Effect of pneumatic leg compression on post-induction hypotension in elderly patients undergoing robot-assisted laparoscopic prostatectomy: a double-blind randomised controlled trial

Post-induction hypotension is common and associated with postoperative complications. We hypothesised that pneumatic leg compression reduces post-induction hypotension in elderly patients undergoing robot-assisted laparoscopic prostatectomy. In this double-blind randomised study, patients were allocated randomly to the pneumatic leg compression group (n = 50) or control (n = 50). In the intervention group, pneumatic leg compression was initiated before induction of anaesthesia. In the control group, pneumatic leg compression was initiated 20 min after anaesthesia induction. The primary outcome was the incidence of post-induction hypotension in these groups. Post-induction hypotension was defined as systolic blood pressure < 90 mmHg during the first 20 min after induction. Haemodynamic variables and area under the curve of post-induction systolic blood pressure over time were assessed. Complications associated with pneumatic leg compression were recorded, including: peripheral neuropathy; compartment syndrome; extensive bullae beneath the leg sleeves; and pulmonary thromboembolism. The incidence of post-induction hypotension decreased in the pneumatic leg compression group compared with that in the control group; 5 (10%) vs. 29 (58%), respectively, p < 0.001. In the pneumatic leg compression group, the lowest systolic, diastolic and mean blood pressures 20 min after induction of anaesthesia were significantly greater than the control group. Pneumatic leg compression resulted in an increased area under the curve of systolic blood pressure in the first 20 min after induction, p = 0.001. There were no pneumatic leg compression-related complications. Pneumatic leg compression reduced post-induction hypotension in elderly patients undergoing robot-assisted laparoscopic prostatectomy, suggesting that it is an effective and safe intervention to prevent post-induction hypotension among elderly patients undergoing general anaesthesia.     

Evaluation of timolol maleate gel for management of hard-to-heal chronic venous leg ulcers. Phase II randomised-controlled study

BackgroundVenous leg ulcers (VLUs) often take a very long time to heal. Timolol maleate has been reported as displaying efficacy in healing of VLUs.ObjectivesTo evaluate the efficacy of timolol maleate gel in the management of hard-to-heal VLUs and to assess its safety as a topical agent during 12 weeks of use in combination with conventional treatment.MethodsA prospective, phase-II randomised-controlled trial with a sample size based on Fleming's one-stage design (P0 = 0.25, P1 = 0.45, alpha = 0.1, beta = 0.2) was planned. Patients with VLUs present for ≥ 24 weeks and with ≥ 50% granulation tissue were included. One drop of sustained-release timolol gel (Timoptol® LP 0.5%, Santen, Tampere, Finland) per 6 cm² VLU area was applied every 2 days for 12 weeks in timolol-treated patients, as adjuvant therapy to the standard care protocol (interface dressing and multilayer venous compression). Controls received standard care alone. The primary endpoint was to obtain ≥ 40% reduction in ulcer area at week 12 (W12).ResultsForty-three patients were randomised to the study, with 40 receiving at least one treatment and included in the analysis: 21 timolol-treated patients and 19 controls (females: 70%; median age: 72.5 [range 35–93] years). At W12, ≥ 40% ulcer-area reduction was achieved in 14/21 (67%) timolol-treated patients vs. 6/19 (32%) controls. No serious adverse events occurred. Local wound infections not requiring systemic antibiotics occurred in 5 cases in the timolol group and in one case in the controls.ConclusionsThese results support the benefit and safety of using timolol maleate to manage hard-to-heal VLUs, but confirmation is required in a larger multicentre randomised phase-III study.     

Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.     

Education in people with venous leg ulcers based on a brochure about compression therapy: A quasi‐randomised controlled trial

Brochures are a useful supplement to patient education. There is increasing evidence that they are an effective medium to support patient satisfaction, adherence, and empowerment. This study aims to produce reliable data on how much patients with venous leg ulcer (VLU) may profit from a brochure that focuses on VLU and on measures and aims of the related compression therapy. The evaluation took part from October 2018 until March 2019 and included 136 patients with VLU and related compression therapy. They were randomly sorted into a case group and a control group of 68 patients each. The case group received a brochure about venous disease and compression therapy and filled in a questionnaire after reading. The questions ranged from basic knowledge about VLU and compression therapy to aspects of self‐care. The control group answered the same questions without previous reading of the brochure. The results show that in almost every aspect, the patients in the case group were better informed about their diseases, the compression therapy, and how they may support the measures adequately. This study suggests that patients with VLU may profit from a brochure that explains their disease and the related compression therapy. Better knowledge and understanding may strengthen their empowerment and adherence.     

不同直腿抬高扳腿法对推拿治疗腰椎间盘突出症临床疗效的影响

目的探讨不同直腿抬高扳腿法对推拿治疗腰椎间盘突出症临床疗效的影响。方法选择2018年5月—2019年1月在广西中医药大学第一附属医院推拿科治疗的腰椎间盘突出症患者100例,随机分为对照组与观察组各50例。2组均采用相同的松解类推拿手法治疗,治疗过程中观察组采用改进的直腿抬高扳腿法,对照组采用常规的直腿抬高扳腿法。2组均以治疗6次为1个疗程,疗程之间间隔1 d,共治疗4个疗程。观察2组治疗效果及治疗前后患侧直腿抬高角度、疼痛视觉模拟评分(VAS评分)、日本骨科学会腰椎功能量表评分(JOA评分)变化和治疗过程中可能发生的不良反应。结果观察组与对照组愈显率分别为74%(37/50)、54%(27/50),总有效率分别为96%(48/50)、94%(47/50),观察组愈显率明显高于对照组(P<0.05),2组总有效率比较差异无统计学意义(P>0.05)。与治疗前比较,治疗后2组患者患侧直腿抬高角度均显著增大(P均<0.05),VAS评分均显著降低(P均<0.05),JOA评分均显著升高(P均<0.05);治疗后2组比较,观察组患侧直腿抬高角度显著大于对照组(P<0.05),VAS评分显著低于对照组(P<0.05),JOA评分显著高于对照组(P<0.05)。观察组患者均未出现疼痛症状加重等手法反应,对照组有7例患者出现不同程度的腰臀疼痛症状加重。结论在采用推拿手法治疗腰椎间盘突出症时,改进的直腿抬高扳腿法较常规的直腿抬高扳腿法疗效更为显著,可能发生的不良反应更少。     

