Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial.
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ABSTRACT: Objective
To determine the effectiveness of early physiotherapy in reducing the risk of secondary lymphoedema after surgery for breast cancer.Design
Randomised, single blinded, clinical trial.Setting
University hospital in Alcalá de Henares, Madrid, Spain.Participants
120 women who had breast surgery involving dissection of axillary lymph nodes between May 2005 and June 2007.Intervention
The early physiotherapy group was treated by a physiotherapist with a physiotherapy programme including manual lymph drainage, massage of scar tissue, and progressive active and action assisted shoulder exercises. This group also received an educational strategy. The control group received the educational strategy only.Main outcome measure
Incidence of clinically significant secondary lymphoedema (>2 cm increase in arm circumference measured at two adjacent points compared with the non-affected arm).Results
116 women completed the one year follow-up. Of these, 18 developed secondary lymphoedema (16%): 14 in the control group (25%) and four in the intervention group (7%). The difference was significant (P=0.01); risk ratio 0.28 (95% confidence interval 0.10 to 0.79). A survival analysis showed a significant difference, with secondary lymphoedema being diagnosed four times earlier in the control group than in the intervention group (intervention/control, hazard ratio 0.26, 95% confidence interval 0.09 to 0.79).Conclusion
Early physiotherapy could be an effective intervention in the prevention of secondary lymphoedema in women for at least one year after surgery for breast cancer involving dissection of axillary lymph nodes.Trial registration
Current controlled trials ISRCTN95870846.
SUBMITTER: Torres Lacomba M
PROVIDER: S-EPMC2806631 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVE:To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery. DESIGN:Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial. SETTING:Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand. PARTICIPANTS:441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial. INTERVENTIONS:Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided. MAIN OUTCOME MEASURES:The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months. RESULTS:The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected. CONCLUSION:In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.
| S-EPMC5782401 | biostudies-literature
Project description:BackgroundPodoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia.MethodsWe did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210.FindingsBetween Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9-19·9) in the intervention group and 23·9 episodes per person-year (23·4-24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of -4·5 (-5·1 to -3·8) episodes per person-year. No serious adverse events related to the intervention were reported.InterpretationA simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries.FundingJoint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).
| S-EPMC6562300 | biostudies-literature
Project description:BACKGROUND:Regional anaesthesia for upper limb surgery is routinely performed with brachial plexus blocks. A retroclavicular brachial plexus block has recently been described, but has not been adequately compared with another approach. This randomised controlled single-blinded trial tested the hypothesis that the retroclavicular approach, when compared with the supraclavicular approach, would increase the success rate. METHODS:One hundred and twenty ASA physical status 1-3 patients undergoing distal upper limb surgery were randomised to receive an ultrasound-guided retroclavicular or supraclavicular brachial plexus block with 30 mL of a 1:1 mixture of mepivacaine 1% and ropivacaine 0.5%, using a single-injection technique without needle tip repositioning. The primary outcome was block success rate 30 min after local anaesthetic injection, defined as a composite score of 14 of 16 points, inclusive of sensory and motor components. Secondary outcomes included needling time, time to first opioid request, oxycodone consumption, and pain scores (numeric rating scale, 0-10) at 24 h postoperatively. RESULTS:Success rates were 98.3% [95% confidence interval (CI): 90.8%, 99.9%] and 98.3% [95% CI: 90.9%, 99.9%] in the supraclavicular and retroclavicular groups, respectively (P=0.99). The mean needling time was reduced in the supraclavicular group [supraclavicular: 5.0 (95% CI: 4.7, 5.4) min; retroclavicular: 6.0 (95% CI: 5.4, 6.6) min; P=0.006]. The mean time to first opioid request was similar between groups [supraclavicular: 439 (95% CI: 399, 479) min; retroclavicular: 447 (95% CI: 397, 498) min; P=0.19] as were oxycodone consumption [supraclavicular: 10.0 (95% CI: 6.5, 13.5 mg; retroclavicular: 7.9 (95% CI: 4.8, 11.0) mg; P=0.80] and pain scores at 24 h postoperatively [supraclavicular: 1.2 (95% CI: 2.1, 2.7); retroclavicular: 1.5 (95% CI: 1.6, 2.4); P=0.09]. CONCLUSIONS:Ultrasound-guided retroclavicular and supraclavicular brachial plexus blocks share identical success rates, while providing similar pain relief. Reduced needling time in the supraclavicular approach is not clinically relevant. CLINICAL TRIAL REGISTRATION:NCT02641613.
| S-EPMC6435841 | biostudies-literature
Project description:BackgroundWe investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer.MethodsPatients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T-MLD) received treatment 2×weekly for 4 weeks. The primary outcome was the volume reduction (%) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status.ResultsDespite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T-MLD) completed the trial. In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0% [95% CI, -4.3;2.3%]): the precision in the 95% confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were -6.8%(1.2) and -5.7% (1.2) in the T+MLD and T-MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis.ConclusionManual lymphatic drainage adds no further volume reduction in breast cancer patients.
