Prospective Randomized Controlled Clinical Trial Research Articles

Comparing two photodynamic therapy protocols for high-grade cervical intraepithelial neoplasia

SignificancePhotodynamic therapy (PDT) is a therapeutical modality which offers a minimally invasive alternative for high-grade cervical intraepithelial neoplasia (CIN) treatment. Approachthis prospective randomized controlled clinical trial aims to compare two PDT protocols for histopathologically similar high-grade CIN treatment. In protocol 1, only ectocervix is treated; in protocol 2, the patients had both the ectocervix and endocervix illuminated simultaneously with LED plus LASER (a cylindrical diffuser fiber was coupled inside the squamocolumnar junction). In both groups was applied 20% MAL overnight and the irradiance delivered was 120 mW/cm2, for 21 minutes, in a fluency rate of 150 J/cm2. Resultsafter two years of follow-up, group 1 showed 96% cure and group 2, 87%. Conclusionsno significant difference was observed between the two protocols. However, the number of patients who completed the two-year follow-up is still low and we expect better conclusions with more patients followed.

Virtual Surgical Guidance Improves Quality of Life Following Scapular Free-Flap Reconstruction of Maxillary Defects

BackgroundThe best way for maxillary reconstruction remains the subject of debate, with negative impacts on the patient’s quality of life (QOL). PurposeThis study was designed to evaluate the QOL outcomes following maxillary reconstruction using a scapular-free flap, with and without the computer-aided design and computer-aided manufacturing (CAD/CAM) technique. Study design and patientsA prospective randomized controlled clinical trial was performed following the CONSORT checklist. To be included, patients suffering from maxillary defects without previous surgery or lymph node involvement were selected. Patients with poor oncological prognosis, deficient performance status, preoperative chemotherapy, or radiotherapy, besides vascular contraindications, were excluded. Predictor variableThe predictor variable was the reconstruction technique, grouped into two equal categories. Patients were randomly assigned to reconstruction with a scapular-free flap, with the control group not utilizing a guide and the study group utilizing a CAD/CAM-customized guide. Outcome variableThe primary outcome variable was the various domains of QOL, measured using the University of Washington-QOL (UW-QOL) score, 12 months after reconstruction. Covariatesage; sex; scapular flap side; and maxillary defect tumour type, histopathology, side, length, class, sagittal, and axial differential areas were considered. AnalysesShapiro-Wilk and Kolmogorov-Smirnov tests were performed for normality. For comparisons between the two groups, Student’s t-test and Mann-Whitney test were used. The category variables were compared using the chi-square test. p ≤ 0.05 was considered statistically significant. ResultsThe sample was composed of twenty-two eligible patients, eleven in each group. The mean age of the control group was (50.09±17.14) years, and 45.45% were male, while in the study group, the mean age was (48.36±14.14) years, with 36.36% male. All the patients were evaluated, showing statistically significant differences between control and study groups in terms of pain, appearance, chewing, swallowing, speech, and shoulder (p ≤ 0.05), indicating that the scapular-free flap with a CAD/CAM osteotomy guide had improved the patient's QOL. ConclusionsThe findings of this study indicate that VSP with a CAD/CAM customized osteotomy guide using a scapular-free flap can improve QOL in maxillary reconstruction in terms of pain, appearance, chewing and swallowing food, pronouncing words, and shoulder QOL outcomes.

DOP29 Capsule endoscopy-guided proactive treatment versus standard treatment of patients with quiescent Crohn’s Disease: The CURE-CD randomized controlled trial

Abstract Background Optimal strategies for treat-to-target in Crohn’s disease (CD) are still being sought. We aimed to examine the value of capsule endoscopy (CE) to guide proactive treatment optimization in patients with CD Methods A prospective randomized controlled clinical trial with temporally-restricted blinding. Patients with CD involving the small bowel who were in clinical remission (CDAI<150) for over three months were enrolled. Baseline clinical, biomarker, imaging, patency capsule and CE assessments were performed. ‘High risk’ patients, defined as CE Lewis score ≥350 were randomized to either proactive treatment optimization or continued standard care for 24 months. ‘Low risk’ patients with Lewis score<350 continued their standard care. All patients repeated CE every six months for 24 months. Primary outcome was the rate of clinical exacerbation (CDAI increase>70 points and CDAI>150 or hospitalization/surgery) in the standard-care versus the proactive-care sub-groups of high-risk patients, at 24 months. Secondary outcomes included risk of flare in the low-risk versus the standard-care high-risk arms, and predictive profiles for flare of calprotectin, MRI, intestinal ultrasound and Lewis score. Results Out of 118 screened patients, 60 were enrolled (20 in each of the three arms). Treatment intensification in CE-determined high-risk group, who were allocated to proactive treatment, comprised biologic dose-escalation (n=11/20), starting a biologic (8/20) or swapping a biologic (1/20) at study entry. Notably, 9/20 proactive-group patients underwent a second optimization following detected inflammation on subsequent semi-annual CE studies. Clinical exacerbation by 24 months (primary outcome) occurred in 5/20 (25%) of the high-risk proactive-treatment group versus 14/20 (70%) of the high-risk standard-care group (OR=0.14, 95%CI 0.04-0.57, p=0.006). For secondary outcomes, the rate of clinical flare in the standard-care low-risk group was numerically but not significantly lower than in standard-care high-risk group (9/20 versus 14/20, respectively, OR 0.3, 0.1-1.3, P=0.11). Among all patients continuing standard care, baseline CE Lewis score was higher among relapsers versus non-relapsers (median 450, IQR [225-900] versus 225, [135-600], respectively, p=0.03). Of 251 CE ingested, there was a single (0.4%) temporarily-retained CE, which resolved spontaneously. Conclusion In a randomized strategy-finding controlled trial, proactive treatment optimization based on CE findings in patients with CD in remission, proved safe and superior for prevention of disease exacerbation compared with continued standard care. NCT03555058

