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Results for “Randomised controlled trial”

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PubMed2006

Communication training and antibiotic use in acute respiratory tract infections. A cluster randomised controlled trial in general practice.

UNLABELLED: A cluster-randomised controlled trial in general practice BACKGROUND: Physician-patient communication plays a key role in treatment decisions in primary care. We aimed to reduce the antibiotic prescription rate for acute respiratory tract infections using a short training programme in patient-centred communication. METHODS: We conducted a cluster-randomised controlled trial in 45 general practices in Switzerland. Thirty physicians received evidence-based guidelines for the management of acute respiratory tract infections; 15 physicians randomised to the full intervention additionally received training in patient-centred communication. A further 15 physicians, not randomised, served as a control to blind the physicians in the other two groups to the true comparison. The primary outcome was the antibiotic prescription rate reported by pharmacists. Secondary outcomes were patient satisfaction and enablement, re-consultation rates, days with restrictions, and days off work. 1108 adults with acute respiratory infections were screened between January and May 2004. Outcomes were measured in 837 consultations; 624 patients had follow-up interviews at 7 and 14 days. RESULTS: The antibiotic prescription rate reported by pharmacists was low in both full and limited intervention groups (13.5% and 15.7% respectively) but only half of the antibiotics were prescribed according to guidelines (53.8% and 53.1%). No significant differences were seen between the two randomised groups in primary and secondary outcomes. In both groups patient satisfaction was high (median score for both 68 out of 70). CONCLUSIONS: In this trial, patient-centred communication training did not reduce the rate of antibiotic prescriptions below an already unusually low level. Even with this low prescription rate, patient satisfaction with received care was high.

Adult↗

PubMed2000

Does evidence-based medicine exist in the treatment of Menière's disease? A critical review of the last decade of publications.

Debate surrounding the need for evidence-based research in all fields of otolaryngology has recently emerged. A review of English language articles dealing with the treatment of Menière's disease published from 1989 to 1999 was performed. The papers were classified according to article type (observational studies, non-clinical studies, controlled trials, randomised controlled trials) and according to the grade of evidence that was offered. A total of 128 publications were reviewed, of which only three were randomised controlled trials and a further three were well-designed controlled studies without randomization. The majority of papers were non-experimental clinical descriptive studies or case series. Data from this review would suggest that more comprehensive evidence-based studies are required in order to settle areas of confusion surrounding treatment of this relapsing condition

Clinical Trials as Topic↗

PubMed2001

The CRASH trial: the first large-scale, randomised, controlled trial in head injury.

The global epidemic of head injuries is just beginning. Many are caused by road traffic crashes. It is estimated that, by 2020, road traffic crashes will have moved from its present position of ninth to third in the world disease burden ranking, as measured in disability adjusted life years. In developing countries, it will have moved to second. The Corticosteroid Randomisation After Significant Head Injury (CRASH) trial is a large-scale, randomised, controlled trial, among adults with head injury and impaired consciousness, of the effects of a short-term infusion of corticosteroids on death and on neurological disability. Following a successful pilot phase, which included over 1000 randomised participants, the main phase of the trial is now underway. Over the next 5 years, the trial aims to recruit a total of 20,000 patients. Such large numbers will only be possible if hundreds of doctors and nurses can collaborate in emergency departments all over the world. The trial is currently recruiting, and new collaborators are welcome to join the trial (see www.crash.lshtm.ac.uk).

Accidents, Traffic↗

PubMed2005

Role of glycopeptides as part of initial empirical treatment of febrile neutropenic patients: a meta-analysis of randomised controlled trials.

We did a meta-analysis of randomised controlled trials studying glycopeptides as part of the initial empirical treatment of febrile neutropenic patients with a beta-lactam and with or without an aminoglycoside. 14 randomised controlled trials that studied 2413 patients were included in the analysis. A better outcome regarding treatment success, without modification of the initial regimen, was accomplished with the inclusion of a glycopeptide in the empirical therapy; this better outcome applied to the full set of studied patients (OR=1.63, 95% CI 1.17-2.28), as well as in three important subsets of patients--those with microbiologically documented infections (2.03, 1.39-2.97), patients with bacteraemia (1.80, 1.23-2.63), and patients with severe neutropenia, defined as a white blood cell count below 100 cells/microL (2.24, 1.15-4.39). However, mortality was not different in the compared groups (0.67, 0.42-1.05). Overall treatment success was not different if a glycopeptide was added to the antimicrobial regimen in the case of continuation of fever 72 hours or more after the start of treatment (1.02, 0.68-1.52). Also, the inclusion of a glycopeptide in the empirical regimen did not lead to a difference regarding time to defervesence. Adverse effects (4.98, 2.91-8.55), including nephrotoxicity (2.10, 1.12-3.95), were more common in the group receiving a glycopeptide as part of the empirical treatment. In conclusion, our meta-analysis suggests that there are good reasons why glycopeptides should not be routinely used as part of the initial empirical treatment of febrile neutropenic patients.

