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Results for “randomised controlled trial”

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At least 19 recordsLinked to original sources

PubMed1977

"Right" stay in hospital after sugery: randomised controlled trial.

A randomised controlled trial was carried out on 100 patients to compare the effects of discharge after certain pre-specified clinical criteria had been fulfilled--"right" stay--with those of discharge at an arbitrary 10 days after surgery--"fixed" stay. The operations concerned (cholecystectomy and vagotomy) were more hazardous than those previously included in studies of early discharge. Patients in the right-stay group were discharged, on average, 7-6 days after operation--that is, two days earlier than those in the fixed-stay group. In terms of clinical progress, social factors such as return to work, and the acceptability to patients and relatives of the implications of right stay, patients in this group fared as well as those in the fixed-stay group, and in some respects slightly better. Right stay entailed the transfer of some work from hospital to community medical and nursing staff, but this also was acceptable. The concept and use of the right-stay principle is of value in planning the postoperative discharge of suitable patients.

Adult↗

PubMed1978

Cimetidine for recurrent ulcer after vagotomy or gastrectomy: a randomised controlled trial.

In a randomised controlled trial cimetidine 1 g daily for six weeks was compared with placebo in the treatment of recurrent ulcers after gastrectomy or vagotomy for duodenal ulcer. Healing, assessed endoscopically, was seen in seven out of 12 patients given cimetidine and in five out of 12 controls. Four of the controls whose ulcers did not heal were subsequently treated with cimetidine, and in two the ulcers healed after six weeks. Pain recorded by the patient and consumption of alkalis were each slightly but not significantly less in the cimetidine-treated patients. When cimetidine is to be used for recurrent ulceration probably the dosage and duration of treatment should be increased.

Cimetidine↗

PubMed2026

Foot exercise plus education versus brief advice for the treatment of plantar heel pain (FEET Trial): a feasibility randomised controlled trial.

BACKGROUND: Despite foot muscle strengthening being a target of exercise interventions for plantar heel pain (PHP) no study has measured foot muscle outcomes, and existing research is limited by a lack of control (no treatment) comparisons. OBJECTIVES: To determine the feasibility of conducting a randomised controlled trial and investigate the acceptability and credibility of comprehensive progressive foot exercise and education compared to brief advice for PHP. DESIGN: Randomised parallel group feasibility trial. METHOD: People with PHP were randomised (1:1 concealed allocation) to receive either foot exercise plus education or brief advice for twelve weeks. Primary outcomes included willingness to enrol, recruitment rate, adherence, logbook completion, dropout rate, early withdrawal reasons, adverse events, additional treatments sought, and credibility/expectancy. RESULTS: Twenty people with PHP (16 women; age 50 ± 9 years; body mass index = 30.7 ± 4.6 kg/m2) were recruited over 15 weeks (1.3 participants per week). Primary outcomes were willingness to enrol (80%), adherence (physiotherapy sessions attended: foot exercise plus education 85%, brief advice 100%; home exercise program: 62% daily sessions completed, 72% thrice weekly sessions completed), logbook completion (foot exercise plus education 75%, brief advice 90%), dropout rate (15%), and additional treatments sought (69%). There were no intervention-related adverse events, and credibility scores were higher for foot exercise plus education. CONCLUSIONS: This study confirms feasibility and acceptability of a protocol comparing foot exercise plus education with brief advice in individuals with PHP, generating key insights to inform future trial design.

Humans↗

PubMed2026

Effects of single-injection vs. continuous brachial plexus blocks for shoulder surgeries on patient-reported outcomes: a systematic review and meta-analysis with trial sequential analysis of randomised controlled trials.

