Minimally invasive surgical management of primary venous ulcers vs. compression treatment: a randomized clinical trial.

OBJECTIVES: to compare minimally invasive surgical haemodynamic correction of reflux (CHIVA) with compression in the treatment of venous ulceration.DESIGN: prospective randomised study. MATERIALS AND METHODS: from a cohort of 80 patients with 87 venous leg ulcers, 47 were randomised to either surgery or compression. RESULTS: at a mean follow-up of 3 years, healing was 100% (31 days) in the surgical and 96% (63 days), in the compression group (p<0.02). The recurrence rate was 9% in the surgical and 38% in the compression group (p<0.05). In the surgical group, all plethysmographic parameters except ejection fraction, had improved significantly at 6 months in the surgical group, and at 3 years residual volume fraction remained in the normal range. Finally, quality of life significantly improved in the operated group. CONCLUSIONS: this study supports the effectiveness of surgical therapy for leg ulceration secondary to superficial venous reflux.     

A randomized,controlled trial of negative pressure wound therapy of pressure ulcers via a novel polyurethane foam

The objectives of the study were (1) to look for any local, clinically apparent response, within and around a debrided wound, to a novel biocompatible polyurethane foam during repeated, short‐term implantation, and (2) to assess the material's efficacy as a negative pressure wound therapy (NPWT) interface compared with a widely used, commercially available foam. Twenty pressure ulcers in 18 patients underwent surgical debridement, then randomization to receive novel treatment or control foam as the wound interface for NPWT. Dressing changes every 2–3 days allowed qualitative wound assessment and quantitative measurement to compare outcomes. No adverse reaction was observed in any patient receiving the new foam. The new “novel foam” performed as a NPWT interface as effectively as the control “standard foam.” In deep wounds, the new foam was easier to remove, fragmented less, and showed less retention than the control foam. No marginal in‐growth occurred, making removal less traumatic and reducing bleeding from cavity wall granulations. The results support previous large animal studies, and independent ISO10993 testing, that the new foam is safe and biocompatible. Its efficacy as an NPWT interface, nontraumatic removal with low fragmentation and retention rate, favors the new material, especially in deep cavity wounds.     

Acetic acid versus radiofrequency ablation for the treatment of hepatocellular carcinoma: A randomized controlled trial

PurposeThe purpose of this prospective study was to compare the efficacy of percutaneous acetic acid (PAAI) to that of radiofrequency ablation (RFA) in the treatment of small (≤ 5 cm) hepatocellular carcinoma (HCC) using a randomized trial.Material and methodsConsecutive patients with small HCC underwent clinical, biochemical, and imaging evaluation. Those fulfilling the inclusion criteria (Child's A/B cirrhosis, less than 5 HCC nodules, HCC nodules ≤ 5 cm diameter, no extrahepatic disease, patent portal vein, normal coagulation profile with informed consent) were randomly assigned to receive RFA or PAAI. Tumor response and survival rate were estimated. Non-inferiority margin of 10% difference was taken for effectivity of PAAI compared to RFA.ResultsOf the 86 patients screened, 55 patients with 67 HCC nodules were included. There were 40 men and 15 women with a mean age of 54.3 ± 10.5 (SD) years (range: 28–71 years). Of these, 26 patients had PAAI and 29 had RFA. The clinical, demographic and imaging profiles of the two groups were similar. Complete response was non-inferior to RFA [PAAI 75% and RFA 83.3%, difference 8.3% CI (−12.5% to 29.2%)]. Lower limit of this 95% CI (−12.5%) was lower than the 10% non-inferiority margin difference (8.3%). Survival rates were similar at 12 months (PAAI, 81.6% vs. RFA, 71.9%; P = 0.68) and at 30 months (PAAI, 54.4% vs. RFA, 52%; P = 0.50).ConclusionPAAI and RFA have similar efficacy in treating small HCC. PAAI could thus be a cost-effective alternative in situations where RFA is either unavailable or unaffordable.     