Anti-Bacterial Agents↗

PubMed2003

Superficial dry needling and active stretching in the treatment of myofascial pain--a randomised controlled trial.

UNLABELLED: A pragmatic, single blind, randomised, controlled trial was conducted to test the hypothesis that superficial dry needling (SDN) together with active stretching is more effective than stretching alone, or no treatment, in deactivating trigger points (TrPs) and reducing myofascial pain. Forty patients with musculoskeletal pain, referred by GPs for physiotherapy, fulfilled inclusion/ exclusion criteria for active TrPs. Subjects were randomised into three groups: group 1(n = 14) received superficial dry needling (SDN) and active stretching exercises (G1); group 2 (n = 13) received stretching exercises alone (G2); and group 3 (n = 13) were no treatment controls (G3). During the three-week intervention period for G1 and G2, the number of treatments varied according to the severity of the condition and subject/clinician availability. Assessment was carried out pre-intervention (M1, post-intervention (M2), and at a three-week follow up (M3). Outcome measures were the Short Form McGill Pain Questionnaire (SFMPQ) and Pressure Pain Threshold (PPT) of the primary TrP, using a Fischer algometer. Ninety-one per cent of assessments were blind to grouping. At M2 there were no significant inter-group differences, but at M3, G1 demonstrated significantly improved SFMPQ versus G3 (p = 0 .043) and significantly improved PPT versus G2 (p = 0 .011). There were no differences between G2 and G3. The mean PPT and SFMPQ scores correlated significantly in G1 only, though no significant inter-group differences were demonstrated. Numbers of patients requiring further treatment following the trial were: 6 (G1); 12 (G2); 9 (G3). CONCLUSION: SDN followed by active stretching is more effective than stretching alone in deactivating TrPs (reducing their sensitivity to pressure), and more effective than no treatment in reducing subjective pain. Stretching without prior deactivation may increase TrP sensitivity.

Acupuncture Analgesia↗

PubMed2004

Is acarbose equivalent to tolbutamide as first treatment for newly diagnosed type 2 diabetes in general practice? A randomised controlled trial.

We performed a double blind randomised controlled trial in general practice to assess equivalence between tolbutamide and acarbose with respect to the effect on mean HbA(1c) in newly diagnosed patients with type 2 diabetes. Secondary objectives were to compare the effects of both treatments on fasting and post-load blood glucose and insulin levels, lipids, and adverse events. Patients were randomised to receive acarbose, titrated step-wise to a maximum of 100mg three times daily (n=48) or tolbutamide, similarly titrated to a maximum of 2000 mg in three doses (n=48). The two treatments were considered equivalent if the two-sided 90% confidence interval (CI) for the difference in mean HbA(1c) levels was within the range -0.4 to 0.4%. Results were analysed on an intention-to-treat, per-protocol and on worst-case basis. Both agents reduced the HbA(1c) percentage and fasting blood glucose levels. The difference in mean decrease of HbA(1c) was 0.6% in favour of tolbutamide (90% CI 0.3, 0.9; 95% CI 0.2, 1.0). A worst-case analysis, assuming no change in HbA(1c) for dropouts, yielded a difference in mean decrease of 0.9% (90% CI 0.6, 1.2) in favour of tolbutamide. The difference in mean decrease of fasting blood glucose was 1.0 mmol/l in favour of tolbutamide (95% CI 0.3, 1.7). There were no significant differences in post-load blood glucose, fasting and post-load insulin levels, or lipids. In the acarbose group significantly more patients (15 versus 3) discontinued therapy because of adverse effects, mostly of gastrointestinal origin. We conclude that the results of this study favour tolbutamide over acarbose as first treatment for patients with newly diagnosed type 2 diabetes.

