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Results for “Randomised Controlled Trial”

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PubMed2005

A randomised controlled trial to evaluate the effect of self-administered analgesia on women's experience of outpatient treatment at colposcopy.

OBJECTIVE: To evaluate the effect of self-administered isoflurane and desflurane on women's experience of outpatient treatment at colposcopy. DESIGN: A prospective double-blinded randomised controlled trial. SETTING: A colposcopy clinic serving a regional population. POPULATION: Three hundred and ninety-six women scheduled for treatment of cervical intraepithelial neoplasia (CIN) by large loop excision of the transformation zone (LLETZ). METHODS: Self-administration of trial gas during a LLETZ procedure. One hundred and ninety-eight women were randomised to use isoflurane and desflurane and 198 to use placebo. MAIN OUTCOME MEASURES: Patient satisfaction, pain and anxiety. RESULTS: The mean pain score for cervical surgery was significantly lower for women using isoflurane and desflurane (22.4) than the placebo arm (29.6) (P= 0.003). There was no significant difference between arms in anxiety levels before or after treatment. More women using isoflurane and desflurane (78%) reported 'total helpfulness' of the trial gas than those using placebo (67%) (P= 0.012). A subgroup analysis of trial participants classified as anxious by Hospital Anxiety and Depression Scale (HADS) score at recruitment showed that using isoflurane and desflurane significantly increased total treatment acceptability, helpfulness of the gas and willingness to undergo a similar procedure at six-month follow up. CONCLUSION: Satisfaction with outpatient treatment at colposcopy is generally high. The main effect of isoflurane and desflurane evaluated in this trial was to reduce pain. It appeared to be effective for women with clinically significant anxiety and could be offered as an alternative to general anaesthesia.

Adult↗

PubMed1998

Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost.

OBJECTIVE: To compare tension-free open mesh hernioplasty under local anaesthetic with transabdominal preperitoneal laparoscopic hernia repair under general anaesthetic. DESIGN: A randomised controlled trial of 403 patients with inguinal hernias. SETTING: Two acute general hospitals in London between May 1995 and December 1996. SUBJECTS: 400 patients with a diagnosis of groin hernia, 200 in each group. MAIN OUTCOME MEASURES: Time until discharge, postoperative pain, and complications; patients' perceived health (SF-36), duration of convalescence, and patients' satisfaction with surgery; and health service costs. RESULTS: More patients in the open group (96%) than in the laparoscopic group (89%) were discharged on the same day as the operation (chi2 = 6.7; 1 df; P=0.01). Although pain scores were lower in the open group while the effect of the local anaesthetic persisted (proportional odds ratio at 2 hours 3.5 (2.3 to 5.1)), scores after open repair were significantly higher for each day of the first week (0.5 (0.3 to 0.7) on day 7) and during the second week (0.7 (0.5 to 0.9)). At 1 month there was a greater improvement (or less deterioration) in mean SF-36 scores over baseline in the laparoscopic group compared with the open group on seven of eight dimensions, reaching significance on five. For every activity considered the median time until return to normal was significantly shorter for the laparoscopic group. Patients randomised to laparoscopic repair were more satisfied with surgery at 1 month and 3 months after surgery. The mean cost per patient of laparoscopic repair was 335 pounds (95% confidence interval 228 pounds to 441 pounds) more than the cost of open repair. CONCLUSION: This study confirms that laparoscopic hernia repair has considerable short term clinical advantages after discharge compared with open mesh hernioplasty, although it was more expensive.

Activities of Daily Living↗

PubMed2004

Cervical cerclage for prevention of preterm delivery in women with short cervix: randomised controlled trial.