益精方治疗弱精子症的临床随机对照研究

目的:观察益精方治疗弱精子症的临床疗效。方法:450例患者以信封法随机分为治疗组(益精方组)300例和对照组(五子衍宗丸+左卡尼汀口服液组)150例,经精液常规检查诊为弱精子症,治疗组服用益精方,每天1剂,温水冲服,分2次服用,对照组服用五子衍宗丸+左卡尼汀口服液,五子衍宗丸9 g,口服,每日2次,左卡尼汀口服液,10 ml,口服,每日2次,均治疗3个月,于治疗前及治疗后的第1个月(第27~33天)、2个月(第57~63天)和3个月(第87~93天)分别检测患者的精液常规,比较治疗前后精子浓度、前向运动精子百分率(PR)、精子总活力(PR+NP)等精液参数的变化。结果:两组患者治疗前精液常规检查结果无显著差异(P0.05)。治疗组治疗1、2、3个月时,精子浓度分别为49.66±10.91、55.21±11.46、74.90±13.07(×10~6/ml),PR分别为23.81±2.56、26.12±2.34、32.17±1.62(%),PR+NP分别为34.17±3.43、36.59±3.36、47.08±2.97(%),精液体积分别为3.15±1.06、3.12±0.90、3.27±0.78(ml),液化时间分别为31.68±3.14、30.38±3.44、30.86±2.42(min),组内比较显示,治疗后精子浓度、PR、PR+NP较治疗前差异显著(P0.001),精液体积、液化时间差异不明显(P0.05)。对照组治疗1、2、3个月时,精子浓度分别为40.53±8.32、47.51±12.73、56.14±11.98(×10~6/ml),PR分别为25.17±2.64、27.23±2.25、31.89±2.27(%),PR+NP分别为33.89±2.26、37.38±4.79、40.35±3.06(%),精液体积分别为3.16±1.78、3.15±0.96、3.12±0.65(ml),液化时间分别为29.36±4.25、28.21±3.26、28.33±3.59(min),组内比较显示,治疗后精子浓度、PR、PR+NP较治疗前差异显著(P0.001),精液体积、液化时间差异不明显(P0.05)。组间比较显示,治疗组精子浓度及PR+NP增长率较对照组有显著差异(P0.001),PR增长率两组间差异不明显(P0.05)。结论:益精方可在生精周期多个阶段调控精子的发生,提高弱精子症患者的PR及PR+NP比例,是一种有效的治疗弱精子症的方剂。     

Hypothenar fat pad flap vs conventional open release in primary carpal tunnel syndrome:A randomized controlled trial

AIM To compared outcomes between the hypothenar fat pad flap(HTFPF) and conventional open carpal tunnel release(COR) in primary carpal tunnel syndrome(CTS). METHODS Forty-five patients(49 hands) were enrolled into the study from January 2014 to March 2016, 8 patients were excluded. Randomization was conducted in 37 patients(41 hands) by computer generated(Block of four randomization) into COR and HTFPF group. Nerve conduction study(NCS) included distal sensory latency(DSL), distal motor latency(DML), sensory amplitude (S-amp), motor amplitude(M-amp) and sensory nerve conduction velocity(SCV) were examined at 6 and 12 wk after CTR. Levine score, grip and pinch strength, pain [visual analog scale(VAS)], 2-point discrimination(2-PD), Semmes-Weinstein monofilament test(SWM), Phalen test and Tinel's sign were evaluated in order to compare treatment outcomes.RESULTS The COR group, 19 patients(20 hands) mean age 50.4 years. The HTFPF group, 20 patients(21 hands) mean age 53.3 years. Finally 33 patients(36 hands) were analysed, 5 patients were loss follow-up, 17 hands in COR and 19 hands in HTFPF group. NCS revealed significant difference of DSL in HTFPF group at 6 wk(P 0.05) compared with the COR group. S-amp was significant improved postoperatively in both groups(P 0.05) but not significant difference between two groups. No significant difference of DML, M-amp and SCV postoperatively in both groups and between two groups. Levine score, pain(VAS), grip and pinch strength, 2-PD, SWM, Phalen test and Tinel's sign were improved postoperatively in both groups, but there was no significant difference between two groups.CONCLUSION There is no advantage outcome in primary CTS for having additional HTFPF procedure in CTR. COR is still the standard treatment. Nevertheless, improvement of DSL and S-amp could be observed at 6 wk postoperatively.     

