Endoscopic versus transcranial procurement of allograft tympano-ossicular systems: a prospective double-blind randomized controlled audit

Allograft tympano-ossicular systems (ATOS) have proven their use over many decades in tympanoplasty and reconstruction after resection of cholesteatoma. The transcranial bone plug technique has been used in the past 50 years to procure en bloc ATOS (tympanic membrane with malleus, incus and stapes attached). Recently, our group reported the feasibility of the endoscopic procurement technique. The aim of this study was to assess whether clinical outcome is equivalent in ATOS acquired by using the endoscopic procurement technique compared to ATOS acquired by using the transcranial technique. A double-blind randomized controlled audit was performed in a tertiary referral center in patients that underwent allograft tympanoplasty because of chronic otitis media with and without cholesteatoma. Allograft epithelialisation was evaluated at the short-term postoperative visit by microscopic examination. Failures were reported if reperforation was observed. Fifty patients underwent allograft tympanoplasty: 34 received endoscopically procured ATOS and 16 received transcranially procured ATOS. One failed case was observed, in the endoscopic procurement group. We did not observe a statistically significant difference between the two groups in failure rate. This study demonstrates equivalence of the clinical outcome of allograft tympanoplasty using either endoscopic or transcranial procured ATOS and therefore indicates that the endoscopic technique can be considered the new standard procurement technique. Especially because the endoscopic procurement technique has several advantages compared to the former transcranial procurement technique: it avoids risk of prion transmission and it is faster while lacking any noticeable incision.     

Peripheral regional analgesia with femoral catheter versus intravenous patient controlled analgesia after total knee arthroplasty: a prospective randomized study

The aim of this study is to compare the effects of femoral analgesia (FA) with 0.25% levobupivacain and intravenous patient controlled analgesia (PCA) with morphine on postoperative pain assessed by a visual-analog scale (VAS) score and their complications during the first 24 postoperative hours after the a total knee arthroplasty in a prospective randomized study. Secondary outcomes included: morphine use, patient satisfaction, complication of analgesia and duration of hospital stay. We analyzed 71 patients with an ASA score of II or III. The patients were randomized into two groups: group PCA (n = 36) was given the PCA pump, which contained morphine; and group FA (n = 35) was given first a bolus dose, then a continuous infusion 0.25% levobupivacain via a femoral catheter. The assessment of VAS was performed every 2 hours. There were no differences between the PCA and FA groups regarding demographic characteristics, operation duration, ASA score distribution, duration of hospital stay and satisfaction with analgesia (although there were more satisfied patients in the FA group). Significant differences were noted in the quantity of morphine used (higher values were in the PCA group; p < 0.001). More complications were recorded in PCA group (p < 0.001). The VAS score was lower in the FA group (p < 0.001). The highest difference occurred 4 hours after the operation, with the PCA group having significantly higher VAS score values compared to the FA group. Femoral analgesia leads to a stronger pain relief with less side effects, less morphine use and more patient satisfaction than intravenous PCA with morphine.     

Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants

Although textured silicone breast implants have been shown to reduce the incidence of capsular contracture, there is little evidence if this effect is maintained in the long term. It has been 10 years since the double-blind randomized trial in which 53 patients received either Mentor smooth (26) or textured silicone gel implants (27). Of the 14 patients who were not known to have developed a contracture in the smooth group, 11 were reviewed. Three had bilateral contractures. In the textured group, 18 of the 24 patients not known to have contractures were reviewed. None had developed contractures. At 10 years, the incidence of capsular contracture was 65 percent of patients with smooth implants (an increase of 6 percent on the 3-year results) and 11 percent for the textured implant patients (no change on the 3-year results). A database containing the details of 1100 patients reinforces these results by examining the differences in contracture rates of textured, smooth, and polyurethane-coated implants. The effect of submuscular placement on reducing contracture rates regardless of texturing is discussed, as is the apparent increase in capsular contracture in patients who smoke.     