BACKGROUND: Cervical cerclage has been widely used in the past 50 years to prevent early preterm birth and its associated neonatal mortality and morbidity. Results of randomised trials have not generally lent support to this practice, but this absence of benefit may be due to suboptimum patient selection, which was essentially based on obstetric history. A more effective way of identifying the high-risk group for early preterm delivery might be by transvaginal sonographic measurement of cervical length. We undertook a multicentre randomised controlled trial to investigate whether, in women with a short cervix identified by routine transvaginal scanning at 22-24 weeks' gestation, the insertion of a Shirodkar suture reduces early preterm delivery. METHODS: Cervical length was measured in 47?123 women. The cervix was 15 mm or less in 470, and 253 (54%) of these women participated in the study and were randomised to cervical cerclage (127) or to expectant management (126). Primary outcome was the frequency of delivery before 33 completed weeks (231 days) of pregnancy. FINDINGS: The proportion of preterm delivery before 33 weeks was similar in both groups, 22% (28 of 127) in the cerclage group versus 26% (33 of 126) in the control group (relative risk=0.84, 95% CI 0.54-1.31, p=0.44), with no significant differences in perinatal or maternal morbidity or mortality. INTERPRETATION: The insertion of a Shirodkar suture in women with a short cervix does not substantially reduce the risk of early preterm delivery. Routine sonographic measurement of cervical length at 22-24 weeks identifies a group at high risk of early preterm birth.

Adult↗

PubMed2006

Effects of growth hormone and/or testosterone on very low density lipoprotein apolipoprotein B100 kinetics and plasma lipids in healthy elderly men: a randomised controlled trial.

OBJECTIVE: To assess the effects of low dose recombinant growth hormone (GH), testosterone (T) and combined GH and T, on lipid profiles and very low density lipoprotein apolipoprotein B (VLDL apoB) metabolism. DESIGN AND PATIENTS: Sixty-nine healthy elderly men (65-80 yr) were studied in a six month double-blind, placebo-controlled trial. Participants were randomised to placebo GH and placebo T (P), GH and placebo T (GH), T and placebo GH (T) or GH and T (GHT). MEASUREMENTS: Plasma lipid profiles were assessed before treatment and at 6 months. VLDL apoB absolute secretion rate (ASR) and fractional catabolic rate (FCR) were measured in a subset of 21 men: P (n=5); GH (n=5); T (n=6); GHT (n=5), with an infusion of 1-(13)C leucine. Fat mass (FM) was measured by DEXA and intra-abdominal fat (IAF) by CT scan. RESULTS: IGF-I levels increased in the GH and GHT (P<0.001) groups: testosterone increased in the T (P=0.029) and GHT (P=0.05) groups. There was no change in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein A-I, apolipoprotein B or lipoprotein(a) in the GH, GHT or T groups. In the subset of 21 men, IGF-I levels increased similarly with GH and GHT (P<0.01) but T levels increased only with T (P<0.03). FM and IAF decreased significantly only with GHT (P<0.01, P=0.01). Treatment with GH, T or GHT had no effect on VLDL apoB ASR or VLDL FCR. CONCLUSION: Co-administration of GH and T in near physiological doses in healthy elderly men resulted in favourable changes in body composition without altering the plasma lipid profile or VLDL apoB metabolism.

Aged↗

PubMed2003

Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM): a randomised controlled trial [ISRCTN72884263].

BACKGROUND: Cardiac rehabilitation following myocardial infarction reduces subsequent mortality, but uptake and adherence to rehabilitation programmes remains poor, particularly among women, the elderly and ethnic minority groups. Evidence of the effectiveness of home-based cardiac rehabilitation remains limited. This trial evaluates the effectiveness and cost-effectiveness of home-based compared to hospital-based cardiac rehabilitation. METHODS/DESIGN: A pragmatic randomised controlled trial of home-based compared with hospital-based cardiac rehabilitation in four hospitals serving a multi-ethnic inner city population in the United Kingdom was designed. The home programme is nurse-facilitated, manual-based using the Heart Manual. The hospital programmes offer comprehensive cardiac rehabilitation in an out-patient setting. PATIENTS: We will randomise 650 adult, English or Punjabi-speaking patients of low-medium risk following myocardial infarction, coronary angioplasty or coronary artery bypass graft who have been referred for cardiac rehabilitation. MAIN OUTCOME MEASURES: Serum cholesterol, smoking cessation, blood pressure, Hospital Anxiety and Depression Score, distance walked on Shuttle walk-test measured at 6, 12 and 24 months. Adherence to the programmes will be estimated using patient self-reports of activity.In-depth interviews with non-attendees and non-adherers will ascertain patient views and the acceptability of the programmes and provide insights about non-attendance and aims to generate a theory of attendance at cardiac rehabilitation. The economic analysis will measure National Health Service costs using resource inputs. Patient costs will be established from the qualitative research, in particular how they affect adherence. DISCUSSION: More data are needed on the role of home-based versus hospital-based cardiac rehabilitation for patients following myocardial infarction and revascularisation, which would be provided by the Birmingham Rehabilitation Uptake Maximisation Study (BRUM) study and has implications for the clinical management of these patients. A novel feature of this study is the inclusion of non-English Punjabi speakers.

