothelial cell loss after surgery was low and similar between groups (7‒8%, p=0.561) One-month BCVA averaged 20/27 Snellen in miLOOP eyes and 20/24 in controls. No direct complications were caused by the miLOOP. In two cases, capsular tears occurred during IOL implantation and in all remaining cases during phacoemulsification, with none occurring during the miLOOP nucleus disassembly part of the procedure.ConclusionsMicrointerventional endocapsular fragmentation with the manual, disposable miLOOP device achieved consistent, ultrasound-free, full-thickness nucleus disassembly and significantly improved overall phaco efficiency in advanced cataracts.Trial registration numberNCT02843594

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Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽

10.1177/0267659117715507 ◽

2017 ◽

Vol 32 (7) ◽

pp. 591-597 ◽

Cited By ~ 5

Author(s):

Geoff G. Lockwood ◽

Leilani Cabreros ◽

Dorota Banach ◽

Prakash P. Punjabi

Keyword(s):

Cardiac Surgery ◽

Primary Outcome ◽

Controlled Trial ◽

Morphine Consumption ◽

Controlled Study ◽

Double Blind ◽

Clinical Trial Registration ◽

Subcutaneous Infusion ◽

Randomised Controlled Study ◽

Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

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A Controlled Trial of Home-Based Acute Psychiatric Services

The British Journal of Psychiatry ◽

10.1192/bjp.163.1.49 ◽

1993 ◽

Vol 163 (1) ◽

pp. 49-54 ◽

Cited By ~ 90

Author(s):

Tom Burns ◽

Alan Beadsmoore ◽

Ashok V. Bhat ◽

Andrew Oliver ◽

Carola Mathers

Keyword(s):

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Community Based ◽

Home Based ◽

Randomised Controlled Study ◽

One Year ◽

Randomised Controlled ◽

Clinical Measures ◽

Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

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Effects of nasal lavage with and without mupirocin after endoscopic endonasal skull base surgery: a randomised, controlled study

The Journal of Laryngology & Otology ◽

10.1017/s0022215119002329 ◽

2019 ◽

Vol 133 (12) ◽

pp. 1059-1063

Author(s):

B H K Ng ◽

I P Tang ◽

P Narayanan ◽

R Raman ◽

R L Carrau

Keyword(s):

Skull Base ◽

Skull Base Surgery ◽

Controlled Trial ◽

Nasal Lavage ◽

Nasal Endoscopy ◽

Controlled Study ◽

Endoscopic Endonasal ◽

Randomised Controlled Study ◽

Skull Base Lesions ◽

Randomised Controlled

AbstractBackgroundNasal lavage with mupirocin has the potential to reduce sinonasal morbidity in endoscopic endonasal approaches for skull base surgery.ObjectiveTo evaluate the effects of nasal lavage with and without mupirocin after endoscopic endonasal skull base surgery.MethodsA pilot randomised, controlled trial was conducted on 20 adult patients who had undergone endoscopic endonasal approaches for skull base lesions. These patients were randomly assigned to cohorts using nasal lavages with mupirocin or without mupirocin. Patients were assessed in the out-patient clinic, one week and one month after surgery, using the 22-item Sino-Nasal Outcome Test questionnaire and nasal endoscopy.ResultsPatients in the mupirocin nasal lavage group had lower nasal endoscopy scores post-operatively, and a statistically significant larger difference in nasal endoscopy scores at one month compared to one week. The mupirocin nasal lavage group also showed better Sino-Nasal Outcome Test scores at one month compared to the group without mupirocin.ConclusionNasal lavage with mupirocin seems to yield better outcomes regarding patients’ symptoms and endoscopic findings.

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Thermoregulatory effects of swaddling in Mongolia: a randomised controlled study

Archives of Disease in Childhood ◽

10.1136/archdischild-2014-307908 ◽

2015 ◽

Vol 101 (2) ◽

pp. 152-160 ◽

Cited By ~ 2

Author(s):

Bazarragchaa Tsogt ◽

Semira Manaseki-Holland ◽

Jon Pollock ◽

Peter S Blair ◽

Peter Fleming

Keyword(s):