Comparative Effectiveness Randomized Clinical Trial Using Next-generation Microbial Sequencing to Direct Prophylactic Antibiotic Choice Before Urologic Stone Lithotripsy Using an Interprofessional Model

BackgroundNext-generation sequencing (NGS) methods for microbial profiling have increased sensitivity to detect urinary pathogens. ObjectiveTo determine whether NGS microbial profiling can be used to guide antibiotic prophylaxis and reduce infection compared with the standard of care. Design, setting, and participantsA prospective randomized controlled clinical trial of patients undergoing urologic stone interventions at an academic health center from December 2019 to January 2022 was conducted. Urine was collected at the preoperative visit for standard culture and intervention NGS diagnostics. Evaluable patients were culture negative, met 2-wk follow-up, and did not cancel surgery. Of 240 individuals (control = 121, intervention = 119), 83 control and 74 intervention patients were evaluable. InterventionMicrobial findings (paired quantitative polymerase chain reaction and NGS) were sent to an infectious disease pharmacist to recommend prophylactic antimicrobial regimen. Outcome measurements and statistical analysisThe primary outcome was postoperative urinary infection within the follow-up period (Fisher’s exact test). The primary outcome was analyzed by modified intent-to-treat (mITT) and per-protocol analyses. Secondary endpoints considered included positive culture concordance, antibiotic use, and adverse events. Additional post hoc analyses investigated factors contributing to infection (univariate logistic regression). Results and limitationsThe intervention significantly reduced postsurgical urinary infection risk by 7.1% (–0.73%, 15%) compared with the standard of care in the mITT analysis (1.4% vs 8.4%, p = 0.045) or by 8.5% (0.88%, 16%) compared with the per-protocol analysis (0% vs 8.5%, p = 0.032). NGS-guided treatment altered the distribution of antibiotics used (p = 0.025), and antibiotics poorly matched with NGS findings were associated with increased infection odds (odds ratio [OR] = 5.9, p = 0.046). Women were at greater odds to develop infection (OR = 10, p = 0.03) and possessed differentiated microbial profiles (p < 0.001). ConclusionsUrinary microbial NGS-guided antibiotic prophylaxis before endoscopic urologic stone lithotripsy improves antibiotic selection to reduce healthcare-associated urinary infections; however, treatment efficacy may be limited by the ability to adhere to the recommended protocol. Patient summaryWe investigated whether microbial DNA sequencing could improve the selection of antibiotics before kidney stone surgery in patients not known to have any bacteria in the urine on standard culture. We found that using microbe DNA to guide antibiotic choices decreased postoperative infection rate and may encourage individualized use of available antibiotics.

Endoscopic management of acute sigmoid volvulus in high risk surgical elderly patients: a randomized controlled trial

BackgroundMost patients with sigmoid volvulus are of old age with multiple comorbidities. So, the risk of surgery for those elderly patients is usually associated with increased rates of morbidity and mortality. Early intervention is required for managing sigmoid volvulus to avoid its serious complications; therefore, early endoscopic untwist of sigmoid colon can be performed followed by endoscopic fixation of sigmoid colon under sedation in this category of the patients to avoid development of high risk surgical complications following surgical fixation of sigmoid colon or sigmoidectomy after initial simple loop colostomy procedure to relieve obstruction.MethodsThis prospective randomized controlled clinical trial included all patients who developed acute sigmoid volvulus and were referred to the Zagazig University Hospital Emergency Department between December 2020 and August 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 9989/23-10-2022) and was retrospectively submitted in http://clinicaltrials.gov in November 2022 (http://clinicaltrials.gov ID: NCT05620446). Included eligible patients were simply randomized at a 1:1 ratio to “Endoscopic Group (EG)” or “Surgical Group (SG)” via drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before start of intervention.ResultsSample size included 18 patients divided into 2 equal groups. (1) Endoscopic group included 9 patients who were subjected to endoscopic untwist of sigmoid colon followed by endoscopic fixation of sigmoid colon under sedation; (2) Surgical group included 9 patients who were subjected to surgical fixation of sigmoid colon or sigmoidectomy after initial simple loop colostomy under general anesthesia. In comparison between both groups, there were statistically significant differences regarding length of hospital stay and procedure time. Unfortunately, there were no statistically significant differences regarding postoperative complications and co-morbidities. Eight patients in the endoscopy group demonstrated excellent quality of life, and one demonstrated good quality of life; unlike the surgical group, there were 3 patients with excellent quality of life, 5 patients with good quality of life, and 1 patient with poor quality of life. So there was statistically significant difference regarding quality of life between both groups. During the 9-month follow-up period, both groups demonstrated no cases of recurrence post-fixation.ConclusionEndoscopic management of acute sigmoid volvulus is effective and safe in elderly high risk surgical patients (either in managing the intestinal obstruction caused by volvulus or in definitive treatment of volvulus).

