Single-center Prospective Randomized Trial Research Articles

Functional Outcomes of Immediate Weightbearing After Arthroscopic Lateral Ankle Ligament Repair: A Prospective Randomized Single-Center Trial.

Previous studies have revealed that early postoperative rehabilitation of chronic lateral ankle instability is just as crucial as surgical intervention. Immediate weightbearing has yielded good clinical results; however, randomized controlled studies have been limited. To compare the clinical outcomes of patients with immediate weightbearing after lateral ankle ligament repair with those with delayed weightbearing after 2 weeks in a prospective randomized controlled study. Randomized controlled clinical trial; Level of evidence, 1. Patients who underwent arthroscopic anterior talofibular ligament repair between August 2021 and December 2022 were randomized into 2 groups-immediate weightbearing with a hard ankle brace and nonweightbearing casting for 2 weeks followed by cast removal and weightbearing. Primary outcomes were the ankle function scores as assessed using the visual analog scale at rest and during activities, the American Orthopaedic Foot & Ankle Society (AOFAS) score, and the Karlsson Ankle Functional Score (Karlsson score). Secondary outcomes were the time to return to unsupported walking, jogging, work, and exercise and change in the ankle range of motion (ROM) at 3-, 6-, and 12-month follow-ups. A total of 88 participants were included, consisting of 58 men and 30 women, with a mean age of 30.26 years. Computerized randomization resulted in 44 patients per group. These 2 groups displayed no difference in the AOFAS score, Karlsson score, and ankle ROM at all follow-ups. Patients who underwent immediate weightbearing had a significantly shorter time of returning to unsupported walking (P < .001). No differences were observed in the time of returning to work, jogging, and sports exercise. For patients with chronic ankle instability after arthroscopic anterior talofibular ligament repair, immediate weightbearing allowed patients to return to unsupported walking more quickly and had no negative effects on the AOFAS score, Karlsson score, times of returning to normal life, jogging, sports exercise, and ankle ROM at 3-, 6-, and 12-month follow-ups compared with cast fixation. ChiCTR2100049612 (Chinese Clinical Trial Registry; https://www.chictr.org.cn/).

Volatile versus propofol sedation after cardiac valve surgery: a single-center prospective randomized controlled trial

BackgroundOptimal intensive care of patients undergoing valve surgery is a complex balancing act between sedation for monitoring and timely postoperative awakening. It remains unclear, if these requirements can be fulfilled by volatile sedations in intensive care medicine in an efficient manner. Therefore, this study aimed to assess the time to extubation and secondary the workload required.MethodsWe conducted a prospective randomized single-center trial at a tertiary university hospital to evaluate the postoperative management of open valve surgery patients. The study was randomized with regard to the use of volatile sedation compared to propofol sedation. Sedation was discontinued 60 min after admission for critical postoperative monitoring.ResultsWe observed a significantly earlier extubation (91 ± 39 min vs. 167 ± 77 min; p < 0.001), eye-opening (86 ± 28 min vs. 151 ± 71 min; p < 0.001) and command compliance (93 ± 38 min vs. 164 ± 75 min; p < 0.001) using volatile sedation, which in turn was associated with a significantly increased workload of a median of 9:56 min (± 4:16 min) set-up time. We did not observe any differences in complications. Cardiopulmonary bypass time did not differ between the groups 101 (IQR 81; 113) versus 112 (IQR 79; 136) minutes p = 0.36.ConclusionsUsing volatile sedation is associated with few minutes additional workload in assembling and enables a significantly accelerated evaluation of vulnerable patient groups. Volatile sedation has considerable advantages and emerges as a safe sedation technique in our vulnerable study population.Trial registration: Clinical trials registration (NCT04958668) was completed on 1 July 2021.

A PROSPECTIVE RANDOMIZED TRIAL OF OPERATIVE VERSUS NONOPERATIVE MANAGEMENT OF FRACTURES OF THE HUMERAL DIAPHYSIS: THE HUMERAL SHAFT FRACTURE FIXATION (HU-FIX) STUDY

This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture.70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL).At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups.Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr.