Cardiology Service, Hospital↗

PubMed2000

Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. QUOROM Group.

BACKGROUND: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). METHODS: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. FINDINGS: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with 'trial flow', study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. INTERPRETATION: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.

Data Collection↗

PubMed2002

The effects of calcium channel blockers on cardiovascular outcomes: a review of randomised controlled trials.

The choice of antihypertensive treatment should be guided by evidence of a reduction in the risk of cardiovascular (CV) events and therefore improved long-term outcome. Using pre-determined criteria, ten randomised, controlled trials that assessed the effects of calcium channel blockers (CCBs) on CV events in patients with hypertension were identified. Six of them enrolled a relatively small number (< 1500) of hypertensive patients, whereas four of the studies were much larger (> 4500 patients). The smaller studies produced mixed findings, especially those trials where CCBs were compared with diuretics; this may reflect methodological limitations and the impact of random error. The results from the four larger studies produced a consistent message: long-acting CCBs such as nifedipine, administered in a gastro-intestinal-transport-system (GITS) formulation, nitrendipine and diltiazem, reduce CV morbidity and mortality in hypertensive patients. In the one study that specifically enrolled high-risk hypertensive patients, nifedipine GITS was as effective as diuretic therapy in reducing CV events, and in all four larger studies sub-group analyses showed that the benefits of these CCBs extend to hypertensive patients with diabetes. The available evidence supports the use of these long-acting CCBs as a first-line treatment option in hypertensive patients.

Calcium Channel Blockers↗

PubMed2007

Steroid injection therapy is the best conservative treatment for lateral epicondylitis: a prospective randomised controlled trial.

The relative merits of a watch and wait policy, physiotherapy alone, steroid injection therapy alone, and physiotherapy and steroid injection therapy combined, for the treatment of tennis elbow, were assessed using a prospective randomised controlled trial (RCT) of factorial design. Although RCTs comparing different treatment strategies for tennis elbow have previously been published, to our knowledge none of the previous studies have combined the modalities of physiotherapy and steroid injection as one of the treatment groups, as we have done in this study. Patients who received steroid injection were statistically significantly better for all outcome measures at follow up. No statistically significant effect of physiotherapy nor interaction between physiotherapy and injection was found. On the basis of the results of this study, the authors advocate steroid injection alone as the first line of treatment for patients presenting with tennis elbow demanding a quick return to daily activities.

Adult↗

PubMed2001

Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care.

OBJECTIVE: To determine whether a decision aid on benign prostatic hypertrophy influences decision making, health outcomes, and resource use. DESIGN: Randomised controlled trial. SETTING: 33 general practices in the United Kingdom. PARTICIPANTS: 112 men with benign prostatic hypertrophy. INTERVENTION: Patients' decision aid consisting of an interactive multimedia programme with booklet and printed summary. OUTCOME MEASURES: Patients' and general practitioners' perceptions of who made the decision, decisional conflict scores, treatment choice and prostatectomy rate, American Urological Association symptom scale, costs, anxiety, utility, and general health status. RESULTS: Both patients and general practitioners found the decision aid acceptable. A higher proportion of patients (32% v 4%; mean difference 28%, 95% confidence interval 14% to 41%) and their general practitioners (46% v 25%; 21%, 3% to 40%) perceived that treatment decisions had been made mainly or only by patients in the intervention group compared with the control group. Patients in the intervention group had significantly lower decisional conflict scores than those in the control group at three months (2.3 v 2.6; -0.3, -0.5 to -0.1, P<0.01) and this was maintained at nine months. No differences were found between the groups for anxiety, general health status, prostatic symptoms, utility, or costs (excluding costs associated with the video disc equipment). CONCLUSIONS: The decision aid reduced decisional conflict in men with benign prostatic hypertrophy, and the patients played a more active part in decision making. Such programmes could be delivered cheaply by the internet, and there are good arguments for coordinated investment in them, particularly for conditions in which patient utilities are important.