INTRODUCTION: Single-injection and continuous brachial plexus block techniques are used widely for postoperative analgesia in patients undergoing shoulder surgery. Although patient-reported outcomes are described in individual studies, their effects have not been synthesised comprehensively using a patient-centred framework. We sought to compare the effects of single-injection vs. continuous brachial plexus block techniques on patient-reported outcomes in adult patients following elective shoulder surgery. METHODS: Databases were searched from inception to October 2025 and randomised controlled trials reporting patient-reported outcomes were included. Co-primary outcomes were postoperative patient-reported pain intensity at rest and during movement at 12 h, 24 h and 48 h post-surgery. Secondary outcomes included nausea and vomiting; sleep quality; patient satisfaction; opioid requests; and functional scores. Random-effects meta-analysis and trial sequential analysis were performed, with risk of bias and quality of patient-reported outcome reporting assessed. RESULTS: Twenty randomised controlled trials that included 1198 patients were analysed. Continuous brachial plexus blocks were associated with lower pain at rest at 12 h, 24 h and 48 h, with mean differences (MD) of -1.96 (95%CI -2.81 to -1.11, p < 0.001), -1.66 (95%CI -2.27 to -1.05, p < 0.001) and - 1.18 (95%CI -1.84 to -0.53, p < 0.001), respectively. Pain on movement could only be pooled at 24 h and 48 h and showed MD -2.04 (95%CI -4.26-0.19, p = 0.07) and - 1.30 (95%CI -3.67-1.07, p = 0.28) respectively. The co-primary outcomes approached or exceeded the predefined minimal clinically important difference for pain scores after shoulder surgery, in favour of continuous techniques. DISCUSSION: Continuous brachial plexus blocks are associated with better pain at rest and other patient-centred outcomes following shoulder surgery, while effects on dynamic pain and long-term functional recovery remain uncertain.

Humans↗

PubMed1990

Heat probe thermocoagulation and pure alcohol injection in massive peptic ulcer haemorrhage: a prospective, randomised controlled trial.

We conducted a prospective randomised controlled trial of 137 patients with massive peptic ulcer haemorrhage over a period of 12 months to compare the haemostatic effects of endoscopic heat probe thermocoagulation and pure alcohol injection. Seventy eight patients (56.9%) were in shock at the time of randomisation to the trial. The age, sex, number of patients in shock, haemoglobin value at the time of entry to the trial, number of patients with severe medical illness, location of bleeders, and stigmata of recent haemorrhage were comparable among the heat probe, pure alcohol, and control groups. The initial haemostatic effect of the heat probe was better than that of the pure alcohol injection (44 of 45 v 31 of 46, p = 0.0004). The ultimate haemostasis achieved by the heat probe group (41 of 45) was better than that of the pure alcohol group (31 of 46, p = 0.012) and of controls (24 of 46, p = 0.0001). The duration of hospital stay was shorter for patients in the heat probe group than for the control group (6.2 days v 13.8 days, p less than 0.05). The incidence of emergency surgery was less for the heat probe than the control group (three of 45 v 12 of 46, p = 0.027). The mortality rate was less in the heat probe than in the control group (one of 45 v seven of 46, p = 0.031). We suggest that heat probe thermocoagulation should be the first treatment of choice for arrest of massive peptic ulcer haemorrhage.

Electrocoagulation↗

PubMed1977

Endothelial cell loss and corneal thickness after intracapsular extraction and iris clip lens implantation: a randomised controlled trial (interim report).

Patients in a randomised controlled trial were chosen either to have iris clip lens implantation after intracapsular cataract extraction or intracapsular extraction only. They were assessed in terms of corneal thickness, postoperative epithelial oedema, and endothelial cell counts. All patients had 1 eye submitted to operation, which was carried out by the same surgeon. There was significantly greater increase in corneal thickness (P less than 0.05) on the 5th postoperative day in eyes which had lens implants (23 patients with intracapsular extraction and 19 with implant), but the difference between the 2 groups became insignificant at 1 month (17 patients in each group). Daily corneal thickness measurements and observations of epithelial oedema in a subgroup (20 patients divided equally into 2 groups) showed that postoperatively there was greater and more widespread corneal oedema after implant surgery. When the operated eye was compared with the unoperated eye, endothelial cell loss was significantly greater in those with implants (P less than 0.01) than in those with simple intracapsular extraction.

Aged↗

PubMed2026

EDucation and eXercise for gluteal tendinopathy in an Irish context (EDX-Ireland): findings from the LEAP-Ireland feasibility randomised controlled trial.