Biobased polyester versus synthetic fiberglass casts for treating stable upper limb fractures in children: a randomized controlled trial

BackgroundStable upper limb fractures, such as radius, ulna, or distal humerus fractures, are common pediatric orthopedic traumas that are traditionally managed with cast immobilization. The commonly used synthetic fiberglass cast is light and water resistant but may promote skin itchiness during casting, which is a common complaint of patients. In addition, these diisocyanate-based casts have been proven to be toxic and may cause asthma. Herein, we introduce a novel biobased polyester cast to compare its clinical outcomes and patient satisfaction with conventional synthetic fiberglass casts.MethodsFrom Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3–4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.ResultsAccording to the radiographs taken on the day of cast removal, there was no loss of reduction in both groups. The incidence of skin problems was 3.4 times higher in the synthetic fiberglass group than in the biobased polyester group. For the subjective questionnaire, the biobased polyester cast was preferred in every sub-item.ConclusionsOur study strongly suggested that the novel biobased polyester cast provides matching stability to conventional fiberglass casts and improves patient satisfaction in an eco-friendlier and safer way.Trial registrationClinicalTrials.gov Protocol Registration and Results System (https://www.clinicaltrials.gov/; ID: NCT06102603; Date: 26/10/2023).

Influence of cardiorespiratory training program on the intercellular adhesion molecule level in patients with postmastectomy syndrome

To evaluate the influence of 12-week aerobic dynamic training program of moderate intensity on the endothelial dysfunction laboratory markers and life quality in patients with PMS. Single-center prospective randomized trial included 40 patients with PMS divided into study (20 patients) and comparative (20 patients) groups, as well as 20 healthy female volunteers. The expression level of soluble intercellular adhesion molecule-1 (ICAM-1) and platelet endothelial cell adhesion molecule-1 (PECAM-1) were evaluated in all participants at baseline by enzyme-linked immunosorbent assay method, and additionally psychological and physical component of health by SF-36 questionnaire were assessed in patients with PMS. The group of patients with PMS after BC treatment had increased level of ICAM-1 in long-term period, that may indicate endothelial dysfunction. Statistically significant decrease of endothelial dysfunction laboratory markers was revealed in patients with PMS, who underwent the course of cardiorespiratory training. In the same time, the dynamics of changes in ICAM-1 was higher in the study group than in comparative group. Further, improvement of physical and psychological components of health by SF-36 questionnaire was found. The program of cardiorespiratory trainings of moderate intensity in patients, who had BC treatment a year ago, decreases intercellular adhesion molecules level that may show an improvement of endothelial dysfunction.

SC216 - En-bloc versus conventional transurethral resection of bladder tumors: single-center prospective randomized trial

SC216 - En-bloc versus conventional transurethral resection of bladder tumors: single-center prospective randomized trial

Effect of Hemadsorption Therapy in Critically Ill Patients with COVID-19 (CYTOCOV-19): A Prospective Randomized Controlled Pilot Trial