Endoscopic management of low output recurrent colonic fistula or leak after anterior resection for rectal cancer: a randomized controlled trial

BackgroundColonic anastomotic leak and fistula following anterior resection surgery for rectal cancer are associated with high mortality rates. The incidence of occurrence varies from 2 to 25% and it is difficult to accurately calculate the incidence of fistula and leak post anterior resection, as most of them are asymptomatic. Endoscopic management of fistula and leak has become the first line of management after conservative management in many gastrointestinal surgical centers with the advantages of being less invasive, shorter length of post-operative hospital stay, effective and rapid recovery in comparison to revision surgery. Effective endoscopic management for colonic fistula or leak depends on the clinical status of the patient and fistula characters (time-to-occur and size and site of defect), and device availability.MethodsThis prospective randomized controlled clinical trial included all patients who developed the manifestations of low output recurrent colonic fistula or leak after colonic anterior resection for rectal cancer at Zagazig University Hospital between (December 2020 and August 2022). Sample size was 78 patients divided into two equal groups. Endoscopic group (EG): included 39 patients who underwent endoscopic management. Surgical group (SG): included 39 patients who underwent surgical management.ResultsThe investigators randomized eligible 78 patients into two groups: 39 patients in SG and 39 patients in EG. The median size of the fistula or leak was nine (range: 7–14) mm in EG, versus ten (range: 7–12) mm in SG. Clipping and Endo-stitch device were used in 24 patients versus 15 patients, respectively, in EG while primary repair with ileostomy, and resection & anastomosis were used in 15 patients versus 24 patients, respectively, in SG. Recurrence, abdominal collection, and mortality were the post procedure’s complications with incidence of occurrence of 10.3, 7.7 and 0%, respectively, in EG versus 20.5, 20.5 and 2.6%, respectively, in SG. Excellent, good, and poor were the parameters for quality of life with incidence of occurrence of 43.6, 54.6 and 0%, respectively, in EG versus 28.2, 33.3 and 38.5%, respectively, in SG. Median hospital stay was one (range: 1–2) day in endoscopic group, and seven (range: 6–8) days in SG.ConclusionEndoscopic intervention may offer a successful modality in managing low output recurrent colonic fistula or leak after anterior resection for rectal cancer that did not respond to conservative measures in stable patients.ClinicalTrials.gov ID: NCT05659446.

MP13-07 AQUABLATION THERAPY ® VS TRANSURETHRAL RESECTION OF THE PROSTATE: 5-YEAR OUTCOMES OF THE WATER RANDOMIZED CLINICAL TRIAL FOR MEDIUM-SIZED PROSTATES