调神针刺法治疗不安腿综合征临床观察

目的:观察调神针刺法治疗不安腿综合征及其伴发睡眠障碍、焦虑情绪的临床疗效,为调神法在临床上的应用提供理论依据。方法:将60例患者随机分为观察组和对照组,每组30例。对照组予常规针刺治疗,穴取足三里、阳陵泉、悬钟等下肢局部腧穴;观察组在对照组取穴基础上加用百会、神庭、本神。两组均每日治疗1次,每周6d,1周为一疗程,连续治疗3个疗程。观察两组患者治疗前后国际不安腿综合征评定量表(IRLS)、匹兹堡睡眠质量指数(PSQI)和汉密尔顿焦虑量表(HAMA)评分变化。结果:治疗后两组患者IRLS评分、PSQI和HAMA总评分均较治疗前下降(P<0.05),且观察组治疗后各评分改善均优于对照组(P<0.05)。结论:在常规针刺基础上,调神针刺法可明显减轻不安腿综合征患者的下肢不适感,改善其睡眠障碍和焦虑情绪,疗效优于单纯常规针刺。     

Effectiveness of combined conventional treatment with a tailored exercise training program on wound healing in patients with venous leg ulcer: A randomized controlled trial

IntroductionVenous leg ulcer (VLU) is a therapeutic challenge. The mainstay of care is compression therapy and wound care. Exercise is also recommended for facilitating wound healing. This study aimed to determine whether adding tailored exercise training to conventional treatment would be superior on wound healing, ankle mobility, calf muscle function, and functional ability compared to those with the conventional treatment alone.MethodsA randomized controlled trial, single-blinded was conducted. VLU patients were randomized to the conventional treatment plus tailored exercise training (intervention group) and the conventional treatment alone (control group) (12/group). The conventional treatment contained foam dressing and short-stretch bandage, while the tailored exercise training consisted of stretching, resistive, and aerobic exercise sessions (3-day/week, for 12-week). Primary outcomes included healing rate and wound size parameters. Secondary outcomes were ankle range of motion (ROM), calf circumference, calf muscle endurance and strength, and functional ability. All outcomes were assessed at baseline, 6-, and 12-week intervention.ResultsThe intervention group had a higher trend of healing rate after 12-week training than those in the control group, but this trend was not significantly different (92% versus 58%, p = 0.06). After training, the intervention group had significantly decreased wound size. The intervention group had significantly higher ankle ROM and dorsiflexor muscle strength after 6- and 12-week training than those in the control group.ConclusionAdding the tailored exercise training incorporated with the conventional treatment may provide a greater tendency on wound healing and have the potential to improve ankle mobility than the conventional treatment alone.Trial registration numberTCTR20170405002.     

Biomarker directed chronic wound therapy – A new treatment paradigm

AimTo develop a treatment paradigm for chronic leg ulcers that incorporates new biomarkers of wound healing with currently available therapies.MethodsRecently published data on GM-CSF and MMP-13 as biomarkers of venous leg ulcer (VLU) healing status with accuracies of 92% and 78% respectively, was reviewed along with the wound bed preparation (WBP) theoretical framework for treatment of chronic wounds. The broad categories of wound treatments that align with the WBP concepts were identified. These were then considered in a hierarchical order that initially improves the wound bed and subsequently incorporates more complex advanced wound therapies. Identification of the non-healing status of the wound is the driver to advance through the different treatments.ResultsA point of care test of wound healing status is the key to the systematic use of currently available therapies for chronic leg ulcers in a timely fashion. The different therapies address – debridement, moisture control, bacterial contamination, protease inhibition, formation of granulation tissue, application of growth factors, application of matrix constructs, and application of cellular components. Progression through this hierarchical order of therapies is directed by the leg ulcer remaining in a non-healing state with the previous therapies having been implemented.ConclusionCombining a validated point of care test of wound healing with a systematic approach to wound therapies, has the potential to create a new paradigm of chronic leg ulcer treatment - biomarker directed wound therapy.     

Nurse-led patient education for persons suffering from a venous leg ulcer in outpatient's clinics and homecare settings: A scoping review

Aim of this studyTo provide an overview of the available nurse-led individualized educational interventions, for persons with Venous Leg Ulcer (VLUs) in an outpatient or homecare settings.Materials and methodsFor this scoping review, a search was performed between December 2019 and January 2020. To identify sources of evidence a systematic search was conducted in PubMed, CINAHL, Embase, PsychINFO, Web of Science and LiSSa as well as in clinical trial registers to identify sources of evidence. All types of evidence associated with a nurse led-intervention were included.ResultsFifteen sources of evidence met the inclusion criteria. Educational sessions varied in modality, content and duration. Education sessions were face to face and supported by written materiel. The content focused on compression therapy and exercises. The duration and numbers of sessions varied. The most reported health related outcomes was wound healing.ConclusionThis scoping review provides a broad overview of the available evidence and ongoing research for individualized nurse-led education persons with VLUs. Variability in the literature was found, which suggests that more intervention studies are needed to test and evaluate efficacy of nurse-led patient education.