Effect of balance taping on trunk stabilizer muscles for back extensor muscle endurance: A randomized controlled study

Objective:The purpose of this study was to investigate the difference in back extensor muscle endurance before and after kinesiology tape application to all back stabilizer muscles and to the erector spinae alone.Methods:We assessed 32 adults (16 men and 16 women), randomly divided into two groups. In the erector spinae taping (EST) group, kinesiology tape was applied only to the erector spinae, and in the total muscle taping (TMT) group, kinesiology tape was applied to the erector spinae, latissimus dorsi, lower trapezius, internal oblique abdominis, and external oblique abdominis.Results:Both groups showed significant difference in terms of back extensor muscle endurance after kinesiology tape application (p<0.05). Between-group comparison revealed that the TMT group had more back extensor muscle endurance than the EST group (p<0.05) after kinesiology tape application.Conclusions:These findings indicate that, to improve back extensor muscle endurance, kinesiology tape should be applied to all back stabilizer muscles, rather than to the erector spinae muscles alone.     

Treatment of COVID-19 patients with quercetin: a prospective,single center,randomized, controlled trial

Scientific research continues on new preventive and therapeutic strategies against severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2). So far, there is no proven curative treatment, and a valid alternative therapeutic approach needs to be developed. This study is designed to evaluate the effect of quercetin in COVID-19 treatment. This was a single-centre, prospective randomized controlled cohort study. Routine care versus QCB (quercetin, vitamin C, bromelain) supplementation was compared between 429 patients with at least one chronic disease and moderate-to-severe respiratory symptoms. Demographic features, signs, laboratory results and drug administration data of patients were recorded. The endpoint was that QCB supplementation was continued throughout the follow-up period from study baseline to discharge, intubation, or death. The most common complaints at the time of hospital admission were fatigue (62.4%), cough (61.1%), anorexia (57%), thirst (53.7%), respiratory distress (51%) and chills (48.3%). The decrease in CRP and ferritin levels was higher in the QCB group (all Ps were < 0.05). In the QCB group, the increase in platelet and lymphocyte counts was higher (all Ps were < 0.05). QCB did not reduce the risk of events during follow-up. Adjustments for statistically significant parameters, including the lung stage, use of favipiravir and presence of comorbidity did not change the results. While there was no difference between the groups in terms of event frequency, the QCB group had more advanced pulmonary findings. QCB supplement is shown to have a positive effect on laboratory recovery. While there was no difference between the groups in terms of event frequency, QCB supplement group had more advanced pulmonar findings, and QCB supplement is shown to have a positive effect on laboratory recovery/results. Therefore, we conclude that further studies involving different doses and plasma level measurements are required to reveal the dose/response relationship and bioavailability of QCB for a better understanding of the role of QCB in the treatment of SARS CoV-2.     