Oxygen delivery-guided perfusion for the prevention of acute kidney injury: A randomized controlled trial

ObjectivesThe reduction of postoperative acute kidney injury in patients undergoing cardiopulmonary bypass surgery using an oxygen delivery-guided perfusion strategy (oxygen delivery strategy) for cardiopulmonary bypass management compared with a fixed flow perfusion (conventional strategy) remains controversial. The purpose of this study was to determine whether a oxygen delivery strategy would reduce the incidence of postoperative acute kidney injury in patients undergoing cardiopulmonary bypass surgery.MethodsWe randomly enrolled 300 patients undergoing cardiopulmonary bypass surgery. Patients were randomly assigned to a oxygen delivery strategy (maintaining a oxygen delivery index value >300 mL/min/m² through pump flow adjustments during cardiopulmonary bypass) or a conventional strategy (a target pump flow was determined on the basis of the body surface area). The primary end point was the development of acute kidney injury. Secondary end points were the red blood cell transfusion rate and number of red blood cell units, intubation time, postoperative length of stay in the intensive care unit and the hospital, predischarge estimated glomerular filtration rate, and hospital mortality.ResultsAcute kidney injury occurred in 20 patients (14.6%) receiving the oxygen delivery strategy and in 42 patients (30.4%) receiving the conventional strategy (relative risk, 0.48; 95% confidence interval, 0.30-0.77; P = .002). The secondary end points were not significantly different between strategies. In a prespecified subgroup analysis of patients who had nadir hematocrit less than 23% or body surface area less than 1.40 m², the oxygen delivery strategy seemed to be superior to the conventional strategy and the existence of quantitative interactions was suggested.ConclusionsAn oxygen delivery strategy for cardiopulmonary bypass management was superior to a conventional strategy with respect to preventing the development of acute kidney injury.     

A prospective randomized controlled trial of sclerotherapy vs ligation in the prophylactic treatment of high-risk esophageal varices

Background: Endoscopic ligation (EVL) and endoscopic sclerotherapy (EIS) are both effective in the treatment of bleeding esophageal varices, but the efficacy of the two techniques in the prophylaxis of first variceal bleeding has not been investigated. The aim of this study was to investigate the frequency of first variceal bleeding, the recurrence of varices, and survival after treatment with the two techniques, as compared to a nontreated control group. Methods: A total of 157 patients with liver cirrhosis and advanced esophageal varices with no previous history of upper gastrointestinal bleeding were randomly assigned to either an EIS group (n= 55), an EVL group (n= 52), or a nontreated control group (n= 50). After the eradication of esophageal varices in the EIS and in EVL groups and in all control patients, the endoscopic examination was performed at 3-month intervals. Results: There were no significant differences between EIS and EVL in the eradication rate of esophageal varices (85% in the EIS group versus 81% in the EVL group). The mean number of sessions required to obtain eradication was lower in the EVL group than in the EIS group (4.8 ± 1.8 versus 6.2 ± 2.0; p= 0.0003), but the recurrence of esophageal varices was higher in the EVL group (31% versus 11%; p= 0.01). Total mortality was significantly lower in the EIS patients than in the controls (20% versus 38%; p= 0.04). It was also lower, but not significantly, in the EVL patients than in the controls (23% versus 38%; p= 0.10). A significant decrease in variceal bleeding was observed both in sclerotherapy cases (20%) and controls (54%; p= 0.0005) and in ligation cases and controls (29%; p= 0.01). No significant difference in bleeding episodes was observed between the sclerotherapy and ligation cases (p= 0.29). No serious complications were observed either in the EIS or EVL groups. Conclusions: EIS and EVL are similarly effective in the prevention of first variceal bleeding. The choice between EIS and EVL depends on the skill of the endoscopic unit. For highly experienced surgeons facing no complications, sclerotherapy seems to be preferable; for all others, it is technically easier to perform ligation. Received: 29 June 1998/Accepted: 18 September 1998     