Aged↗

PubMed2004

Randomised controlled trial of tetanus treatment with antitetanus immunoglobulin by the intrathecal or intramuscular route.

OBJECTIVE: To evaluate the effect of intrathecal therapy with human antitetanus immunoglobulin on clinical progression of and mortality from tetanus. DESIGN: Randomised controlled trial. SETTING: Intensive care unit of a university hospital, Pernambuco, Brazil. PARTICIPANTS: 120 patients with tetanus allocated to antitetanus immunoglobulin by either the intrathecal and intramuscular route (n = 58) or the intramuscular route (n = 62; control group). MAIN OUTCOME MEASURES: Clinical progression of disease, duration of hospital stay, duration of occurrence of spasms, complications, respiratory infection, respiratory failure or mechanical ventilation, duration of respiratory assistance, and mortality. RESULTS: Patients in the treatment group showed a better clinical progression than those in the control group (chi2 for trend 7.752, P = 0.005; difference in proportion of patients with improvement 20%, 95% confidence interval 4% to 35%). The duration of occurrence of spasms, hospital stay, and respiratory assistance were all shorter in patients the treatment group: respectively, 14.96, 0.0001 (difference in proportion of patients with spasms lasting < or = 10 days 36%, 18% to 55%); 4.56, 0.03; and 6.56, 0.01 (proportion of patients who needed assistance for < or = 10 days 69.2% in the treatment group and 30.8% in the control group (difference 38%, 12% to 65%)). CONCLUSION: Patients treated with antitetanus immunoglobulin by the intrathecal route show better clinical progression than those treated by the intramuscular route.

Adolescent↗

PubMed2004

Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared with hospital.

OBJECTIVES: To compare the efficacy, safety, and acceptability of treatment with intravenous antibiotics for cellulitis at home and in hospital. DESIGN: Prospective randomised controlled trial. SETTING: Christchurch, New Zealand. PARTICIPANTS: 200 patients presenting or referred to the only emergency department in Christchurch who were thought to require intravenous antibiotic treatment for cellulitis and who did not have any contraindications to home care were randomly assigned to receive treatment either at home or in hospital. MAIN OUTCOME MEASURES: Days to no advancement of cellulitis was the primary outcome measure. Days on intravenous and oral antibiotics, days in hospital or in the home care programme, complications, degree of functioning and pain, and satisfaction with site of care were also recorded. RESULTS: The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis, with a mean of 1.50 days (SD 0.11) for the group receiving treatment at home and 1.49 days (SD 0.10) for the group receiving treatment in hospital (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). None of the other outcome measures differed significantly except for patients' satisfaction, which was greater in patients treated at home. CONCLUSIONS: Treatment of cellulitis requiring intravenous antibiotics can be safely delivered at home. Patients prefer home treatment, but in this study only about one third of patients presenting at hospital for intravenous treatment of cellulitis were considered suitable for home treatment.

Adolescent↗

PubMed2005

Effects of locality based community hospital care on independence in older people needing rehabilitation: randomised controlled trial.

