Visual Acuity, Vitreous Hemorrhage, and Other Ocular Outcomes After Vitrectomy vs Aflibercept for Vitreous Hemorrhage Due to Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial
JAMA ophthalmology. 2021
IMPORTANCE Although there were no differences in mean visual acuity (VA) over 24 weeks after vitrectomy with panretinal photocoagulation (PRP) vs aflibercept in a randomized clinical trial among eyes with vitreous hemorrhage due to proliferative diabetic retinopathy (PDR), post hoc analyses may influence treatment choices. OBJECTIVE To compare exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to PDR. DESIGN, SETTING, AND PARTICIPANTS This post hoc analysis of a randomized clinical trial conducted at 39 DRCR Retina Network sites included adults with vision loss due to PDR-related vitreous hemorrhage for whom vitrectomy was considered. Data were collected from November 2016 to January 2020. INTERVENTIONS Random assignment to 4 monthly injections of aflibercept vs vitrectomy with PRP. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol-specific criteria. MAIN OUTCOMES AND MEASURES Visual acuity area under the curve (adjusted for baseline VA) and clearance of vitreous hemorrhage. RESULTS A total of 205 eyes were included in the analysis (115 male [56%] and 90 [44%] female participants; mean [SD] age, 57  years). Among 89 eyes with a baseline VA of 20/32 to 20/160 (47 receiving aflibercept, including 4 [9%] that had undergone vitrectomy; 42 undergoing vitrectomy, including 3 [7%] that had received aflibercept), the adjusted mean difference in VA letter score over 24 weeks between the aflibercept and vitrectomy groups was -4.3 (95% CI, -10.6 to 1.9) compared with -16.7 (95% CI, -24.4 to -9.1) among 59 eyes with baseline VA worse than 20/800 (P = .02 for interaction; 26 in the aflibercept group, including 6 [23%] that had undergone vitrectomy; 33 in the vitrectomy group, including 8 [24%] that had received aflibercept). In the full cohort, the median time to clearance of the initial vitreous hemorrhage was 36 (interquartile range [IQR], 24-52) weeks in the aflibercept group vs 4 (IQR, 4-4) weeks in the vitrectomy group (difference, 32 [95% CI, 20-32] weeks; P < .001). CONCLUSIONS AND RELEVANCE Both initial aflibercept and vitrectomy with PRP are viable treatment approaches for PDR-related vitreous hemorrhage. Although this study did not find a significant difference between groups in the primary outcome of mean VA over 24 weeks of follow-up, eyes receiving initial vitrectomy with PRP had faster recovery of vision over 24 weeks when baseline VA was worse than 20/800 and faster vitreous hemorrhage clearance. Approximately one-third of the eyes in each group received the alternative treatment (aflibercept or vitrectomy with PRP). These factors may influence treatment decisions for patients initiating therapy for PDR-related vitreous hemorrhage. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02858076.
Desmopressin effects on bleeding during functional endoscopic sinus surgery on patients with chronic rhinosinusitis
American journal of otolaryngology. 2021;42(5):103024
OBJECTIVE In this study we aimed to determine whether Desmopressin (DDAVP) can alter bleeding and improves surgeon visual field and decrease operation time or lessen use of anesthesiology medication in a clinical trial study. METHOD This study is a randomized clinical trial using the permuted block randomization method. 44 patients were enrolled in study and divided into two equal intervention-control groups. The intervention group received maximum dose of 0/2 micrograms per kg of DDAVP. In the control group, 30 min before the surgery, 100 ml of normal saline will be injected. RESULTS The amount of bleeding was 517/17 cc in control group during surgery while it was 387/72 cc in group receiving DDAVP which is significantly lower. The satisfaction of surgeon regarding suitable visual field was 6/45 in control group while it was 3/77 in DDAVP receivers which is lower. CONCLUSION It seems that intravenous DDAVP can reduce bleeding during surgery and offer an enhanced vision for surgeon during surgery but it has no potential efficacy on reduction of period of surgery and need for anesthesiology medication like remifentanil and isoflurane.
Evaluation of local tranexamic acid on septoplastic surgery quality
Journal of plastic, reconstructive & aesthetic surgery : JPRAS. 2021
BACKGROUND Even a small amount of bleeding during nose surgery can impair the surgeon's vision, prolong the duration of operation, and affect surgery quality; therefore, various techniques have been proposed to control the bleeding. The aim of this study was to compare the efficacy of the local use of tranexamic acid (TXA) in the dry field of surgery. METHOD This randomized, double-blinded, controlled trial was conducted in the operation room of Imam Reza Hospital, Tehran, Iran, from January 10, 2016 to February 8, 2017. Sixty patients with age range from 20 to 60 years and the American Society of Anesthesiologists physical status classes I candidates who require septoplasty enrolled. Patients were randomized through white and black cards to receive either syringes. Thirty patients in the intervention group received lidocaine + adrenaline + TXA and 30 patients in the control group received lidocaine + adrenaline. Bleeding volume accumulated in the suction chamber, the nasopharyngeal pack, and hemodynamic variations were measured. Surgeon's satisfaction scores and suitability of operation field were obtained from the surgeon by using the Likert scale and Boezaart grading scale, respectively. RESULTS The intervention group had a higher score of surgeon satisfaction [4.1 vs 3.16 in the control group (P = 0.001)] and fewer hemodynamic variations. The mean bleeding volume in the intervention was 187.23 ± 54.61 mL and in the control group was 341.22 ± 49.17 mL (P = 0.001). The mean Boezaart score (suitability of operation field) in the intervention group was 1.8 (score range: 1-3) and in the control group was 2.53 (score range: 2-4) and it was statistically significant (P = 0.001). CONCLUSION The local use of TXA + lidocaine + adrenaline is associated with reduced bleeding, greater surgeon satisfaction, reduced need for Karpol injection, and better hemodynamic stability.