OBJECTIVE: To assess feasibility of a randomised controlled trial (RCT) investigating effectiveness of 6 sessions of an EDucation and eXercise intervention delivered over 8 weeks (EDX-Ireland) for gluteal tendinopathy, against usual care. EDX-Ireland was modified from a 14-session EDucation and eXercise intervention (EDX), delivered over 8 weeks, previously evaluated in an Australian RCT. DESIGN: Feasibility parallel RCT. METHODS: Participants were randomly assigned to physiotherapist-led EDX-Ireland or usual care. EDX-Ireland comprised 6 sessions of education, hip abductor strengthening and functional loading over 8 weeks, supported by a home exercise programme. Primary outcomes included success of different recruitment strategies and recruitment/retention rates. Secondary outcomes measured global rating of change and other clinical outcomes. Descriptive statistics (percentage, mean, standard deviations and 95% confidence intervals (CI)) are presented. RESULTS: Of 323 individuals who expressed interest in study participation, 119 completed physical examination screening, and 65 met criteria and consented to participate (recruitment rate 55%). Sixty-five people (89% women; mean age 53.1 ± 9.3 years), were randomised to EDX-Ireland (n = 32) or usual care (n = 33). Eighty-three percent (n = 54) were recruited via social media/community, 3% (n = 2) from general practitioners and 14% (n = 9) from orthopaedic/rheumatology. Retention was 92% (95% CI 82-97%, n = 60) at 8-weeks, and 89% (95% CI 79-96%, n = 58) at 3-months. Feasibility thresholds were met. Effect size estimates indicate that 134 participants would be required for a future RCT. CONCLUSION: Pre-defined recruitment and retention thresholds were met, indicating that a RCT evaluating 6 sessions of physiotherapist-delivered education and exercise against usual care for gluteal tendinopathy is feasible. TRIAL REGISTRATION: Clinicaltrials.gov (NCT05516563).

Humans↗

PubMed1986

Vegetarian diet in mild hypertension: a randomised controlled trial.

In a randomised crossover trial 58 subjects aged 30-64 with mild untreated hypertension were allocated either to a control group eating a typical omnivorous diet or to one of two groups eating an ovolactovegetarian diet for one of two six week periods. A fall in systolic blood pressure of the order of 5 mm Hg occurred during the vegetarian diet periods, with a corresponding rise on resuming a meat diet. The main nutrient changes with the vegetarian diet included an increase in the ratio of polyunsaturated to saturated fats and intake of fibre, calcium, and magnesium and a decrease in the intake of protein and vitamin B12. There were no consistent changes in urinary sodium or potassium excretion or body weight. In untreated subjects with mild hypertension, changing to a vegetarian diet may bring about a worthwhile fall in systolic blood pressure.

Adult↗

PubMed1988

Quality of life on angina therapy: a randomised controlled trial of transdermal glyceryl trinitrate against placebo.

In a randomised controlled trial in 427 men with chronic stable angina continuous use of 5 mg transdermal glyceryl trinitrate (GTN) showed no advantage over placebo in terms of efficacy (anginal attack rates and sublingual GTN consumption) or quality of life (as measured with the sickness impact profile and a health index of disability). Patients on the active drug reported headaches more frequently than patients on placebo, and a higher proportion of them withdrew from the trial because of headache. Quality-of-life measurements showed a significant adverse effect of active treatment, principally in the social interaction dimension of the sickness impact profile. A similar effect was observed in placebo patients when crossed to active treatment in a 4-week single-blind period. The results suggest no benefit in the relief of chest pain from 5 mg transdermal GTN when used continuously.

Administration, Cutaneous↗

PubMed1986

Cataract surgery: interim results and complications of a randomised controlled trial. Oxford Cataract Treatment and Evaluation Team (OCTET).

A randomised controlled trial in progress for more than five years, with no loss to follow-up (except death), assessed 333 eyes treated by three methods of cataract surgery. They were (A) intracapsular extraction and contact lens usage, (B) intracapsular extraction and implantation of an iris supported lens (Federov I), and (C) extracapsular extraction and implantation of an iridocapsular lens (Binkhorst 2-loop). The purpose of the paper is to report interim visual results, complications, and corneal endothelial cell loss. More eyes in groups A (contact lens) and C (extracapsular + implant) achieved better visual acuity than in group B (intracapsular + Federov lens), which also had more postoperative complications. Both implant groups lost more endothelial cells than the non-implant group, which did not differ significantly from group B before one year.

Aged↗

PubMed1977

Randomised controlled trial of anti-smoking advice in pregnancy.

In a randomised controlled trial intensive individual anti-smoking advice given in parallel with hospital antenatal care did not influence the outcome of pregnancy. The belief that retardation of fetal growth caused by maternal smoking occurs in late pregnancy is not well based, and the advice may not have been given in time to be effective. Other possible interpretations of the results, that maternal smoking is merely an index of some other factor that retards growth or that those counselled did not reduce their smoking sufficiently to influence outcome, cannot be excluded.

Birth Weight↗

PubMed1978

Randomised controlled trial of early discharge for inguinal hernia and varicose veins.