单孔腹腔镜与传统腹腔镜胆囊切除术治疗效果比较

目的 探讨单孔腹腔镜(SILC)与传统腹腔镜两种术式的安全性和可行性.方法 选取胆囊疾病患者54例随机分为SILC组(n=26)和三通道腹腔镜胆囊切除术(3PLC)组(n=28).收集患者年龄、体质量、身高、体质量指数(BMI)、手术时间、疼痛分数、中途转换手术率、切口满意度评分等临床资料,并进行了12个月的随访.结果 两组患者在性别、年龄、体质量、身高和BMI方面比较差异无统计学意义(P＞0.05).SILC组手术时间长于3PLC组[(56.9 ±15.8) min比(35.2±8.7) min,P＜0.01].应用相同的麻醉药品后SILC组在术后第1天较3PLC组疼痛分数更高,总的疼痛分数两者相似,差异无统计学意义(P＞0.05).SILC组患者术后伤口并发症发生率更高,但术后疝发生率相同.SILC组切口满意度评分分数更高[(11.7±0.8)分比(10.1±1.2)分,P＜0.05].结论 SILC较3PLC治疗单纯胆道疾病安全、有效.     

Effects of marine n‐3 fatty acid supplementation in renal transplantation: A randomized controlled trial

Marine n‐3 fatty acids (FAs) may exert beneficial effects on inflammation, fibrosis, and endothelial function, which could preserve renal graft function. In this randomized controlled trial, 132 Norwegian renal transplant recipients received either 2.6 g of marine n‐3 FAs or olive oil (control) daily for 44 weeks, in addition to standard care. Thirty patients did not complete the trial. The primary endpoint was change (Δ) in measured glomerular filtration rate (mGFR) during follow‐up. We found no significant difference in Δ mGFR between the marine n‐3 FA group and controls (6.7 vs 3.8 mL/min per 1.73 m², P = .15). Significant beneficial effects from marine n‐3 FA supplementation were, however, seen in secondary endpoints plasma triglycerides, plasma high‐sensitivity C‐reactive protein, and brachial artery flow‐mediated dilation. In the per‐protocol population, the renal graft indices percent interstitial fibrosis and Chronic Allograft Damage Index also were significantly lower in the marine n‐3 FA group. The cumulative incidence of adverse events did not differ between the marine n‐3 FA group (n = 218) and controls (n = 240). In conclusion, marine FA supplementation did not improve renal function compared with controls, but was safe, lowered plasma triglyceride and high‐sensitivity C‐reactive protein levels, and improved endothelial function (Clinical.Trials.gov identifier NCT01744067).     

Oral clonidine vs midazolam in the prevention of sevoflurane-induced agitation in children. a prospective, randomized, controlled trial

Background: This randomized, double-blind study tested the hypothesis that,in comparison with midazolam, premedication with oral clonidinereduces the incidence of emergence agitation in preschool childrenanaesthetized with sevoflurane. Methods: Sixty-eight ASA I–II children undergoing circumcisionwere randomized into three groups to receive different oralpremedication given 30 min before anaesthesia: midazolam 0.5mg kg^–1, clonidine 2 µg kg^–1, and clonidine4 µg kg^–1. Sevoflurane anaesthesia was administeredvia a facemask (O₂/N₂O: 40/60). Analgesia was with penile block(bupivacaine 0.5% 0.3 ml kg^–1) and rectal paracetamol(30 mg kg^–1). During the first postoperative hour, childrenwere evaluated using a modified ‘objective pain scale’. Results: Only the 4 µg kg^–1 dose of clonidine was associatedwith a significant reduction in emergence agitation. Fewer childrenin the clonidine 4 µg kg^–1 group displayed agitation(25%) than in the midazolam group (60%) (P = 0.025). Incidenceof hypotension and bradycardia, time to first micturition andfirst drink did not differ among groups. Conclusions: In comparison with midazolam, clonidine 4 µg kg^–1reduced sevoflurane-induced emergence agitation without increasingpostoperative side-effects.     

Tape versus cast for non-operative treatment of primary patellar dislocation: a randomized controlled trial

Purpose

We hypothesized that taping results in better short-term functional outcome and comparable redislocation rates.

Methods

In a prospective randomised clinical trial, 18 patients with a primary patellar dislocation ≥18?years old without accompanying fractures or previous surgery to the knee were included. After 1?week of dorsal splinting, they were randomized into two groups: taping and cylinder cast immobilization. Physical examination and knee function according to the Lysholm Knee Scoring Scale were taken at 1-, 6- and 12-week and at 1- and 5-year follow-up. We also compared the redislocation rates.

Results

Taping resulted in a significantly better Lysholm score at 6 and 12?weeks post-dislocation (P?P?Conclusion Tape bandage immobilization seems superior to a cylinder cast even after 5?years.