The prevention of emesis in plastic surgery: a randomized,prospective study

Perhaps the most unpleasant experience following outpatient plastic surgery procedures is postoperative nausea and vomiting. Postoperative nausea and vomiting often results in delayed recovery time and unintended admission, and it can be a contributing factor to the formation of hematoma following rhytidectomy. Ondansetron (Zofran) has proven benefit in preventing postoperative nausea and vomiting if given before general anesthesia in a variety of surgical procedures. Its utility in cases performed under conscious sedation has not been determined. The purpose of this study was (1) to test the ability of prophylactic ondansetron to prevent postoperative nausea and vomiting in plastic surgery cases performed under conscious sedation, and (2) to determine relative risk factors for postoperative nausea and vomiting and a selection policy for the administration of antiemetic prophylaxis. This was a prospective, randomized, double-blind study. One hundred twenty patients were enrolled after giving informed consent. Patients received a single dose of either placebo or ondansetron (4 mg intravenously) before administration of sedation. Sedation administration followed a standardized institutional protocol, using midazolam and fentanyl. Data were recorded from a series of three questionnaires: preoperatively, immediately postoperatively, and at the time of the first office return. Data were confirmed by means of telephone interview, chart analysis, and nursing documentation. Multivariate analysis was conducted. Nausea and emesis occurred with an overall frequency of 33 percent and 22 percent, respectively. Postoperative nausea and vomiting was associated with statistically longer recovery periods. The incidence of emesis was statistically higher among women, among those undergoing facial rejuvenation, and among those with a history of opioid-induced emesis or postoperative nausea and vomiting following a previous operation (p < 0.05). The incidence of postoperative nausea and vomiting paralleled increases in case duration; the incidence of emesis was zero in cases less than 90 minutes in duration. Ondansetron significantly reduced the incidence of emesis overall (placebo, 30 percent; ondansetron, 13 percent; p < 0.05). Postoperative perception of nausea was significantly lower among those who had received ondansetron (p < 0.05). These results confirm the efficacy of ondansetron for the prevention of postoperative nausea and vomiting in plastic surgery cases under conscious sedation. In those who are at increased risk, prophylaxis should be considered. Such risks include female gender, facial rejuvenation procedures, and a patient history of opioid-induced emesis or postoperative nausea and vomiting following a prior operation. The zero incidence of emesis in cases less than 90 minutes does not support the routine use of prophylaxis in such cases. Patient satisfaction in plastic surgery is derived from the overall subjective experience of the event as much as by the final result. By remaining attentive to patient concerns and optimizing perioperative care, we can improve the subjective experience for our patients.     

Cellulite treatment: a myth or reality: a prospective randomized, controlled trial of two therapies, endermologie and aminophylline cream

Cellulite is a common phenomenon that particularly affects the thighs and buttocks of women. Little scientific evidence exists to support any of the many advertised treatments for it. A total of 52 of 69 women, who were divided into three groups, completed a 12-week, randomized, controlled trial in which the effectiveness of two different treatments for cellulite was assessed. The patients acted as their own controls. The treatments investigated were twice-daily application of aminophylline cream and twice-weekly treatment with Endermologie ES1. Group 1 (double blind) received aminophylline to one thigh/buttock and a placebo cream to the other. Group 2 (singly blind) received Endermologie to one thigh/buttock. Group 3 received Endermologie to both sides and used the same cream regimen as group 1. Results were assessed subjectively by the patient and by clinical examination and photographic assessment by the surgeon (before and after the trial). Morphologic assessment included body mass index, thigh girth at two points, and thigh fat depth measurement by ultrasound. No statistical difference existed in measurements between legs for any of the treatment groups (paired t test, p > 0.4). The best subjective assessment, by the patients themselves, revealed that only 3 of 35 aminophylline-treated legs and 10 of 35 Endermologie-treated legs had their cellulite appearance improved. The authors do not believe that either of these two treatments is effective in improving the appearance of cellulite.     

Improvement of long-term prognosis in patients with ovarian cancers by adjuvant sizofiran immunotherapy: a prospective randomized controlled study

The effect of immunotherapy using sizofiran (SPG) on the prognosis of patients with ovarian cancers was prospectively studied in a total of 68 patients, who were randomly assigned to either a cisplatin, adriamycin and cyclophosphamide (PAC) therapy group or a PAC plus SPG combination therapy group.The survival rate was significantly higher in patients with stage Ic, II or III cancers treated with the PAC plus SPG combination, compared with the patients treated with PAC alone. In the SPG-receiving patients with stage Ic or more advanced cancers who were treated with four cycles or more of PAC, the outcome was improved (Cox-Mantel, p=0.074; generalized Kruskal-Wallis, p=0.032). Similar improvement was also observed in the patients with non-serous adenocarcinomas (Cox-Mantel, p-0.076; generalized Krukal-Wallis, p=0.045). No side effects attributable to SPG were recorded.The present results suggest that the use of SPG in combination with long-term chemotherapy improves the postoperative prognosis in ovarian cancer patients.Abbreviations SPG sizofiran     

Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

Background

Epidural anaesthesia is used extensively for cardiothoracic and vascular surgery in some centres, but not in others, with argument over the safety of the technique in patients who are usually extensively anticoagulated before, during, and after surgery. The principle concern is bleeding in the epidural space, leading to transient or persistent neurological problems.