Introduction: Immunomodulatory therapies have shown beneficial effects in patients with severe COVID-19. Patients with hypercytokinemia might benefit from the removal of inflammatory mediators via hemadsorption. Methods: Single-center prospective randomized trial at the University Medical Center Hamburg-Eppendorf (Germany). Patients with confirmed COVID-19, refractory shock (norepinephrine ≥0.2 µg/kg/min to maintain a mean arterial pressure ≥65 mm Hg), interleukin-6 (IL-6) ≥500 ng/L, and an indication for renal replacement therapy or extracorporeal membrane oxygenation were included. Patients received either hemadsorption therapy (HT) or standard medical therapy (SMT). For HT, a CytoSorb® adsorber was used for up to 5 days and was replaced every 18–24 h. The primary endpoint was sustained hemodynamic improvement (norepinephrine ≤0.05 µg/kg/min ≥24 h). Results: Of 242 screened patients, 24 were randomized and assigned to either HT (N = 12) or SMT (N = 12). Both groups had similar severity as assessed by SAPS II (median 75 points HT group vs. 79 SMT group, p = 0.590) and SOFA (17 vs. 16, p = 0.551). Median IL-6 levels were 2,269 (IQR 948–3,679) and 3,747 (1,301–5,415) ng/L in the HT and SMT groups at baseline, respectively (p = 0.378). Shock resolution (primary endpoint) was reached in 33% (4/12) versus 17% (2/12) in the HT and SMT groups, respectively (p = 0.640). Twenty-eight-day mortality was 58% (7/12) in the HT compared to 67% (8/12) in the SMT group (p = 1.0). During the treatment period of 5 days, 6/12 (50%) of the SMT patients died, in contrast to 1/12 (8%) in the HT group. Conclusion: HT was associated with a non-significant trend toward clinical improvement within the intervention period. In selected patients, HT might be an option for stabilization before transfer and further therapeutic decisions. This finding warrants further investigation in larger trials.

A0153 - En-bloc versus conventional transurethral resection of bladder tumors: Single-center prospective randomized trial

A0153 - En-bloc versus conventional transurethral resection of bladder tumors: Single-center prospective randomized trial

The use of combined extracorporeal detoxification in the treatment of toxic rhabdomyolysis complicated by acute kidney injury: single-center prospective randomized trial

INTRODUCTION. Rhabdomyolysis (RM) occurs in 40–60 % of patients with acute poisoning and is accompanied by acute kidney injury (AKI). The most effective method of treatment is the use of extracorporeal detoxification. The most promising is the combined methods of detoxification. OBJECTIVES. Improve outcomes in patients with toxic RM complicated by AKI through early use of selective hemosorption and hemodiafiltration. MATERIALS AND METHODS. The study included 57 patients with toxic genesis RM complicated by AKI. The first group received standard intensive therapy. For the treatment of the second group at the early stage of AKI, hemodiafiltration and selective hemoperfusion were used. We performed a comparative analysis of the dynamics of the main clinical and laboratory parameters, as well as treatment outcomes between groups. RESULTS. The use of selective hemoperfusion and hemodiafiltration at the early stage of AKI allowed to increase the decrease in the level of myoglobin in the blood from 26.3 to 88.0 % and KIM-1 in the urine from 76.1 to 99.0 % during the first week of treatment in the ICU (intensive care unit). Combined detoxification reduced the duration of RRT use from 15 to 6 days, which led to a significant decrease in the level of hospital mortality from 14.3 to 6.9 %, the duration of inpatient treatment from 19.5 to 11 days and the period of stay in the ICU from 11 to 4 days. CONCLUSIONS. Early use of combined extracorporeal detoxification leads to a significant decrease in the level of endogenous intoxication factors, which ultimately made it possible to reduce the duration of treatment in the ICU, hospital and reduce the level of hospital mortality.

A simple size-tailored algorithm for the removal of chest drain following minimally invasive lobectomy: a prospective randomized study

BackgroundThe pleural space can resorb 0.11–0.36 ml/kg of body weight/hour (h) per hemithorax. There are only a limited number of studies on thresholds for chest drain removal (CDR) and all are based on arbitrary amounts, for example, 300 ml/day. We studied an individualized size-based threshold for CDR–specifically 5 ml/kg, a simple, easily applicable measure.MethodsThis is a single-center prospective randomized trial enrolling 80 patients undergoing VATS lobectomy. There were two groups: an experimental (E) group, in which once the daily output went down to 5 ml/kg the chest drain was removed and a control (C) group, with chest drain removal as per our current practice of less than 250 ml/day.ResultsThe groups did not differ in pre- and peri- and postoperative characteristics, except for chest drain duration (mean, SD 2.02 ± 0.97 vs. 3.25 ± 1.39 days, p < 0.001) and length of hospital stay (median, IQR 4.5; 3 vs. 6; 2.75 days, p = 0.008) in favor of E group. The re-intervention rate was the same in both groups (once in each group).ConclusionThe new threshold for chest drain removal following thoracoscopic lobectomy of 5 ml/kg/d leads to both shorter chest drainage and hospital stay without apparent increase in morbidity. (Clinical registration number: DRKS00014252).