OBJECTIVE: To determine the effects on independence in older people needing rehabilitation in a locality based community hospital compared with care on a ward for elderly people in a district general hospital. DESIGN: Randomised controlled trial. SETTING: Care in a community hospital and district general hospital in Bradford, England. PARTICIPANTS: 220 patients needing rehabilitation after an acute illness that required hospital admission. INTERVENTIONS: Patients were randomly allocated to a locality based community hospital or to remain within a department for the care of elderly people in a district general hospital. MAIN OUTCOME MEASURES: Primary outcomes were Nottingham extended activities of daily living scale and general health questionnaire 28 (carer). Secondary outcomes were activities of daily living (Barthel index), Nottingham health profile, hospital anxiety and depression scale, mortality, destination after discharge, satisfaction with services, carer strain index, and carer's satisfaction with services. RESULTS: The median length of stay was 15 days for both the community hospital and the district general hospital groups (interquartile range: community hospital 9-25 days; district general hospital 9-24 days). Independence at six months was greater in the community hospital group (adjusted mean difference 5.30, 95% confidence interval 0.64 to 9.96). Results for the secondary outcome measures, including care satisfaction and measures of carer burden, were similar for both groups. CONCLUSIONS: Care in a locality based community hospital is associated with greater independence for older people than care in wards for elderly people in a district general hospital.

Activities of Daily Living↗

PubMed1999

Randomised controlled trial of effect of terbutaline before elective caesarean section on postnatal respiration and glucose homeostasis.

AIM: To determine if terbutaline given to mothers before elective caesarean section facilitates neonatal respiration and metabolism. METHODS: A randomised controlled trial of 25 full term infants delivered by elective caesarean section was conducted. The mothers received a continuous infusion of terbutaline or saline 120-0 minutes before birth. Umbilical artery blood was collected at birth and analysed for blood gases and catecholamines. The lung function of each infant was assessed two hours after birth, and blood pressure, heart rate, blood glucose and body temperature were monitored until 24 hours of age. RESULTS: The infants of the treated mothers (n = 13) had significantly higher dynamic lung compliance (p < 0.001), lower airway resistance (p < 0.001), and respiratory frequency than control infants (n = 12). Blood glucose and adrenaline concentrations were significantly higher in the treated group (p = 0.0014 and p < 0.01). None of these infants had any clinical respiratory difficulties; there were two cases of transient tachypnoea in the control group. No negative side effects due to the terbutaline treatment were seen among the infants. The mothers felt no discomfort caused by the terbutaline infusion, although they bled more during surgery (p = 0.03). CONCLUSION: Stimulation of the beta adrenoceptors in utero with terbutaline infusion to the mothers promotes neonatal respiratory and metabolic adaptation after elective caesarean section.

Adrenergic beta-Agonists↗

PubMed2002

Randomised controlled trials investigating pharmacological and psychological interventions for treatment-refractory depression. Systematic review.

BACKGROUND: About 30% of people with depression do not respond to an antidepressant at the recommended dose and can be described as having treatment-refractory depression. AIMS: To summarise the findings from all randomised controlled trials (RCTs) that have assessed the efficacy of a pharmacological or psychological intervention for treatment-refractory depression. METHOD: We used a systematic search strategy to identify RCTs that included adults aged 18-75 years with a diagnosis of unipolar depression that had not responded to a 4-week course of a recommended dose of an antidepressant. RESULTS: We identified 16 RCTs. None of the included trials assessed the efficacy of psychotherapy. All the trials were too small to detect an important clinical response. We found only two trials on lithium augmentation, which randomised 50 subjects in total. CONCLUSIONS: There is little evidence to guide the management of depression that has not responded to a course of antidepressants. Treatment-refractory depression is an important public health problem and large pragmatic trials are needed to inform clinical practice.

Antidepressive Agents↗

PubMed2005

A randomised controlled trial to compare the cost-effectiveness of tricyclic antidepressants, selective serotonin reuptake inhibitors and lofepramine.