You have accessJournal of UrologyCME1 Apr 2023MP13-07 AQUABLATION THERAPY® VS TRANSURETHRAL RESECTION OF THE PROSTATE: 5-YEAR OUTCOMES OF THE WATER RANDOMIZED CLINICAL TRIAL FOR MEDIUM-SIZED PROSTATES Kussil Oumedjbeur, Ahmed Ibrahim, Imad Matta, David-Dan Nguyen, Adel Arezki, Iman Sadri, David Bouhadana, Tawfik Elsherbini, Peter Gilling, Neil Barber, Mihir Desai, Alexis E. Te, Claus G. Roehrborn, and Kevin C. Zorn Kussil OumedjbeurKussil Oumedjbeur More articles by this author , Ahmed IbrahimAhmed Ibrahim More articles by this author , Imad MattaImad Matta More articles by this author , David-Dan NguyenDavid-Dan Nguyen More articles by this author , Adel ArezkiAdel Arezki More articles by this author , Iman SadriIman Sadri More articles by this author , David BouhadanaDavid Bouhadana More articles by this author , Tawfik ElsherbiniTawfik Elsherbini More articles by this author , Peter GillingPeter Gilling More articles by this author , Neil BarberNeil Barber More articles by this author , Mihir DesaiMihir Desai More articles by this author , Alexis E. TeAlexis E. Te More articles by this author , Claus G. RoehrbornClaus G. Roehrborn More articles by this author , and Kevin C. ZornKevin C. Zorn More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003233.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The WATER trial previously introduced Aquablation® as a safe and effective TURP alternative in the management of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) for prostates <80 mL. To date, no long-term superiority endpoints have been reported for medium-sized prostates. In this subset analysis of the WATER cohort, we aim to compare the 5-year efficacy and safety of Aquablation® vs. TURP for the management of 50-80 mL prostates. METHODS: WATER is a double-blinded, multicenter and prospective randomized-controlled clinical trial for prostates 30-80 mL. 96 men with prostates 50-80 mL randomized to either Aquablation Therapy® or TURP from the initial cohort were retained for the subset analysis. Men received follow-up at 1, 3, 6 and 12 months, then annually up to 5 years. The primary efficacy endpoint was reduction of IPSS at 5-year follow-up. The primary safety endpoint was the occurrence of Clavien-Dindo postoperative complications grade 1 persistent (CD1P) and grade 2 (CD2) or higher at 6 months. Other measures included QoL, Qmax, PVR and MSHQ-EjD. RESULTS: Both study groups had comparable baseline voiding parameters and clinical demographics. Overall reduction in IPSS score was significantly higher in the Aquablation group across 5 years of follow-up (-14.1 vs. -10.8, p=0.02). Changes in QoL, Qmax and PVR were similar across groups (p>0.05). The Aquablation group displayed no changes in MSHQ-EjD score, while TURP yielded poorer questionnaire scores across all follow-ups (0.6 vs -2.1, p=0.01). The Aquablation group achieved a significantly lower rate of CD1P and CD2 or higher events at 6 months (RD=-23.1%; 95% CI [-29.9, -15.5], p=0.018). Among complications, post-operative ejaculatory dysfunction was notably lower in Aquablation® (RD=-21.9%; 95% CI [-32.5, -10.7], p=0.0005), while risk of bleeding was similar. The surgical and medical retreatment rate was also lower in Aquablation® (RD=-14.4%, 95% CI [-2.29, -30.4], p=0.015). CONCLUSIONS: Aquablation Therapy® yields better long-term efficacy and safety outcomes than TURP in the management of LUTS for prostate volumes of 50-80 mL within the WATER trial. This further supports adoption of Aquablation Therapy® over TURP for men with medium-sized prostates. Source of Funding: The trial is funded by PROCEPT BioRobotics. No funding was provided for the abstract creation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e175 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kussil Oumedjbeur More articles by this author Ahmed Ibrahim More articles by this author Imad Matta More articles by this author David-Dan Nguyen More articles by this author Adel Arezki More articles by this author Iman Sadri More articles by this author David Bouhadana More articles by this author Tawfik Elsherbini More articles by this author Peter Gilling More articles by this author Neil Barber More articles by this author Mihir Desai More articles by this author Alexis E. Te More articles by this author Claus G. Roehrborn More articles by this author Kevin C. Zorn More articles by this author Expand All Advertisement PDF downloadLoading ...

Effect of restoration material on marginal bone resorption around modified anatomic zirconia dental implants: A randomised controlled trial

ObjectiveThe primary aim of this study was to determine the effect of implant-supported porcelain-fused-to-metal (PFM) and indirect-composite-resin (ICR) fixed dental prostheses on peri-implant marginal bone resorption (MBR) in custom-made anatomic modified zirconia dental implants. MethodsA prospective randomized controlled clinical trial was conducted. Participants with premolars indicated for dental extractions were recruited into this study to receive a single-unit implant-supported fixed dental prosthesis. Modified anatomic zirconia implants with thorny-retentive surfaces were placed and loaded randomly after 3 months with either PFM or ICR crowns. Participants were recalled after 12 and 18 months for radiographic evaluation of peri-implant MBR. Implants survival was also reported. Results18 out of 20 zirconia implants were included in all study phases. 18-month survival rate was 90%. After 12 months of implant placement, the mean MBR values were 0.53 (±0.21) mm and 0.60 (±0.14) mm in the ICR group compared to 0.67 (±0.16) mm and 0.61 (±0.27) mm in the PFM group. In the 18-month follow-up, the mean MBR values were 0.61 (±0.27) and 0.67 (±0.16) mm in the ICR group compared to 0.77 (±0.29) and 0.77 (±0.27) mm in the PFM group. No significant differences were found in MBR mean values between study groups at 12- and 18-month follow-up points. ConclusionThis study showed that PFM and ICR crowns were viable zirconia-implant-supported restorations with no preference regarding MBR after 18 months. Nevertheless, long-term evaluations are warranted.

Implementation of the pre-operative rehabilitation recovery protocol and its effect on the quality of recovery after colorectal surgeries.