Acarbose↗

PubMed2006

Increasing participation of cancer patients in randomised controlled trials: a systematic review.

BACKGROUND: There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs) of cancer treatments. METHODS: A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted. RESULTS: Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work. CONCLUSION: There is not a strong evidence-base for interventions that increase cancer patient participation in randomised trials. Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials.

Journal Article↗

PubMed2005

Controversial choice of a control intervention in a trial of ventilator therapy in ARDS: standard of care arguments in a randomised controlled trial.

When evaluating an innovative intervention in a randomised controlled trial (RCT), choosing an appropriate control intervention is necessary for a clinically meaningful result. An RCT reported in 2000 addressed the relative merits of two tidal volume ventilatory strategies, 6 ml/kg (innovative) and 12 ml/kg (control), in patients with acute respiratory distress syndrome. Critics claim that the 12 ml/kg volume did not represent the clinical practice standard at that time, and that lower tidal volumes had been used in some patients prior to randomisation. The trialists responded that current practice involved the use of a broad range of tidal volumes, including 12 ml/kg. Appropriate control interventions for RCTs can be ensured by: a systematic review of the relevant literature; a formal survey of expert clinicians; and publication of the proposed research protocol to solicit critical appraisal. A global survey of experts during the RCT's design stage would have been of probative value in determining the appropriate control tidal volume. Hypothetical, but plausible, results of such a survey are presented and examined to demonstrate the value of this method.

Choice Behavior↗

PubMed1998

The practice of antenatal care: comparing four study sites in different parts of the world participating in the WHO Antenatal Care Randomised Controlled Trial.

In the preparation of a randomised controlled trial to evaluate a new programme of antenatal care (ANC) in different parts of the world, we conducted a baseline survey of the ANC procedures in all 53 clinics participating in the trial. There were two components of this survey: (1) description of clinic characteristics and services offered: the staff of each clinic was interviewed and direct observation was made by field supervisors, and (2) the actual use of services by pregnant women attending these clinics: we reviewed a random sample of 2913 clinical histories. The clinical units surveyed were offering most of the activities, screening, laboratory tests and interventions recommended as effective according to the Cochrane Pregnancy and Childbirth Database (PCD), although some of these were not available in some sites. On the other hand, some tests and interventions that are considered not effective according to these criteria are reportedly offered. There was a difference across sites in the availability and offer to low-risk women of vaginal examination, evaluation of pelvic size, dental examination, external version for breech presentation and formal risk score classification, and a notable difference in the type of principal provider of ANC. There was a large variation in the actual use of screening and laboratory tests and interventions that should be offered to all women according to Cochrane PCD criteria: some of these are simply not available in a site; others are available, but only a fraction of women attending the clinics are receiving them. The participating sites all purport to follow the traditional 'Western' schedule for ANC, but in three sites we found that a high percentage of women initiate their ANC after the first trimester, and therefore do not have either the recommended minimum number of visits during pregnancy or the minimum first trimester evaluation. It is concluded that the variability and heterogeneity of ANC services provided in the four study sites are disturbing to the profession and cast doubts on the rationale of routine ANC.

Argentina↗

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↗

PubMed2006

ALIFE@Work: a randomised controlled trial of a distance counselling lifestyle programme for weight control among an overweight working population [ISRCTN04265725].