Methods

We performed an extensive systematic review to find published cohorts of use of epidural catheters during vascular, cardiac, and thoracic surgery, using electronic searching, hand searching, and reference lists of retrieved articles.

Results

Twelve studies included 14,105 patients, of whom 5,026 (36%) had vascular surgery, 4,971 (35%) cardiac surgery, and 4,108 (29%) thoracic surgery. There were no cases of epidural haematoma, giving maximum risks following epidural anaesthesia in cardiac, thoracic, and vascular surgery of 1 in 1,700, 1 in 1,400 and 1 in 1,700 respectively. In all these surgery types combined the maximum expected rate would be 1 in 4,700. In all these patients combined there were eight cases of transient neurological injury, a rate of 1 in 1,700 (95% confidence interval 1 in 3,300 to 1 in 850). There were no cases of persistent neurological injury (maximum expected rate 1 in 4,600).

Conclusion

These estimates for cardiothoracic epidural anaesthesia should be the worst case. Limitations are inadequate denominators for different types of surgery in anticoagulated cardiothoracic or vascular patients more at risk of bleeding.     

Prostaglandin-induced abortion and outcome of subsequent pregnancies: a prospective controlled study

We analysed a prospective series of 204 pregnancies occurring in 168 women after a prostaglandin-induced abortion. The mean (±standard error of mean) interval between abortion and first subsequent conception was 10·4 ± 0·6 months; no patient reported secondary subfertility.Fifty-five of the subsequent pregnancies were terminated, 23 during the second trimester, again using prostaglandins. Of the 149 pregnancies not terminated, 127 were delivered at term, and 19 spontaneously aborted, seven during the second trimester; there was one missed abortion and two ectopic pregnancies. Morbidity in the 127 term pregnancies was infrequent; spontaneous preterm labour occurred in three patients, and four singleton infants weighed less than 2500 g at birth. There was no apparent association between morbidity in the subsequent pregnancies and the period of gestation at the time of the previous abortion, route of prostaglandin administration, or need for post-abortion curettage.The results obtained overall were very similar to a control group of 612 women consecutively admitted for delivery or abortion to the Oxford obstetrical and gynaecological units. There was, however, an increased incidence of spontaneous abortion and placenta praevia after prostaglandin-induced abortion, and the multigravidae in that group had a longer average duration of labour than the control group. Sixty-five per cent of the post-abortion pregnancies were unplanned compared with 36% of the control group.     

Preoperative education with image illustrations enhances the effect of tetracaine mucilage in alleviating postoperative catheter-related bladder discomfort: a prospective,randomized, controlled study

Background

Catheter-related bladder discomfort (CRBD), secondary to catheterization of urinary bladder is distressing. The aim of this study was to assess the efficacy of preoperative education on CRBD with image illustration for alleviating CRBD.

Methods

Sixty adult male patients, undergoing elective colonal and rectal surgery, were randomized to receive tetracaine mucilage instilled into the urethra and applied to the catheter (tetracain group), or receive tetracaine mucilage in combination with image illustration on CRBD (image group) before urethral catheterization. The incidence and severity of CRBD were assessed at 0.5, 1, 2, and 6?h after patients’ extubation. The severity of postoperative pain, incidence of postoperative agitation and other adverse events were also recorded.