Background:Patients’ recovery after surgery is the major concern for all perioperative clinicians. This study aims to minimize the side effects of peri-operative surgical stress and accelerate patients’ recovery of gastrointestinal (GI) function and quality of life after colorectal surgeries, an enhanced recovery protocol based on pre-operative rehabilitation was implemented and its effect was explored.Methods:A prospective randomized controlled clinical trial was conducted, patients were recruited from January 2018 to September 2019 in this study. Patients scheduled for elective colorectal surgeries were randomly allocated to receive either standardized enhanced recovery after surgery (S-ERAS) group or enhanced recovery after surgery based on pre-operative rehabilitation (group PR-ERAS). In the group PR-ERAS, on top of recommended peri-operative strategies for enhanced recovery, formatted rehabilitation exercises pre-operatively were carried out. The primary outcome was the quality of GI recovery measured with I-FEED scoring. Secondary outcomes were quality of life scores and strength of handgrip; the incidence of adverse events till 30 days post-operatively was also analyzed.Results:A total of 240 patients were scrutinized and 213 eligible patients were enrolled, who were randomly allocated to the group S-ERAS (n = 104) and group PR-ERAS (n = 109). The percentage of normal recovery graded by I-FEED scoring was higher in group PR-ERAS (79.0% vs. 64.3%, P < 0.050). The subscores of life ability and physical well-being at post-operative 72 h were significantly improved in the group PR-ERAS using quality of recovery score (QOR-40) questionnaire (P < 0.050). The strength of hand grip post-operatively was also improved in the group PR-ERAS (P < 0.050). The incidence of bowel-related and other adverse events was similar in both groups till 30 days post-operatively (P > 0.050).Conclusions:Peri-operative rehabilitation exercise might be another benevolent factor for early recovery of GI function and life of quality after colorectal surgery. Newer, more surgery-specific rehabilitation recovery protocol merits further exploration for these patients.Trial Registration:ChiCTR.org.cn, ChiCTR-ONRC-14005096

Role of Including the Index level in Short Segment Pedicular Fixation in Traumatic Thoraco-Lumbar Fractures

Abstract Background It is generally acknowledged that short-segment pedicle screw instrumentation is the preferred surgical method for thoracolumbar fractures. However, the use of short-segment instrumentation with or without intermediate screws at the fracture level remains controversial. This review will evaluate the evidence available to date regarding the efficacy of including the fracture level in trans-pedicular screw short segment fixation, to assess clinical and radiological outcome. Objectives Our primary objective is evaluating the efficacy and outcome of including the fractured level vertebra in short segment fixation. And concerns regarding the use of pedicle screws into the fractured vertebra as to whether it is safe to insert a screw through a broken bone. Our secondary objective analyzing the importance of posterior pedicle screw fixation in unstable thoracolumbar fractures. Methods The following electronic databases will be searched from 1992 to 2018: PubMed, Google scholar search engine. Cochrane database of systematic reviews, EMBASE and science Direct, using the keywords “TLICS”, "index screw", “short segment fixation”, "Thoracolumbar spine trauma", "traumatic spine injury", "spinal cord injury", "spine trauma", "role", “reliability”.Studies will be eligible if they contain the target keywords in title or abstract, addressing our age group. Afterwards the full text of the articles will be reviewed to exclude full texts not fulfilling the criteria or deviating from the initial impression taken from the title/abstract reviewing. References/bibliography of the selected articles will be examined to evaluate potential for further research and possible inclusion in the analysis. Any differences will be sorted by discussion between study team (student, director, and co-directors). Results A total of 3010 studies were screened for eligibility , 8 studies were included in our systematic review for comparing the short segment fixation “including” the fracture level with “conventional” methods whether short or long segment fixation. Overall study population reached 512 patients. Analysis showed comparable results regarding clinical picture and radiography, showing highly statistically significant difference in favor of “including” index level in fixation in post operative kyphosis angle correction, loss of correction of kyphosis angle through follow up until 2 years and loss of correction of AVH, also statistically significant difference in rate of implant failure in favor for “including” group, and with no significant difference in operative time , blood loss and VAS for post-operative pain. Conclusion We conclude that Short segment fixation including the fracture level is a promising surgical option when it comes to thoraco-lumbar unstable fractures. In conclusion, inclusion of the fracture level into the construct offers a better kyphosis correction, in addition to fewer instrument failures, without additional complications, and with a comparable-if not better-clinical outcome, the radiologic correction achieved is maintained even at the end of 2 years and reflected in good functional outcomes. We recommend insertion of screws into pedicles of the fractured thoracolumbar vertebra when considering a short segment posterior fixation, especially in Magerl type C fractures. Large population prospective randomized controlled studies and clinical trials are recommended for more high level evidence data.

Early Rehabilitation Training Promotes Recovery of Lung Function in Patients with Congenital Heart Disease After Cardiopulmonary Bypass

This article conducts an in-depth study on the recovery of lung function in patients with congenital heart disease after cardiopulmonary bypass through early rehabilitation training, and discusses the effectiveness of early activities after cardiopulmonary bypass in children with congenital heart disease. The children with congenital heart disease who met the criteria were divided into an intervention group and a control group according to the random number table method, and prospective randomized controlled clinical trials were conducted. The control group was given routine clinical care. In addition to routine care, the experimental group increased early active intervention. The intervention content mainly includes preoperative early activity education and postoperative child vital signs to provide early activity guide. The rehabilitation was used as indicators to evaluate the postoperative recovery of the children. Data were collected at the time of discharge and 3 months after discharge, and statistics were performed using SPSS18.0 software analysis. To evaluate the effect of early activity on postoperative recovery in children with congenital heart disease, it improved the heart and lung function in children, improve their quality of life, promotes postoperative recovery of children, and provide a scientific basis for early active intervention in clinical work.