Cold Stress ◽

Controlled Trial ◽

Sleep Onset ◽

Controlled Study ◽

Diurnal Pattern ◽

Total Thermal Resistance ◽

Reverse Pattern ◽

Registration Number ◽

Randomised Controlled ◽

Peripheral Temperature

ObjectiveTo investigate thermal balance of infants in a Mongolian winter, and compare the effects of traditional swaddling with an infant sleeping-bag in apartments or traditional tents (Gers).DesignA substudy within a randomised controlled trial.SettingCommunity in Ulaanbaatar, Mongolia.SubjectsA stratified randomly selected sample of 40 swaddled and 40 non-swaddled infants recruited within 48 h of birth.InterventionSleeping-bags and baby outfits of total thermal resistance equivalent to that of swaddled babies.Outcome measureDigital recordings of infants’ core, peripheral, environmental and microenvironmental temperatures at 30-s intervals over 24 h at ages 1 month and 3 months.ResultsIn Gers, indoor temperatures varied greatly (<0–>25°C), but remained between 20°C and 22°C, in apartments. Despite this, heavy wrapping, bed sharing and partial head covering, infant core and peripheral temperatures were similar and no infants showed evidence of significant heat or cold stress whether they were swaddled or in sleeping-bags. At 3 months, infants in sleeping-bags showed the ‘mature’ diurnal pattern of a fall in core temperature after sleep onset, accompanied by a rise in peripheral temperature, with a reverse pattern later in the night, just before awakening. This pattern was not related to room temperature, and was absent in the swaddled infants, suggesting that the mature diurnal pattern may develop later in them.ConclusionsNo evidence of cold stress was found. Swaddling had no identifiable thermal advantages over sleeping-bags during the coldest times, and in centrally heated apartments could contribute to the risk of overheating during the daytime.Trial registration numberISRTN01992617.

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Tocilizumab discontinuation after attaining remission in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate: results from a prospective randomised controlled study (the second year of the SURPRISE study)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2018-213416 ◽

2018 ◽

Vol 77 (9) ◽

pp. 1268-1275 ◽

Cited By ~ 19

Author(s):

Yuko Kaneko ◽

Masaru Kato ◽

Yoshiya Tanaka ◽

Masayuki Inoo ◽

Hitomi Kobayashi-Haraoka ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Controlled Study ◽

Sustained Remission ◽

Open Label ◽

Low Disease Activity ◽

Randomised Controlled Study ◽

Registration Number ◽

Second Year ◽

Randomised Controlled

ObjectiveTo evaluate the sustained remission and low disease activity after discontinuation of tocilizumab in patients with rheumatoid arthritis who were treated with tocilizumab alone or in combination with methotrexate.MethodsThe SURPRISE study was a 2-year, open-label randomised controlled study. Among patients who had been randomised to additional tocilizumab (ADD-ON) or switch to tocilizumab (SWITCH) in the first year, those who achieved remission based on the disease activity score for 28 joints (DAS28-ESR<2.6) discontinued tocilizumab at week 52 and were observed for the following 52 weeks. The endpoint of the second year included tocilizumab-free remission and low disease-activity rates, functional outcome, radiological outcomes assessed with the modified total Sharp score (mTSS) and safety. The efficacy of reinstituted tocilizumab/methotrexate was also evaluated.ResultsA total of 105 patients who achieved remission at week 52 discontinued tocilizumab; 51 in ADD-ON continued methotrexate and 54 in SWITCH received no disease-modifying antirheumatic drugs. Sustained DAS28 low disease-activity rates were significantly higher in ADD-ON than in SWITCH (55%vs27%, p=0.005). Sustained remission rates at week 104 were 24% for ADD-ON and 14% for SWITCH (p=0.29). Radiological progression was comparable between both groups (mTSS; 0.37vs0.64, p=0.36). The restart of tocilizumab induced remission in all except two patients after 36 weeks, irrespective of concomitant methotrexate.ConclusionSustained low disease activity after tocilizumab discontinuation could be maintained with continued methotrexate in more than half of the patients. Retreatment with tocilizumab led to remission in more than 90% of patients.Trial registration numberNCT01120366; Results.

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Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention (EMT-OCSP): a protocol for a pragmatic, multicentre, observer-blinded, 12-month randomised controlled study

BMJ Open ◽

10.1136/bmjopen-2020-043450 ◽

2021 ◽

Vol 11 (3) ◽

pp. e043450

Author(s):

Muke Zhou ◽

Jian Guo ◽

Ning Chen ◽

Mengmeng Ma ◽

Shuju Dong ◽

...

Keyword(s):

Cardiovascular Disease ◽

Risk Factor ◽

Message Framing ◽

Potential Interaction ◽

Controlled Study ◽

Cvd Risk ◽

Randomised Controlled Study ◽

Registration Number ◽

Randomised Controlled

IntroductionPrimary prevention of cardiovascular disease (CVD) and stroke often fails due to poor adherence among patients to evidence-based prevention recommendations. The proper formatting of messages portraying CVD and stroke risks and interventional benefits may promote individuals’ perception and motivation, adherence to healthy plans and eventual success in achieving risk control. The main objective of this study is to determine whether risk and intervention communication strategies (gain-framed vs loss-framed and long-term vs short-term contexts) and potential interaction thereof have different effects on the optimisation of adherence to clinical preventive management for the endpoint of CVD risk reduction among subjects with at least one CVD risk factor.Methods and analysisThis trial is designed as a 2×2 factorial, observer-blinded multicentre randomised controlled study with four parallel groups. Trial participants are aged 45–80 years and have at least one CVD risk factor. Based on sample size calculations for primary outcome, we plan to enrol 15 000 participants. Data collection will occur at baseline, 6 months and 1 year after randomisation. The primary outcomes are changes in the estimated 10-year CVD risk, estimated lifetime CVD risk and estimated CVD-free life expectancy from baseline to the 1-year follow-up.Ethics and disseminationThis study received approval from the Ethical Committee of West China Hospital, Sichuan University and will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT04450888.