Results

Patients in image group reported remarkably less CRBD than those in tetracaine group at 0.5,1, 2 and 6?h after extubation (20, 20, 6.7 and 6.7% v.s. 60, 73.3, 53.3 and 53.3%, respectively, P<0.01). Severe CRBD was not reported in either group. However, the incidence of moderate CRBD was significantly lower in image group, with 6.7% at 1?h and thereafter none occurred, compared to 6.7% at 0.5?h, and increasing to 20% at 1?h, 2?h and 6?h in tetracaine group, respectively. Moreover, patients in image group suffered less moderate to severe postoperative pain than that of tetracaine group (13.3% v.s. 40.0% at 1?h, P?=?0.039, 33.3% v.s. 60% at 2?h and 6?h, P?=?0.038).

Conclusions

Preoperative education on uretheral catheterization via image illustrations could enhance the effect of tetracaine mucilage in reducing both the incidence and severity of CRBD.

Trial registration

The trial was registered at www,clinicaltrials.gov with registration number NCT03199105 (retrospectively registered). Date of trial registration which is “June 26, 2017”.

     

Morning versus evening dosing of desloratadine in seasonal allergic rhinitis: a randomized controlled study [ISRCTN23032971].

BACKGROUND: A circadian rhythm of symptoms has been reported in allergic rhinitis and some studies have shown the dosing time of antihistamines to be of importance for optimizing symptom relief in this disease. The objective of this study was to examine the efficacy of morning vs. evening dosing of the antihistamine desloratadine at different time points during the day. METHODS: Patients >/= 18 years, with seasonal allergic rhinitis received desloratadine 5 mg orally once daily in the morning (AM-group) or evening (PM-group) for two weeks. Rhinorrhea, nasal congestion, sneezing and eye symptoms were scored morning and evening. Wilcoxon rank sum and 2-way ANOVA test were used. RESULTS: Six-hundred and sixty-three patients were randomized; 336 in the AM-group; 327 in the PM-group. No statistically significant differences were seen between the AM and PM group at any time points. In the sub-groups with higher morning or evening total symptom score no difference in treatment efficacy was seen whether the dose was taken 12 or 24 hours before the higher score time. There was a circadian variation in baseline total symptom score; highest during daytime and lowest at night. The circadian variation in symptoms was reduced during treatment. This reduction was highest for daytime symptoms. CONCLUSIONS: A circadian rhythm was seen for most symptoms being more pronounced during daytime. This was less apparent after treatment with desloratadine. No statistically significant difference in efficacy was seen whether desloratadine was given in the morning or in the evening. This gives the patients more flexibility in choosing dosing time.     

Velopharyngeal surgery: a prospective randomized study of pharyngeal flaps and sphincter pharyngoplasties

Residual velopharyngeal insufficiency after palatal repair varies from 10 to 20 percent in most centers. Secondary velopharyngeal surgery to correct residual velopharyngeal insufficiency in patients with cleft palate is a topic frequently discussed in the medical literature. Several authors have reported that varying the operative approach according to the findings of videonasopharyngoscopy and multiview videofluoroscopy significantly improved the success of velopharyngeal surgery. This article compares two surgical techniques for correcting residual velopharyngeal insufficiency, namely pharyngeal flap and sphincter pharyngoplasty. Both techniques were carefully planned according to the findings of videonasopharyngoscopy and multiview videofluoroscopy. Fifty patients with cleft palate and residual velopharyngeal insufficiency were randomly divided into two groups: 25 in group 1 and 25 in group 2. Patients in group 1 were operated on by using a customized pharyngeal flap according to the findings of videonasopharyngoscopy and multiview videofluoroscopy in each case. Those in group 2 received a sphincter pharyngoplasty also customized according to the findings of videonasopharyngoscopy and multiview videofluoroscopy. The median age of the patients in both groups was not significantly different (p > 0.5). The frequency of residual velopharyngeal insufficiency after the individualized velopharyngeal surgery was not significantly different between the patient groups (12 percent versus 16 percent; p > 0.05). It seems that customized pharyngeal flaps and sphincter pharyngoplasties performed according to the findings of videonasopharyngoscopy and multiview videofluoroscopy are safe and reliable procedures for treating residual velopharyngeal insufficiency in cleft palate patients.