The new "cubism" graft technique in tympanoplasty: A randomized controlled trial.

ObjectivesThe aim of this prospective, randomized‐controlled study is to analyze the outcomes of a new graft technique in tympanoplasty and compare its outcomes with cartilage island graft plus extra perichondrium.MethodsA total of 44 patients with noncomplicated chronic otitis media were included in this prospective randomized‐controlled clinical trial. Patients were randomly divided into 2 double‐layer graft groups: The cartilage island graft + cubism graft (study group) and the cartilage island graft + extra perichondrium (control group). The main outcome measures of the study were the air‐bone gap (ABG), ABG gain, and graft status.ResultsGraft success rate was 100% and 95.5% in the study group and the control group, respectively. There were statistically significant differences in the postoperative first month ABG and ABG gain between study and control groups (P < .05). ABG and ABG gain showed no significant differences in the postoperative sixth month between groups (P > .05).ConclusionThis study revealed that both graft techniques have satisfactory functional and morphological results compared to preoperative findings. The use of cubism graft with cartilage island graft has significantly better auditory outcomes in short‐term and similar results in long‐term compared to double‐layered cartilage island graft with extra perichondrium. Cubism graft is a highly promising graft technique with its many advantages.Level of Evidence1b.

A comparative study to evaluate the effect of Puerarin versus simvastatin as osteoconductive material for Maxillary sinus augmentation: A prospective randomized control clinical trial

Dental implant is an effective treatment method for oral rehabilitation. Still, it has to be modified because of unfavorable environments such as excessive alveolar bone loss and sinus pneumatization. Maxillary sinus grafting is a standard procedure used to correct such unfavorable conditions in the posterior maxilla. Purpose: to assess and compare changes in height and percentage of Puerarin versus simvastatin as osteoconductive materials following sinus augmentation. Basic procedures: twenty patients with edentulous posterior maxilla were selected and equally grouped into 2 groups. Both groups underwent antral augmentation using either Puerarin on Fisiograft sponge carrier graft (group A) or combination of simvastatin and β-TCP (group B). The amount and percentage of bone graft were evaluated radiographically. Assessment occurred at period intervals 1-week and 6-month postoperatively. Data were presented as mean and standard deviation (SD) values. For non-parametric data, Mann-Whitney U test was used to compare between the two groups. Qualitative data were presented as frequencies and percentages. Fisher’s Exact test was used for comparisons between the groups. The significance level was set at P ≤ 0.05. Main finding: there was decrease in the amount and percentage of bone graft height by 2.5 mm, 19.7% (for Group A) and 3.2 mm, 22.4% (for Group B) at the end of the 6 months period without significant difference in both group (P-value = 0.054, Effect size = 0.919) and (P-value = 0.151, Effect size = 0.678), respectively. Conclusion: Puerarin and Simvastatin are clinically beneficial and safe bone grafting materials in cases of antral augmentation.

Pemetrexed-based first-line chemotherapy had particularly prominent objective response rate for advanced NSCLC: A network meta-analysis

ObjectiveThe aim of the present work was to investigate the clinical efficacy of first-line chemotherapy regimens in the treatment of advanced non-small cell lung cancer (NSCLC) through a comprehensive network meta-analysis (NMA).MethodsThe prospective randomized controlled clinical trials relevant to 10 first-line chemotherapy regimens in the treatment of advanced NSCLC were systematic electronic search in the databases of Pubmed, Embase, Cochrane Library and CNKI. The combined direct or indirect objective response rate (ORR) between each of the 10 first-line chemotherapy regimens was calculated.ResultsSeventeen prospective clinical trials of first-line chemotherapy regimens in treatment of advanced NSCLC were included in the NMA. The 10 treatment regimens including A = cisplatin + gemcitabine, B = carboplatin + gemcitabine, C = gemcitabine, D = carboplatin + paclitaxel, E = paclitaxel + gemcitabine, F = docetaxel + carboplatin, G = gemcitabine + vinorelbine, H = pemetrexed + carboplatin, I = cisplatin + pemetrexed and J = cisplatin + docetaxel were compared in the present NMA. Direct pooled results indicated that the ORR was not statistically different (P all > 0.05). However, NMA showed that the combined ORR for regimens A (OR = 1.47, 95% CI: 0.80–2.81), B (OR = 3.22, 95% CI: 1.45–6.923), D (OR = 3.30, 95% CI: 1.22–9.33), E (OR = 4.36, 95% CI: 1.64–12.82), G (OR = 3.72, 95% CI: 1.12–12.83) and I (OR = 5.80, 95% CI: 2.04–17.86) was superior to regimen C. Rank probability analysis indicated that regimen C = gemcitabine and regimen I = cisplatin + pemetrexed had the highest probability of inferior and superior treatment ORR among the 10 first-line chemotherapy regimens.ConclusionCisplatin + pemetrexed may have particularly prominent ORR for advanced NSCLC as the first-line chemotherapy regimen.