Surgical outcomes of diaphragmatic resection during cytoreductive surgery for advanced gynecological ovarian neoplasia: A randomized single center clinical trial - DRAGON

IntroductionOvarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection. MethodsThis was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A included patients receiving intra-operative thoracostomy tube placement (TP); Arm B patients did not receive thoracostomy tube placement (NTP). After surgery, all patients underwent seriate chest x-ray and ultrasound to record thoracic complications. Statistical analysis included uni- and multivariable logistic regression model (proportional odds model). ResultsThree hundred seventy-one patients were screened and 88 patients were enrolled: 44 in arm A and B, respectively. No statistically significant differences for intra-operative (p = 0.291) and any grade of post-operative complication (p = 0.072) were detected, while 6.8% of patients in arm A and 22.7% in arm B experienced severe respiratory symptoms (p = 0.035); 18.2% of patients in arm A had a moderate/large pleural effusion versus 65.9% in arm B (p < 0.0001). At multivariable analysis, results confirmed that the NTP-group had a higher risk to receive post-operative thoracostomy tube placement due to pleural effusion than the TP-group (odds ratio [95% Confidence Interval] = 14.5 [3.7–57.4]). ConclusionsThoracostomy intra-operative tube placement after diaphragmatic resection is effective to prevent post-operative thoracic complications. The extension of resection does not influence outcomes and the risk of post-operative thoracentesis or TP remain elevated.

SC15 - En-bloc versus conventional transurethral resection of bladder tumors: interim analysis of a single-center prospective randomized trial

SC15 - En-bloc versus conventional transurethral resection of bladder tumors: interim analysis of a single-center prospective randomized trial

Hystérectomie cœlioscopique ambulatoire en France : étude randomisée unicentrique

ObjectiveTo demonstrate the feasibility of outpatient laparoscopic hysterectomy using the assessment of post-operative quality of life. MethodsA prospective randomized single-center trial was performed in France between 2013 and 2016. A total of 42 patients needed laparoscopic hysterectomy was included. Postoperative quality of life was assessed using the standardized Euroquol questionnaire. Patients filled the score before the operation and then on the 3rd and 30th postoperative day. Secondary outcomes were assessment of postoperative pain, overall quality of life, analgesic use, and anxiety. The patients were randomized into two groups, group A with a conventional hospital stay of 2 to 3 days and group B with a short stay and a discharge the day after the intervention. ResultsTwenty-one patients were randomized to group A as well as group B. We did not find any significant differences between the two groups in our study either on our primary outcome or in the seconds ones. On day 3, the average of Euroquol score was 0.68 for group A against 0.50 for group B (P=0.05). Likewise, the scores for postoperative pain were similar with 70.6 in group A and 61.8 in group B (P=0.21). The trend was the same for quality of life score or anxiety. ConclusionOur study shows the possibility and the safety of outpatient laparoscopic hysterectomy.

P0759 - En-bloc versus conventional transurethral resection of bladder tumors: Interim analysis of a single-center prospective randomized trial

P0759 - En-bloc versus conventional transurethral resection of bladder tumors: Interim analysis of a single-center prospective randomized trial

Libération arthroscopique combinée à une fixation en simple rang ou double rang d’une rupture traumatique du supra-épineux associée à capsulite rétractile réfractaire au traitement conservateur - étude prospective randomisée