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Effect of Acupuncture on Knee Function in Advanced Osteoarthritis of the Knee: A Prospective, Non-Randomised Controlled Study

Acupuncture in Medicine ◽

10.1136/aim.20.1.19 ◽

2002 ◽

Vol 20 (1) ◽

pp. 19-21 ◽

Cited By ~ 20

Author(s):

Abhay Tillu ◽

Sumedha Tillu ◽

Sarah Vowler

Keyword(s):

Controlled Trial ◽

Knee Function ◽

Controlled Study ◽

Control Group ◽

Osteoarthritis Of The Knee ◽

Randomised Controlled Study ◽

Total Knee ◽

Randomised Controlled ◽

Hss Score

We report a prospective controlled trial, comparing acupuncture with no treatment, in patients with advanced osteoarthritis of the knee awaiting total knee replacement. Knee function was assessed at the beginning of study and at the end of two months, using four parameters: HSS score, time to walk 50 metres, time to climb 20 steps, and degree of pain. Acupuncture was given at four local points around the knee and at one distal point. The acupuncture group improved in all parameters, whereas the control group deteriorated, a finding that was highly statistically significant (p<0.0002). Further randomised-controlled trials with longer follow-up are required to confirm these findings.

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A Prospective, Randomised, Controlled Trial Comparing Wound Dressings Used in Hip and Knee Surgery: Aquacel and Tegaderm Versus Cutiplast

Annals of The Royal College of Surgeons of England ◽

10.1308/003588406x82989 ◽

2006 ◽

Vol 88 (1) ◽

pp. 18-22 ◽

Cited By ~ 55

Author(s):

MJ Ravenscroft ◽

J Harker ◽

KA Buch

Keyword(s):

Randomised Controlled Trial ◽

Odds Ratio ◽

Elective Surgery ◽

Controlled Trial ◽

Wound Dressings ◽

Controlled Study ◽

Randomised Controlled Study ◽

Randomised Controlled ◽

To Receive ◽

Hip And Knee Surgery

INTRODUCTION Cutiplast (absorbent perforated dressing with adhesive border; Smith & Nephew) is commonly used following orthopaedic operation, but complications of its use have been reported. A prospective, randomised, controlled study was performed to compare the efficacy of Cutiplast versus an Aquacel (hydrofibre dressing; ConvaTec) covered with Tegaderm (vapour-permeable dressing; 3M). PATIENTS AND METHODS Two-hundred patients were randomised to receive one of the two dressings following elective and non-elective surgery of the hip and the knee. We were able to study 183 patients. The condition of the wound and any complications such as skin blistering or signs of infection was noted as was the frequency of dressing changes. RESULTS The Aquacel and Tegaderm dressing was 5.8 times more likely to result in a wound with no complications as compared to a Cutiplast dressing (odds ratio, 5.8; 95% CI 2.8–12.5; P < 0.00001). CONCLUSION Aquacel covered by Tegaderm is a superior dressing to Cutiplast following surgery to the hip and knee.

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Effects of high-oleic peanuts within a hypoenergetic diet on inflammatory and oxidative status of overweight men: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114519003246 ◽

2019 ◽

Vol 123 (6) ◽

pp. 673-680

Author(s):

Ana Paula Silva Caldas ◽

Raquel Duarte Moreira Alves ◽

Helen Hermana Miranda Hermsdorff ◽

Leandro Licursi de Oliveira ◽

Josefina Bressan

Keyword(s):

Inflammatory Markers ◽

Controlled Trial ◽

Daily Intake ◽

Oxidative Status ◽

Controlled Study ◽

High Oleic ◽

Randomised Controlled Study ◽

Randomised Controlled ◽

And Oxidative Stress ◽

High Oleic Peanuts

AbstractThe consumption of food with MUFA has been associated with improvement of inflammation and oxidative stress in overweight individuals. In the present study, we evaluate the effect of high-oleic peanut intake within a hypoenergetic diet on inflammatory and oxidative status markers in overweight men. Sixty-four overweight men (BMI 26–35 kg/m2, 18–50 years old) participated in this randomised controlled study for 4 weeks, allocated into three groups: control (CT, n 22), conventional peanut (CVP, n 21) and high-oleic peanut (HOP, n 21). They followed a hypoenergetic diet (−250 kcal/d; −1045 kJ/d) with or without 56 g of high-oleic or conventional peanuts. After the intervention, the inflammatory markers did not show significant changes in fasting concentrations or postprandial response among the experimental groups (P > 0·05). The activity of oxidative status markers remained unchanged after the intervention. However, in the CT, malondialdehyde showed lower concentration in comparison with the baseline (P = 0·020) and among the groups (P = 0·002). In the present study, the daily intake of high-oleic peanuts within a hypoenergetic diet did not modify the inflammatory markers and oxidative status in overweight men. More studies are needed to better understand the effect of high-oleic peanut intake on health outcomes.

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