OBJECTIVE: To determine the relative cost-effectiveness of three classes of antidepressants: tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and the modified TCA lofepramine, as first choice treatments for depression in primary care. DESIGN: Open, pragmatic, controlled trial with three randomised arms and one preference arm. Patients were followed up for 12 months. SETTING: UK primary care: 73 practices in urban and rural areas in England. PARTICIPANTS: Patients with a new episode of depressive illness according to GP diagnosis. INTERVENTIONS: Patients were randomised to receive a TCA (amitriptyline, dothiepin or imipramine), an SSRI (fluoxetine, sertraline or paroxetine) or lofepramine. Patients or GPs were able to choose an alternative treatment if preferred. MAIN OUTCOME MEASURES: At baseline the Clinical Interview Schedule, Revised (CIS-R PROQSY computerised version) was administered to establish symptom profiles. Outcome measures over the 12-month follow-up included the Hospital Anxiety and Depression Scale self-rating of depression (HAD-D), CIS-R, EuroQol (EQ-5D) for quality of life, Short Form (SF-36) for generic health status, and patient and practice records of use of health and social services. The primary effectiveness outcome was the number of depression-free weeks (HAD-D less than 8, with interpolation of intervening values) and the primary cost outcome total direct NHS costs. Quality-adjusted life-years (QALYs) were used as the outcome measure in a secondary analysis. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were computed. Estimates were bootstrapped with 5000 replications. RESULTS: In total, 327 patients were randomised. Follow-up rates were 68% at 3 months and 52% at 1 year. Linear regression analysis revealed no significant differences between groups in number of depression-free weeks when adjusted for baseline HAD-D. A higher proportion of patients randomised to TCAs entered the preference arm than those allocated to the other choices. Switching to another class of antidepressant in the first few weeks of treatment occurred significantly more often in the lofepramine arm and less in the preference arm. There were no significant differences between arms in mean cost per depression-free week. For values placed on an additional QALY of over 5000 pounds, treatment with SSRIs was likely to be the most cost-effective strategy. TCAs were the least likely to be cost-effective as first choice of antidepressant for most values of a depression-free week or QALY respectively, but these differences were relatively modest. CONCLUSIONS: When comparing the different treatment options, no significant differences were found in outcomes or costs within the sample, but when outcomes and costs were analysed together, the resulting cost-effectiveness acceptability curves suggested that SSRIs were likely to be the most cost-effective option, although the probability of this did not rise above 0.6. Choosing lofepramine is likely to lead to a greater proportion of patients switching treatment in the first few weeks. Further research is still needed on the management of depressive illness in primary care. This should address areas such as the optimum severity threshold at which medication should be used; the feasibility and effectiveness of adopting structured depression management programmes in the UK context; the importance of factors such as physical co-morbidity and recent life events in GPs' prescribing decisions; alternative ways of collecting data; and the factors that give rise to many patients being reluctant to accept medication and discontinue treatment early.

Adolescent↗

PubMed2004

New trends in the surgical treatment of outlet obstruction: clinical and functional results of two novel transanal stapled techniques from a randomised controlled trial.

BACKGROUND AND AIMS: A randomised trial was undertaken to compare the clinical and functional results of two novel transanal stapled techniques in patients with outlet obstruction syndrome. MATERIALS AND METHODS: Ninety-six females with outlet obstruction were treated with medical therapy and biofeedback for 2 months; 67 non-responders were evaluated by the Constipation Scoring and Continence Grading Systems, clinical examination, endoscopy, dynamic defecography, anorectal manometry, transanal ultrasound and anal EMG, and 50 of them, all affected with descending perineum, intussusception and rectocele, were randomly assigned to two groups and operated on: 25 patients (mean age 53.2+/-15.3 years) underwent a single Stapled Trans-Anal Prolapsectomy, associated with Perineal Levatorplasty (STAPL Group), and the other 25 (mean 54.6+/-14.2 years) underwent a double Stapled Trans-Anal Rectal Resection (STARR Group). Patients were followed-up for a mean period of 23.4+/-5.1 months in STAPL Group and 22.3+/-4.8 in STARR Group. RESULTS: STARR Group showed a significantly (p<0.0001) lower pattern of postoperative pain and a greater decrease (P=0.0117) of the rectal sensitivity threshold volume; otherwise, no differences were found in operative time, hospital stay, or time of inability to work. Complications included delayed healing of the perineal wound (ten), dyspareunia (five), urinary retention (two) and stenosis (one) in STAPL Group, and urge to defecate (four), transitory incontinence to flatus (two), urinary retention (two), bleeding (one) and stenosis (one) in STARR Group. All constipation symptoms significantly improved without worsening of anal continence and with excellent/good outcome at 20 months in 76 and 88% of patients of STAPL Group and STARR Group, respectively. Seven patients of STAPL Group had a little residual rectocele, while both intussusception and rectocele were corrected in all patients of STARR Group. Neither operation modified anal pressures or caused lesions of anal sphincters. CONCLUSIONS: Both techniques are safe and effective in the treatment of outlet obstruction; nevertheless, the double Stapled Trans-Anal Rectal Resection seems to be preferable due to less pain, absence of dyspareunia, reduced rectal sensitivity threshold volume and absence of residual rectocele at defecography.