BackgroundThere are few previous studies on traumatic supraspinatus tear with adhesive capsulitis. This study used arthroscopic release with single-row fixation or double-row suture bridge fixation to treat adhesive capsulitis of the shoulder with rotator cuff tears. Further, the clinical efficacy of arthroscopic release with single-row fixation and double-row suture bridge fixation was compared. HypothesesArthroscopic release combined with single-row fixation or double-row suture bridge fixation showed good clinical outcomes in patients with traumatic supraspinatus tear with adhesive capsulitis. MethodsA single-center prospective randomized trial was performed from June 2013 to June 2017. Of the 68 patients with traumatic supraspinatus tear and adhesive capsulitis who underwent arthroscopic release, 34 (22 with tear measuring ≤3cm and 12 with tear measuring >3cm) were included in the single-row fixation group and 34 (20 with tear measuring ≤3cm and 14 with tear measuring >3cm) were included in the double-row suture bridge fixation group. The visual analogue scale (VAS) score, University of California Los Angeles (UCLA) and American Shoulder and Elbow Surgeons (ASES) shoulder scores, range of motion, time to achieve satisfactory scores, and rotator cuff re-tear rate were compared between the groups. ResultsThe range of motion, VAS score, UCLA and ASES shoulder scores significantly improved after surgery in both groups. There was a significant difference in the UCLA and ASES shoulder scores, time to achieve satisfactory scores, and rotator cuff re-tear rates in patients with tears measuring >3cm between the groups. ConclusionsArthroscopic release combined with single-row fixation or double-row suture bridge fixation showed good clinical outcomes in patients with traumatic supraspinatus tear with adhesive capsulitis. Therefore, the capsule of the shoulder should be thoroughly released to achieve such outcomes. For patients with rotator cuff tears measuring >3cm, double-row suture bridge fixation was superior to single-row fixation and the rotator cuff re-tear rate was low. Level of evidenceI; prospective, randomized trial, treatment study.

Arthroscopic release combined with single-row fixation or double-row suture bridge fixation in patients with traumatic supraspinatus tear and adhesive capsulitis non-responsive to conservative management: A prospective randomized trial

BackgroundThere are few previous studies on traumatic supraspinatus tear with adhesive capsulitis. This study used arthroscopic release with single-row fixation or double-row suture bridge fixation to treat adhesive capsulitis of the shoulder with rotator cuff tears. Further, the clinical efficacy of arthroscopic release with single-row fixation and double-row suture bridge fixation was compared. HypothesesArthroscopic release combined with single-row fixation or double-row suture bridge fixation showed good clinical outcomes in patients with traumatic supraspinatus tear with adhesive capsulitis. MethodsA single-center prospective randomized trial was performed from June 2013 to June 2017. Of the 68 patients with traumatic supraspinatus tear and adhesive capsulitis who underwent arthroscopic release, 34 (22 with tear measuring≤3cm and 12 with tear measuring>3cm) were included in the single-row fixation group and 34 (20 with tear measuring≤3cm and 14 with tear measuring>3cm) were included in the double-row suture bridge fixation group. The visual analogue scale (VAS) score, University of California Los Angeles (UCLA) and American Shoulder and Elbow Surgeons (ASES) shoulder scores, range of motion, time to achieve satisfactory scores, and rotator cuff re-tear rate were compared between the groups. ResultsThe range of motion, VAS score, UCLA and ASES shoulder scores significantly improved after surgery in both groups. There was a significant difference in the UCLA and ASES shoulder scores, time to achieve satisfactory scores, and rotator cuff re-tear rates in patients with tears measuring>3cm between the groups. ConclusionsArthroscopic release combined with single-row fixation or double-row suture bridge fixation showed good clinical outcomes in patients with traumatic supraspinatus tear with adhesive capsulitis. Therefore, the capsule of the shoulder should be thoroughly released to achieve such outcomes. For patients with rotator cuff tears measuring>3cm, double-row suture bridge fixation was superior to single-row fixation and the rotator cuff re-tear rate was low. Level of evidenceI; prospective, randomized trial, treatment study.