| S-EPMC6251025 | biostudies-literature
Project description:The aim of our study was to compare, in terms of aesthetic results, the use of synthetic glue to intradermal absorbable sutures in postthyroidectomy and parathyroidectomy wound closure in a single blinded, randomised, per protocol equivalence study. From September 2008 to May 2010, patients undergoing thyroid or parathyroid surgery (with an external approach) at the Otolaryngology Department of the University Hospital of Modena were assessed for eligibility. In total, 42 patients who had had synthetic glue application on surgical incisions (A) and 47 patients who had subcuticular sutures on their surgical incisions (B) were enrolled. The mean of the endpoint (based on the Wound Registry Scale) of group A at 10 days was 1.4, while that in group B (based on the Stony Brook Scar Evaluation Scale) was 2.9. Statistically significant (p = 0.002) and clinically significant (difference of the means = 1.5) differences in the aesthetic results were found between groups A and B at 10 days, with better results in group B. On the other hand, at 3 months, the mean of the endpoint in group A was 3.1 while that in group B was 2.8; no statistically significant (p = 0.62) or clinically significant (difference in means = 0.3) differences were found between groups A and B. In conclusion, synthetic glue differs from subcuticular suture in post-thyroidectomy or post-parathyroidectomy incision for early aesthetic results, with better outcomes for subcuticular sutures. At 3 months, there were no differences in aesthetic outcomes between groups. Moreover, sex, incision length, age, cold/hot blade and correspondence of the incision with a wrinkle in the skin did not seem to influence aesthetic outcomes with this type of incision.
| S-EPMC4347000 | biostudies-literature
Project description:BackgroundPerioperative fluid restriction in a variety of operations has shown improvement of: complications, recovery of gastrointestinal function and length of stay (LOS). We investigated effects of crystalloid fluid restriction in pancreatic surgery. Our hypothesis: enhanced recovery of gastrointestinal function.MethodsIn this double-blinded randomized trial, patients scheduled to undergo pancreatoduodenectomy (PD) were randomized: standard (S:10ml/kg/hr) or restricted (R:5ml/kg/hr) fluid protocols.Primary endpointgastric emptying scintigraphically assessed on postoperative day 7.ResultsIn 66 randomized patients, complications and 6-year survival were analyzed. 54 patients were analyzed in intention to treat: 24 S-group and 30 R-group. 32 patients actually underwent a PD and 16 patients had a palliative gastrojejunostomy bypass operation in the full protocol analysis. The median gastric emptying time (T½) was 104 minutes (S-group, 95% confidence interval: 74-369) versus 159 minutes (R-group, 95% confidence interval: 61-204) (P = 0.893, NS). Delayed gastric emptying occurred in 10 patients in the S-group and in 13 patients in the R-group (45% and 50%, P = 0.779, NS). The primary outcome parameter, gastric emptying time, did not show a statistically significant difference between groups.ConclusionA fluid regimen of 10ml/kg/hr or 5ml/kg/hr during pancreatic surgery did not lead to statistically significant differences in gastric emptying. A larger study would be needed to draw definite conclusions about fluid restriction in pancreatic surgery.Trial registrationISRCTN62621488.
| S-EPMC4605599 | biostudies-literature
Project description:Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness.This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated.We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease.ClinicalTrials.gov identifier: NCT01547611.
| S-EPMC3923245 | biostudies-literature
Project description:Background:Patellar instability is a relatively common condition that leads to disability and restriction of activities. People with recurrent instability may be given the option of physiotherapy or surgery though this is largely driven by clinician preference rather than by a strong evidence base. We sought to determine the feasibility of conducting a definitive trial comparing physiotherapy with surgical treatment for people with recurrent patellar instability. Methods:This was a pragmatic, open-label, two-arm feasibility randomised control trial (RCT) with an embedded interview component recruiting across three NHS sites comparing surgical treatment to a package of best conservative care; 'Personalised Knee Therapy' (PKT). The primary feasibility outcome was the recruitment rate per centre (expected rate 1 to 1.5 participants recruited each month). Secondary outcomes included the rate of follow-up (over 80% expected at 12 months) and a series of participant-reported outcomes taken at 3, 6 and 12 months following randomisation, including the Norwich Patellar Instability Score (NPIS), the Kujala Patellofemoral Disorder Score (KPDS), EuroQol-5D-5L, self-reported global assessment of change, satisfaction at each time point and resources use. Results:We recruited 19 participants. Of these, 18 participants (95%) were followed-up at 12 months and 1 (5%) withdrew. One centre recruited at just over one case per month, one centre was unable to recruit, and one centre recruited at over one case per month after a change in participant screening approach. Ten participants were allocated into the PKT arm, with nine to the surgical arm. Mean Norwich Patellar Instability Score improved from 40.6 (standard deviation 22.1) to 28.2 (SD 25.4) from baseline to 12 months. Conclusion:This feasibility trial identified a number of challenges and required a series of changes to ensure adequate recruitment and follow-up. These changes helped achieve a sufficient recruitment and follow-up rate. The revised trial design is feasible to be conducted as a definitive trial to answer this important clinical question for people with chronic patellar instability. Trial registration:The trial was prospectively registered on the International Standard Randomised Controlled Trial Number registry on the 22/12/2016 (reference number: ISRCTN14950321). http://www.isrctn.com/ISRCTN14950321.