Anal Canal↗

PubMedDate not supplied

Ultrasonography in the diagnosis and management of developmental hip dysplasia (UK Hip Trial): clinical and economic results of a multicentre randomised controlled trial.

BACKGROUND: Clinical screening aims to identify and treat neonatal hip instability associated with increased risk of hip displacement, but risks failures of diagnosis and treatment (abduction splinting), iatrogenic effects, and costs to parents and health services. Our objectives were to assess clinical effectiveness and net cost of ultrasonography compared with clinical assessment alone, to provide guidance for management of infants with clinical hip instability. METHODS: Infants with clinical hip instability were recruited from 33 centres in UK and Ireland and randomised to either ultrasonographic hip examination (n=314) or clinical assessment alone (n=315). The primary outcome was appearance on hip radiographs by 2 years. Secondary outcomes included surgical treatment, abduction splinting, level of mobility, resource use, and costs. Analysis was by intention to treat. FINDINGS: Protocol compliance was high, and radiographic information was available for 91% of children by 12-14 months and 85% by 2 years. By age 2 years, subluxation, dislocation, or acetabular dysplasia were identified by radiography on one or both hips of 21 children in each of the groups (relative risk 1.00; 95% CI 0.56-1.80). Fewer children in the ultrasonography group had abduction splinting in the first 2 years than did those in the no-ultrasonography group (0.78; 0.65-0.94; p=0.01). Surgical treatment was required by 21 infants in the ultrasonography group (6.7%) and 25 (7.9%) in the no-ultrasonography group (0.84; 0.48-1.47). One child from the ultrasonography group and four from the no-ultrasonography group were not walking by 2 years (0.25; 0.03-2.53; p=0.37). Infants in the ultrasonography group incurred significantly higher ultrasound costs over the first 2 years (pound 42 vs pound 23, mean difference pound 19, 95% CI 11-27); total hospital costs were lower for those infants, but the difference was not significant. INTERPRETATION: The use of ultrasonography in infants with screen-detected clinical hip instability allows abduction splinting rates to be reduced, and is not associated with an increase in abnormal hip development, higher rates of surgical treatment by 2 years of age, or significantly higher health-service costs.

Costs and Cost Analysis↗

PubMed1998

A randomised controlled trial of intravenous magnesium sulphate versus placebo in the management of women with severe pre-eclampsia.

OBJECTIVE: To determine whether the administration of prophylactic intravenous magnesium sulphate reduces the occurrence of eclampsia in women with severe pre-eclampsia. DESIGN: Randomised controlled trial. SETTING: A tertiary referral obstetric unit. POPULATION: Eight hundred and twenty-two women with severe pre-eclampsia requiring termination of pregnancy by induction of labour or caesarean section. METHODS: The women were randomised to receive either placebo (saline) or magnesium sulphate intravenously. The investigators were blinded to the contents of the pre-mixed solutions. MAIN OUTCOME MEASURE: The occurrence of eclampsia in the two groups. RESULTS: The data of 699 women were evaluated. Fourteen were withdrawn after randomisation. The overall incidence of eclampsia was 1.8%. Of 345 women who received magnesium sulphate, one developed eclampsia (0.3%); in the placebo group, 11/340 women (3.2%) developed eclampsia (relative risk 0.09; 95% confidence interval 0.01-0.69; P = 0.003). CONCLUSION: The use of intravenous magnesium sulphate in the management of women with severe pre-eclampsia significantly reduced the development of eclampsia.

Abortion, Induced↗