App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients (APCOT): Protocol for a Prospective Randomized Controlled Trial.

BackgroundHead and neck cancers (HNCs) are among the most common malignancies, which often require multimodal treatment that includes radiation therapy and chemotherapy. Patients with HNC have a high burden of symptoms due to both the damaging effects of the tumor and the aggressive multimodal treatment. Close symptom monitoring over the course of the disease may help to identify patients in need of medical interventions.ObjectiveThis APCOT (App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients) trial is designed to assess the feasibility of monitoring HNC patients during the course of (chemo)radiation therapy daily using a mobile app. Additionally, symptom patterns, patient satisfaction, and quality of life will be measured in app-monitored patients in comparison to a patient cohort receiving standard-of-care physician appointments, and health economy aspects of app monitoring will be analyzed.MethodsThis prospective randomized single-center trial will evaluate the feasibility of integrating electronic patient-reported outcome measures (ePROMs) into the treatment workflow of HNC patients. Patients undergoing definitive or adjuvant (chemo)radiation therapy as part of their HNC treatment at the Department of Radiation Oncology, University Medical Center Freiburg (Freiburg, Germany) will receive weekly physician appointments and additional appointments as requested to monitor and potentially treat symptoms during the course of treatment. Patients in the experimental arm will additionally be monitored daily using a dedicated app regarding their disease- and treatment-related symptoms, quality of life, and need for personal physician appointments. The feasibility of ePROM monitoring will be tested as the primary endpoint and will be defined if ≥80% of enrolled patients have answered ≥80% of their daily app-based questions. Quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires, and patient satisfaction will be measured by the validated Patient Satisfaction Questionnaire Short Form at the initiation, in the middle, and at completion of radiation therapy, as well as at follow-up examinations. Additionally, the number and duration of physician appointments during the course of radiation therapy will be quantified for both ePROM-monitored and standard-of-care patients.ResultsThis trial will enroll 100 patients who will be randomized (1:1) between the experimental arm with ePROM monitoring and the control arm with standard patient care. Recruitment will take 18 months, and trial completion is planned at 24 months after enrollment of the last patient.ConclusionsThis trial will establish the feasibility of close ePROM monitoring of HNC patients undergoing (chemo)radiation therapy. The results can form the basis for further trials investigating potential clinical benefits of detailed symptom monitoring and patient-centered care in HNC patients regarding oncologic outcomes and quality of life.Trial RegistrationGerman Clinical Trials Register DRKS00020491; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020491International Registered Report Identifier (IRRID)PRR1-10.2196/21693

Comparison of two regimens for patients with thyroid‑associated ophthalmopathy receiving intravenous methyl prednisolone: A single center prospective randomized trial

Intravenous (i.v.) glucocorticoid is recommended for active moderate-to-severe thyroid-associated ophthalmopathy (TAO). However, the details of the treatment schedule are still debatable. The present prospective randomized trial was performed to compare clinical outcomes and serum cytokines between the two regimens. A cohort of 90 patients with active moderate-to-severe TAO was randomized to receive i.v. methyl prednisolone on a weekly protocol or daily scheme. The response rate was evaluated at the 12-week follow-up visit. Serum interleukin (IL)-2, IL-6 and IL-17 levels were measured in 160 patients with TAO, 60 patients with isolated Graves' disease (GD) and 60 normal control (NC) at baseline, as well as patients with active moderate-to-severe TAO at the 12th week after treatment. The daily scheme had a higher response rate than the weekly protocol without a significant difference (77.8 vs. 63.6%, P>0.05). No major adverse events were recorded under either regimen. Overall, minor events were more common on the daily scheme (11.36 vs. 4.35%, P<0.05)than on the weekly protocol, whereas the deterioration of eye symptoms (two patients) was only reported on the weekly protocol. At baseline, the IL-17 level in the TAO group was higher than that in the isolated GD and NC groups (P<0.05). In addition, the IL-17 level in the active TAO group was higher than that in the inactive TAO group (P<0.05). Furthermore, the IL-17 level had significantly decreased under the two regimens at the 12-week visit (P<0.05). In conclusion, for patients with active moderate-to-severe TAO, daily i.v. glucocorticoid therapy has a relative higher response rate than the weekly protocol with a few more minor adverse events. These two regimens have their own merits with regard to adverse effects. IL-17 has the potential to be a biomarker for evaluating TAO activity and treatment effects.