Ultra-low dose of intratecal naloxone to minimize morphine - induced adverse effects

BackgroundIntrathecal morphine is not devoid of adverse effects such as nausea, vomiting, and pruritus. Our goal was to study the efficacy of intrathecal ultra-low-dose naloxone in decreasing postoperative morphine-induced adverse effects.Patients and methodsA prospective randomized double-blind controlled clinical trial was conducted that involved 100 adult patients undergoing minor anal surgeries under spinal anesthesia. Patients were equally randomized into two groups: group B received 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine and normal saline as placebo in 2-ml volume, and group L received the same dose of bupivacaine with 0.2 mg morphine, and 5 ng/kg naloxone in the same volume. Postoperative nausea and vomiting (PONV) incidence was assessed during the first postoperative day. Both PONV and itching severity through visual analog scale for each were assessed every 2 h along the first postoperative day.ResultsThere were significant differences between groups regarding the incidence of PONV (P = 0.031). Scales of PONV were significantly higher in group B in the early 10 postoperative hours, and at the 16th-hour score. Pruritus scale was significantly higher in group B than group L at the second and fourth postoperative hours.ConclusionThe use of 5 ng/kg intrathecal naloxone along with morphine can reduce the incidence and severity of postoperative intrathecal morphine-induced nausea, vomiting, and itching.

Pulsed Radiofrequency on Thoracic Dorsal Root Ganglion Versus Thoracic Paravertebral Nerve for Chronic Postmastectomy Pain, A Randomized Trial: 6-Month Results

Pharmacologic treatment is not successful in all cases of postmastectomy pain syndrome (PMPS). Some patients continue suffering pain while taking their medications, and others cannot tolerate the side effects of antineuropathic analgesics. Radiofrequency technology has provided promising results in the management of chronic neuropathic pain. Considering that affection of intercostobrachial nerves are the main reason behind PMPS, we aimed to evaluate and compare the analgesic efficacy of pulsed radiofrequency (PRF) when delivered either on thoracic dorsal root ganglion (DRG) of intercostobrachial nerves (thoracic DRG 2, 3, and 4) or their corresponding thoracic paravertebral nerves (PVNs). Prospective randomized-controlled clinical trial. Interventional pain unit, tertiary center, university hospital. Sixty-four patients complaining of PMPS were randomized to either group DRG (n = 32) that received PRF on thoracic DRG, or group PVN (n = 32) that received PRF on thoracic PVN. The outcome variables were that the patients showed > 50% reduction in their visual analog scale (VAS) pain score; the VAS pain score and global perceived effect (GPE) was evaluated during a 6-month follow-up period. The percentage of patients who showed > 50% reduction of their VAS pain score was significantly higher in group DRG compared with group PVN, assessed at 4 and 6 months postprocedure (23/29:79.3% vs. 13/29:44.8%; P = 0.007) and (22/29:75.9% vs. 7/29:24.1%; P < 0.001), respectively, however, the 2 groups did not significantly differ at 1, 2, and 3 months postprocedure (DRG vs. PVN), (21/29: 72.4% vs. 21/29: 72.4%; P = 0.542), (24/29: 82.8% vs. 23/29: 79.9%; P = 0.778), and (24/29: 82.8% vs. 19/29: 65.5%; P = 0.136), respectively. There was a statistically significant reduction of VAS pain score at 4 and 6 months (DRG vs. PVN, mean ± standard deviation, 2.9 ± 2 vs. 3.9 ± 1.5; mean difference (95% confidence interval), 1 (0.06:1.9); P = 0.038; 3 ± 1.94 vs. 5.1 ± 1.5; mean difference (95% confidence interval), 1.9 (1:2.9); P < 0.001, respectively), however, the 2 groups did not significantly differ at 1, 2, and 3 months postprocedure. With regard to the patient's satisfaction (i.e., GPE), assessed at 3 and 6 months postprocedure, there was a significantly higher satisfaction in group DRG compared with group PVN (median [interquartile range (IQR)], 6 (5:7) vs. 3 (2:4);P < 0.001), however, the patient's satisfaction was similar between groups at 3 months postprocedure: median (IQR), 6 (4:7) vs. 6 (5:6); P = 0.327. The study follow-up period is limited to 6 months only. PRF of both the thoracic DRG and the thoracic PVN are effective treatments for PMPS; however, PRF of DRG provided a better long-term analgesic effect. Nevertheless, given the inherent risk of performing thoracic foraminal interventions and the technical difficulty of targeting thoracic DRG, we recommend that PRF of DRG should be reserved for cases that failed to gain adequate response to PRF of thoracic PVN in conjunction with medical treatment. Postmastectomy pain syndrome, radiofrequency, dorsal root ganglion, paravertebral nerve.