BACKGROUND: The prevalence of overweight is increasing and its consequences will cause a major public health burden in the near future. Cost-effective interventions for weight control among the general population are therefore needed. The ALIFE@Work study is investigating a novel lifestyle intervention, aimed at the working population, with individual counselling through either phone or e-mail. This article describes the design of the study and the participant flow up to and including randomisation. METHODS/DESIGN: ALIFE@Work is a controlled trial, with randomisation to three arms: a control group, a phone based intervention group and an internet based intervention group. The intervention takes six months and is based on a cognitive behavioural approach, addressing physical activity and diet. It consists of 10 lessons with feedback from a personal counsellor, either by phone or e-mail, between each lesson. Lessons contain educational content combined with behaviour change strategies. Assignments in each lesson teach the participant to apply these strategies to every day life. The study population consists of employees from seven Dutch companies. The most important inclusion criteria are having a body mass index (BMI) > or = 25 kg/m2 and being an employed adult. Primary outcomes of the study are body weight and BMI, diet and physical activity. Other outcomes are: perceived health; empowerment; stage of change and self-efficacy concerning weight control, physical activity and eating habits; work performance/productivity; waist circumference, sum of skin folds, blood pressure, total blood cholesterol level and aerobic fitness. A cost-utility- and a cost-effectiveness analysis will be performed as well. Physiological outcomes are measured at baseline and after six and 24 months. Other outcomes are measured by questionnaire at baseline and after six, 12, 18 and 24 months. Statistical analyses for short term (six month) results are performed with multiple linear regression. Analyses for long term (two year) results are performed with multiple longitudinal regression. Analyses for cost-effectiveness and cost-utility are done at one and two years, using bootstrapping techniques. DISCUSSION: ALIFE@Work will make a substantial contribution to the development of cost-effective weight control- and lifestyle interventions that are applicable to and attractive for the large population at risk.

Adult↗

PubMed2004

Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials.

The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality.

Adult↗

PubMed2005

Drug eluting stents: an updated meta-analysis of randomised controlled trials.

OBJECTIVE: To confirm the overall benefit of drug eluting stents (DES), to evaluate the effect of different DES, and to assess the global safety of DES compared with bare stents through a meta-analysis of randomised controlled trials. METHODS: Randomised controlled trials comparing sirolimus and derivates or paclitaxel and derivates eluting stents versus bare stents. Binary restenosis and major adverse cardiac events (MACE) were chosen as primary end points. Death, Q wave myocardial infarction (MI), and stent thrombosis up to 12 months' follow up were also analysed. RESULTS: MACE overall occurrence was highly reduced with DES from 19.9% to 10.1% (odds ratio (OR) 0.46, 95% confidence interval (CI) 0.41 to 0.52, p < 0.001). A significant heterogeneity (p < 0.001) was found between subgroups according to the drug: MACE OR was 0.28 (95% CI 0.22 to 0.35) in the sirolimus subgroup and 0.62 (95% CI 0.53 to 0.73) in the paclitaxel subgroup. Restenosis was also highly reduced from 31.7% with bare stents to 10.5% with DES (OR 0.25, 95% CI 0.22 to 0.29, p < 0.001) with a similar heterogeneity between subgroups. Mortality, Q wave MI, and stent thrombosis were not significantly different between DES and control group, whereas Q wave MI and stent thrombosis tended to be more frequent with paclitaxel. CONCLUSION: This meta-analysis confirms the overall benefit of DES on restenosis and MACE with significant heterogeneity between drugs, suggesting higher efficacy of sirolimus eluting stents. Additional data with longer follow up and in high risk populations are needed to clarify issues on stent thrombosis.

Blood Vessel Prosthesis↗

PubMed2006

Continuous interscalene infusion and single injection using levobupivacaine for analgesia after surgery of the shoulder. A double-blind, randomised controlled trial.

We performed a double-blind, randomised controlled trial to assess the effectiveness of a continuous-infusion brachial plexus block with levobupivacaine compared with that of a standard single injection for the management of post-operative pain after surgery on the shoulder. Eight patients were randomised to receive a pre-operative brachial plexus block using 30 ml of levobupivacaine 0.5% with adrenaline 1:200 000 followed by insertion of a 20-gauge polyamide catheter. This was connected to a disposable elastometric pump, set immediately after surgery to administer a continuous flow of levobupivacaine 0.25% at a rate of 5 ml per hour. The other eight patients were randomised to receive only the initial injection of 30 ml. The study was double-blinded with the aid of sham catheters and clamped pumps. All patients were given regular paracetamol and were prescribed morphine through a patient-controlled analgesia pump. Motor and sensory block assessments, visual analogue scale pain scores and consumption of morphine were recorded after the operation and then at 6, 12 and 24 hours after administration of the block. Satisfactory motor and sensory block was achieved in all patients. The mean visual analogue scale pain score at 12 hours and consumption of morphine at 24 hours after injection were significantly lower (p < 0.05) in the continuous-infusion group. This group also took longer to request their first additional analgesia and reported a significantly higher overall level of satisfaction. Our study has shown that continuous interscalene infusion of levobupivacaine is an effective method of post-operative analgesia after major surgery of the shoulder.