Effects of an Informational Video About Anesthesia on Pre- and Post-Elective Cesarean Section Anxiety and Recovery: A Randomized Controlled Trial

BackgroundShowing an informational anesthesia video can reduce the preoperative anxiety of parturients undergoing elective cesarean section (CS). However, the best method for presenting such videos remains unclear, and whether such videos can reduce the anxiety level of women during the entire perioperative period for CS (including preoperative and postoperative) has not been studied yet.Material/MethodsThis study was a single-center prospective randomized trial. We randomly divided 121 pregnant women who were scheduled to undergo elective cesarean section (CS) into 2 groups: one group was shown an informational video (video group) and another group was not (control group). Spielberger’s state-trait anxiety inventory was used to evaluate the perioperative anxiety level of parturient women at 3 time points: 1 day before CS, after video education, and 2 days after CS. Salivary cortisol level was evaluated to assess the patients’ anxiety level at these 3 time points. Finally, the maternal satisfaction scale for CS and an obstetric quality-of-recovery score (OBsQoR-11) were used to evaluate the satisfaction and recovery of the parturient women 2 days after CS.ResultsWatching a video about anesthesia significantly reduced the anxiety level of the parturient women during the perioperative period (1 day before CS: p=1.00, p=0.96; after video education: p<0.01, p=0.004; 2 days after CS: p=0.01, p=0.01). The postoperative satisfaction scores were significantly improved in the video group (p=0.007). OBsQoR-11 scores in the video group and control group were not significantly different (p=0.48). Maternal anxiety level was moderately positively correlated with cortisol hormone level.ConclusionsShowing an informational video about anesthesia (video+education) can significantly reduce perioperative anxiety and improve satisfaction after CS. Although it did not improve the postoperative recovery, it was still significant for anesthesia.

Long-term results of a single-center prospective randomized trial assessing efficacy of a shortened course of adjuvant chemotherapy after radical cystectomy in patients with locally advanced bladder cancer.

IntroductionThis study assesses the efficacy and tolerability of two cycles of adjuvant chemotherapy (AC) with gemcitabine and cisplatin after radical cystectomy in patients with a high risk of progression of muscle-invasive urothelial bladder cancer as compared to chemotherapy at relapse, in a prospective randomized study.Material and methodsFrom 2008 to 2013, all patients after radical cystectomy at our institution for primary or recurrent urothelial bladder cancer with stage pT3-4 and/or pN+ on histopathology and without contraindications to combination cisplatin-based chemotherapy, were randomized either to two cycles of gemcitabine and cisplatin chemotherapy or to follow-up and chemotherapy at the time of relapse. The study endpoints were overall, cancer-specific, and disease-free survival.ResultsThe study included 100 patients, of whom 53 received AC and the other 47 were assigned to the control arm. Out of 53 allocated to AC arm, 16 patients did not start chemotherapy or received only one cycle of AC. The median follow-up for patients in the AC and control arms was 88 and 86 months, respectively. In the AC arm the hazard ratio for death from any cause, death from bladder cancer, and disease relapse were 0.70 (95% CI 0.45–1.11; p = 0.13), 0.84 (95% CI 0.50–1.41; p = 0.51), and 0.77 (95% CI 0.46–1.28; p = 0.31), respectively.ConclusionsTwo cycles of AC with gemcitabine and cisplatin in patients with high-risk urothelial bladder cancer after radical cystectomy does not improve overall, cancer-specific, and disease-free survival. Only 53% of patients randomized to AC received the entire planned treatment.