“Sequential multimodality stimulation” for post-stroke-hemineglect: Feasibility and outcome in a pilot randomized controlled trial

ObjectiveTo test the feasibility and efficacy of multimodality stimulation combined with motor tasking as a corrective strategy for hemineglect following right hemispheric ischemic strokes. Material and methodsA prospective randomized controlled single blinded clinical trial was conducted over eighteen months from January 2017. All patients with right hemispheric ischemic strokes were screened for hemineglect and those fulfilling criteria were recruited and randomized. Patients under the therapy group (TG) received the intervention based on a structured protocol in addition to standard physiotherapy. The control group (CG) received standard physiotherapy alone. NIHSS, mRS and Neuropsychological test scores were recorded at different time points. The primary outcome measures (neuropsychological test scores) were compared between the two groups (Student's t-test to find out the difference in outcome measures) at one and three months post-stroke. ResultsOf the 14 patients recruited, data from 12 were available for analysis, 5 patients in TG and 7 in CG. There was a trend for better hemineglect and functional outcomes in TG. ConclusionMultimodality stimulation, in addition to standard physiotherapy, is feasible and potentially results in better neurocognitive and functional recovery following right hemispheric ischemic strokes. However, larger studies are warranted to prove these preliminary observations beyond doubt.

Transplantation of autologous bone marrow-derived mesenchymal stem cells under arthroscopic surgery with microfracture versus microfracture alone for articular cartilage lesions in the knee: A multicenter prospective randomized control clinical trial.

IntroductionTo investigate the efficacy of the transplantation of autologous bone marrow-derived mesenchymal stem cells (BMSCs) under arthroscopy with microfracture (MFX) compared with microfracture alone.MethodsEleven patients with a symptomatic articular cartilage defect of the knee were included in the study. They were randomized to receive BMSCs with MFX (cell-T group, n=7) or MFX alone (control group, n=4). Clinical results were evaluated using International Knee Documentation committee (IKDC) knee evaluation questionnaires and the Knee Injury and Osteoarthritis Outcome Score (KOOS) before and 48 weeks after surgery. Quantitative and qualitative assessments of repair tissue were carried out at 48 weeks by T2 mapping of magnetic resonance images (MRIs) and the magnetic resonance observation of cartilage repair tissue (MOCART) scoring system with follow-up MRI.ResultsNo significant differences between preoperative and postoperative IKDC and KOOS were observed in the cell-T or control group. However, forty-eight weeks after surgery, the cell-T group showed a trend for a greater KOOS QOL score compared with the control group (79.4 vs. 39.1, respectively; P=0.07). The T2 value did not differ significantly between the two groups, but the mean MOCART score was significantly higher in the cell-T group than in the control group (P=0.02).ConclusionsCompared with MFX alone, BMSC transplantation with MFX resulted in better postoperative healing of the cartilage and subchondral bone as determined by the MOCART score. Clinically, BMSC transplantation with MFX gave a higher KOOS QOL score after 48 weeks.

Residents' journal review

Residents' journal review

The effect of dexmedetomidine versus propofol in traumatic brain injury: evaluation of some hemodynamic and intracranial pressure changes

BackgroundCerebral edema and increased intracranial pressure are of the major consequences of traumatic brain injury that affects the outcome. The aim of this study is to assess the efficacy of dexmedetomidine as an adjunct to conventional sedative therapy (propofol) compared to conventional sedative therapy alone in patients with traumatic brain injury, as regards its effects on hemodynamics and intracranial pressure.MethodsThis prospective randomized controlled clinical trial with 60 agitated and restless traumatic brain-injured patients was performed between May 2013 and May 2017. Patients who required mechanical ventilation, Glasgow coma scale (GCS) < 8, or hemodynamically instable were excluded. Patients were randomized into three equal groups: dexmedetomidine was infused in a dose of 0.5 μg/kg/h for 48 h in the first group, propofol 1% was infused in a dose of 4 mg/kg/h for 48 h in the second group, and dexmedetomidine was infused in a dose of 0.2 μg/kg/h and propofol was infused in a dose of 2 mg/kg/h for 48 h in the third group. ICP and CPP excursions and complications were assessed in the first 48 h.ResultsThe number of ICP and CPP excursions per day was not significantly different between the three groups. Tachycardia, bradycardia, and hypertension in the three groups were statistically insignificant. As regards hypotension, there was a statistically significant difference between the three studied groups.ConclusionDexmedetomidine or its combination with propofol is as effective as propofol alone in TBI; all alternatives are equal as regards the degree of sedation, effect on intracranial pressure, and cerebral perfusion pressure. The incidence of complications does not vary greatly between all groups.Trial registration17200257 registered 5/2013