A randomised controlled trial has been conducted into the effects of discharging patients from hospital either 48 hours or six to seven days after operations for inguinal hernia and varicose veins. There was no statistically significant difference in major postoperative complications between the two lengths of stay for either of the two conditions. Similarly there was no difference between the two groups of hernia patients in relation to eventual recurrences. There was no significant difference in length of convalescence between long-stay and short-stay patients in full-time occupations. The savings to the statutory services of discharging patients early were estimated at 25.72 pounds per patient. Patients appeared to approve of the type of care they experienced, regardless of length of stay. However, the families of short-stay patients were significantly less enthusiastic in their attitudes towards the policy of early discharge than the families of long-stay patients.

Adolescent↗

PubMedDate not supplied

Accidents in elderly care: a randomised controlled trial (Part 1).

This paper reports the data on accidents from a randomised controlled trial evaluating health authority-funded nursing home and long stay care of the elderly ward care in one inner London health district. Respondents randomised to NHS nursing homes experienced a higher accident rate than respondents randomised to conventional long stay hospital wards for elderly people. Respondents in the homes also experienced an earlier decline in functional and mental ability than those in hospital. These disadvantages have to be balanced against the previously published observational data from the evaluation, which clearly indicated that quality of life in the homes was superior to that in the wards. The conclusion from this study is that earlier decline in functional and mental ability and increased accident risk in the more flexible environments of the nursing homes have to be balanced against an inferior quality of life in the large hospital long stay wards.

Accidental Falls↗

PubMedDate not supplied

Accidents in elderly care: a randomised controlled trial (Part 2).

Accidental Falls↗

PubMedDate not supplied

Accidents in elderly care: a randomised controlled trial (part 3).

Accidental Falls↗

PubMed1986

Use of a grading system in the evaluation of complications in a randomised controlled trial on cataract surgery. Oxford Cataract Treatment and Evaluation Team (OCTET).

A randomised controlled trial in progress for more than five years assessed 333 eyes by three methods of cataract surgery. These were (A) intracapsular extraction and contact lens usage; (B) intracapsular extraction and implantation of an iris supported lens (Federov I); and (C) extracapsular extraction and implantation of an iridocapsular lens (Binkhorst 2-loop). This paper reports the use of a weighting scale for rank scoring complications which are dissimilar or are mutually exclusive (for example, capsular versus contact lens problems) to allow the use of non-parametric statistics for comparing disparate features. Thus we found that group B did significantly worse in terms of the number and severity of postoperative complications, a trend in accordance with visual results. This method may serve as a useful model for similar studies.

Aged↗

PubMed1987

Meta-analysis of randomised controlled trials of nicotine chewing-gum.

A meta-analysis was made of fourteen randomised controlled trials that evaluated the efficacy of nicotine chewing-gum in stopping patients smoking. The combined success rates in specialised cessation clinics are significantly higher with nicotine gum (27%) than with placebo gum (18%) at 6 months (n = 734), and 23% and 13% at 12 months, respectively. In contrast, success rates in general medical practices are similar with nicotine gum (11.4%) and with placebo gum (11.7%) at 6 months (n = 1022). However, in general practices, the success rates are 17% for nicotine gum and 13% for the no gum control at 4-6 months, and 9% and 5% at 12 months, a significant difference between the treatments at each time (n = 2238). The data suggest that proper use of nicotine gum in specialised clinics will increase the rate of stopping patients smoking. The use of the gum in general medical practices is questionable.

Carbon Monoxide↗

PubMed1992

Randomised controlled trial of Doppler ultrasound screening of placental perfusion during pregnancy.

We have done a randomised controlled trial to assess the effect on primary management and outcome of routine doppler ultrasound examinations of the umbilical and uterine arteries during pregnancy. Over 9 months, 2600 women with singleton pregnancies were recruited from a general obstetric population. Of 2475 women who delivered in hospital after 20 weeks' gestation, 1246 had been allocated at random to receive standard antenatal care with routine doppler examinations. The first doppler ultrasound was done at 19-22 weeks' gestation, and thereafter examinations were monthly if the pregnancy was considered high risk (192) or once at 32 weeks if considered low risk (1054). The control group of 1229 women received standard, antenatal care without doppler ultrasonography. The study groups did not differ in number of antenatal admissions or cardiotocographs, gestational age at delivery, method of delivery, frequency of deliveries with fetal distress, or need for resuscitation or admission to the neonatal intensive care unit. More perinatal deaths occurred in the doppler group (17 vs 7, relative risk 2.4, 95% Cl 1.00-5.76), but only 1 of 11 normally formed stillbirths and none of the 4 normally formed neonatal deaths after 24 weeks' gestation had an abnormal umbilical-artery doppler examination. We did not demonstrate any improvement in neonatal outcome by routine doppler ultrasound screening of a general obstetric population.

Adult↗