| S-EPMC7336411 | biostudies-literature
Project description:ObjectiveWomen with pre-eclampsia have elevated circulating levels of soluble fms-like tyrosine kinase-1 (sFlt-1). Statins can reduce sFlt-1 from cultured cells and improve pregnancy outcome in animals with a pre-eclampsia-like syndrome. We investigated the effect of pravastatin on plasma sFlt-1 levels during pre-eclampsia.DesignBlinded (clinician and participant), proof of principle, placebo-controlled trial.SettingFifteen UK maternity units.PopulationWe used a minimisation algorithm to assign 62 women with early-onset pre-eclampsia (24+0 -31+6 weeks of gestation) to receive pravastatin 40 mg daily (n = 30) or matched placebo (n = 32), from randomisation to childbirth.Primary outcomeDifference in mean plasma sFlt-1 levels over the first 3 days following randomisation.ResultsThe difference in the mean maternal plasma sFlt-1 levels over the first 3 days after randomisation between the pravastatin (n = 27) and placebo (n = 29) groups was 292 pg/ml (95% CI -1175 to 592; P = 0.5), and over days 1-14 was 48 pg/ml (95% CI -1009 to 913; P = 0.9). Women who received pravastatin had a similar length of pregnancy following randomisation compared with those who received placebo (hazard ratio 0.84; 95% CI 0.50-1.40; P = 0.6). The median time from randomisation to childbirth was 9 days (interquartile range [IQR] 5-14 days) for the pravastatin group and 7 days (IQR 4-11 days) for the placebo group. There were three perinatal deaths in the placebo-treated group and no deaths or serious adverse events attributable to pravastatin.ConclusionsWe found no evidence that pravastatin lowered maternal plasma sFlt-1 levels once early-onset pre-eclampsia had developed. Pravastatin appears to have no adverse perinatal effects.Tweetable abstractPravastatin does not improve maternal plasma sFlt-1 or placental growth factor levels following a diagnosis of early preterm pre-eclampsia #clinicaltrial finds.
| S-EPMC7063986 | biostudies-literature
Project description:Background and Objectives: Patients undergoing cardiac surgery are particularly vulnerable for developing postoperative pulmonary complications (PPCs). This systematic review and meta-analysis aimed to evaluate the role of preoperative chest physiotherapy in such patients. Materials and Methods: All original articles that assessed patients undergoing elective cardiac surgery, with preoperative chest physiotherapy, and compared them to patients undergoing elective cardiac surgery, without preoperative chest physiotherapy, were included. Animal studies, studies conducted prior to the year 2000, commentaries, or general discussion papers whose authors did not present original data were excluded. Studies assessing physiotherapy regimens other than chest physiotherapy were also excluded. The search was performed using the following electronic resources: the Cochrane Central Register of Controlled Trials, the PubMed central database, and Embase. The included studies were assessed for potential bias using the Cochrane Collaboration's tool for assessing the risk of bias. Each article was read carefully, and any relevant data were extracted. The extracted data were registered, tabulated, and analyzed using Review Manager software. Results: A total of 10 articles investigating 1458 patients were included in the study. The studies were published from 2006 to 2019. The populations were patients scheduled for elective CABG/cardiac surgery, and they were classified into two groups: the interventional (I) group, involving 651 patients, and the control (C) group, involving 807 patients. The meta-analysis demonstrated no significant differences between the interventional and control groups in surgery time and ICU duration, but a significant difference was found in the time of mechanical ventilation and the length of hospital stay, favoring the interventional group. A significant difference was shown in the forced expiratory volume in 1s (FEV1% predicted), forced vital capacity (FVC% predicted), and maximum inspiratory pressure (Pi-max), favoring the interventional group. Conclusions: This study is limited by the fact that one of the included ten studies was not an RCT. Moreover, due to lack of the assessment of certain variables in some studies, the highest number of studies included in a meta-analysis was the hospital stay length (eight studies), and the other variables were analyzed in a fewer number of studies. The data obtained can be considered as initial results until more inclusive RCTs are conducted involving a larger meta-analysis. However, in the present study, the intervention was proved to be protective against the occurrence of PPCs. The current work concluded that preoperative chest physiotherapy can yield better outcomes in patients undergoing elective cardiac surgery.
| S-EPMC9319848 | biostudies-literature