Adult↗

PubMed1997

The Internet and randomised controlled trials.

Several factors constrain the implementation of Randomised Controlled Trials (RCTs). To obtain large sample sizes a multicentred multinational trial may be necessary or a long sampling period. The larger the trial the larger is the unit cost. To allow larger sample sizes, shorter sampling periods and lower unit costs, new methods are needed. The Internet and in particular the WWW provides such an opportunity. The WWW can provide global access, fast interaction and automation. A prototype Internet Trials Service (ITS) is currently being tested with a real international clinical trial (the Growth Restriction Intervention Trial--GRIT). The ITS is hosted on a Web server. It provides a series of HTML documents that describe the GRIT protocol. Registered centres may enter patients into the GRIT trial via ITS. Java applets are used to collect trial data before returning the study number and randomisation. ITS assumes all trial data will be intercepted by a sniffer. Therefore no information is sent that could specifically identify a patient, this must be sent later by more secure means. ITS assumes that trial centres can be spoofed. To authenticate the patients entered into the trial and the trial data sent, a regular audit report is sent to each centre by secure means for confirmation. By using Java, a full functional data entry system can be developed that runs locally within any Java enabled browser. It can perform data validation locally and also provide a sophisticated user interface.

Child Development↗

PubMed2002

Factors affecting general practitioner involvement in a randomised controlled trial in primary care.

AIMS: To investigate factors associated with patient recruitment by general practitioners (GPs) in a randomised controlled trial in primary care. METHODS: Cross sectional survey of 100 GPs who had agreed to recruit patients for a randomised controlled trial. A postal questionnaire was sent to the 100 GPs to collect information on factors associated with recruitment in the randomised controlled trial. RESULTS: The response rate to the survey was 97%. GPs who reported that practice nurses were involved in the research project were significantly more likely to recruit patients into the trial. Age, sex, membership of an independent practitioner association (IPA), number of half days worked, and the number of GPs working in a practice were not associated with recruitment. CONCLUSIONS: Involvement of practice nurses together with GPs may improve recruitment of patients in randomised controlled trials in primary care in New Zealand.

Adult↗

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↗

PubMed2005

Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial.

AIM: This study is a prospective randomised controlled trial comparing sapheno-femoral ligation, great saphenous stripping and multiple avulsions with sapheno-femoral ligation and ultrasound guided foam sclerotherapy to the saphenous vein. Primary end points were patient recovery period and quality of life and secondary end points frequency of complications on the two arms of the trial and the cost of the treatment. MATERIAL AND METHOD: Sixty patients with primary varicose veins due to GSV incompetence and suitable for day case surgery were randomly allocated to undergo ultrasound-guided sclerotherapy with sapheno-femoral ligation under local anaesthesia (n=30) or sapheno-femoral ligation, stripping and multiple avulsions under general anaesthesia (n=30). The study protocol included history, physical examination, assignment of CEAP class and assessment venous clinical severity score (VCSS), completion of the aberdeen vein questionnaire (AVQ) and colour duplex ultrasound. RESULTS: All treatments were completed as intended. Median time to return to normal activities was significantly reduced in the foam sclerotherapy group (2 days) compared to the surgical group (8 days) (p<0.001, Mann-Whitney). AVQ score was also significantly reduced at 3 months by 46% in the sclerotherapy group, and by 40% in the conventional surgery group (p<0.001, Wilcoxon). The time taken to complete treatment was shorter in the foam sclerotherapy plus SFJ ligation group: 45 vs. 85 min (p<0.001, Mann-Whitney). The overall cost of the procedure in the sclerotherapy group ( 672.97 pounds) was significantly less compared to conventional surgery ( 1120.64 pounds). At 3 weeks, there was no statistical difference in the complication rate between the two groups. At 3 months, median CEAP class dropped from four pre-operatively to one following treatment in both groups and the median VCSS score dropped from five to one in group one and from seven to three in group two (p<0.001, Wilcoxon test). In group one four patients (13%) had a recanalised vein which needed further sessions of foam sclerotherapy, resulting in a short-term closure rate of 87%. CONCLUSION: Ultrasound guided sclerotherapy combined with sapheno-femoral ligation was less expensive, involved a shorter treatment time and resulted in more rapid recovery compared to sapheno-femoral ligation, saphenous stripping and phlebectomies.

Adult↗