Intravitreal bevacizumab (IVB) versus IVB in combination with pars plana vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy: a randomized clinical trial
International journal of retina and vitreous. 2021;7(1):35
BACKGROUND The main purpose of this study is to compare the vitreous hemorrhage (VH) score reduction and visual acuity outcomes in patients with VH secondary to proliferative diabetic retinopathy (PDR) treated with intravitreal injections of bevacizumab (IVB) versus IVB and pars plana vitrectomy (IVB and PPV). METHODS Patients with VH secondary to PDR were randomized into 2 groups: in Group A, patients were treated with a total of 3 IVB (1.5 mg/0.06 ml) at 8-week intervals; and in Group B, patients received a single IVB (1.5 mg/0.06 ml) and, 7 days later, underwent PPV. Patients received an ophthalmic evaluation that included best-corrected visual acuity (BCVA), indirect ophthalmoscopy, and mode B echography at weeks 8, 16 and 24. VH was classified according to the Diabetic Retinopathy Vitrectomy Study classification as grade 1, 2 or 3. Change in VH score was the primary outcome measure and change in BCVA was the secondary outcome. RESULTS Seventy-three eyes of 66 patients were randomized and 70 eyes completed the 24-week follow-up visit. Mean VH score reduction (± SEM) of 0.4571 ± 0.0283 (p = 0.0014), 1.3429 ± 0.0393 (p < 0.0001) and 1.8286 ± 0.0438 (p < 0.001) was observed in Group A at 8, 16 and 24 weeks after treatment, respectively (Table 2; Fig. 2). In Group B, the reduction of VH score (± SEM) was 2.2571 ± 0.0720 (p = 0.0014), 2.2857 ± 0.0606 (p < 0.0001) and 2.2286 ± 0.0726 (p < 0.001) at 8, 16 and 24 weeks after treatment, respectively. Group comparison revealed a significantly greater reduction in mean VH score in Group B at 8 and 16 weeks after treatment (p < 0.0001). However, at 24 weeks this difference was no longer statistically significant (p = 0.1854). In Group A, mean (± SEM) BCVA showed an improvement of 0.00285 ± 0.0004 (p = 0.971), 0.5371 ± 0.0072 (p < 0.0001), 0.8143 ± 0.0001 (p < 0.0001) and 0.8543 ± 0.0008 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. In Group B, mean (± SEM) BCVA showed an improvement of 0.3657 ± 0.0507 (p = 0.0002), 0.8857 ± 0.0385 (p < 0.0001), 0.9457 ± 0.0499 (p < 0.0001) and 0.9629 ± 0477 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. No significant difference in BCVA improvement was observed between groups at 24 weeks after treatment. CONCLUSION PPV with preoperative IVB is associated with more rapid clearance of VH and improvement in BCVA than IVB injections alone. However, after 24 weeks of follow-up, the reduction in VH score and BCVA were similar between both treatment strategies. Trial Registration The project is registered in Plataforma Brasil with CAAE number 927354.7.0000.5440 and was approved by the Ethics Committee of the Clinics Hospital of Ribeirao Preto Medicine School of São Paulo University-Ribeirão Preto, São Paulo, Brazil (appreciation number 3.053.397 gave the approval).
[The efficacy of hemostatic powder for chronic rhinosinusitis in endoscopic sinus surgery: a prospective, randomised, controlled and single blinded clinical trial]
Zhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery. 2021;56(2):144-149
Objective: To study the efficacy and patient comfort of absorbable hemostatic powder after endoscopic sinus surgery (ESS). Methods: A total of 21 (17 males, 4 females) patients with an average age of 42(ranging from 18 to 65) underwent bilateral ESS for chronic rhinosinusitis(CRS) in Beijing Tongren Hospital, Capital Medical University between October 2015 and July 2019 were enrolled to compare the effect of absorbable hemostasis powder with Nasopore using an intrapatient control design. A randomized controlled trial was conducted in the left and right nasal cavities of the same patient. If hemostatic powder was applied in the experiment nasal cavity, the Nasopore was applied in the control nasal cavity. The mean preoperative sinus computed tomography (CT) score was 6.25. All patients competed for symptom diaries using a visual analog scale (VAS, score out of 10) at baseline, through 1, 7, 14 and 30 days. Outcomes including bleeding, facial pain, nasal obstruction, nasal discharges using VAS were recorded separately for both sides. Postoperative endoscopic scores were also investigated. SPSS 22 and Graphpad prism 8.0 statistical softwares were used for the analysis. Paired t-test or nonparametric test was used between the test side and the control side. The difference was statistically significant (P<0.05). Results: The bleeding score and total nasal symptom VAS scores at postoperative days (POD) 1, 7, 14 and 30 were not significantly different(t=1.341, 0.552, 0.631, 0.158, all P>0.05;t=0.944, 1.471, 1.612, 2.251, all P>0.05). There was no significant difference between absorbable hemostasis powder and Nasopore side on POD 1, 7, 14 and 30 in terms of each nasal symptom VAS scores(all P>0.05). On POD 1, 7 and 14, the packing material degeneration scores of the absorbable hemostasis powder side were significantly lower than those of the Nasopore side [(1.33±0.21)vs(2.00±0.00),(0.38±0.18) vs (1.95±0.22), 0 vs (1.80±0.13), all P<0.01]. There were significant differences between absorbable hemostasis powder and Nasopore side on POD 1, 7, 14 and 30 in terms of endoscopic scores (edema, crusting, discharges, scar, polyps and material degeneration, t=3.07, 7.00, 6.41, 2.69, all P<0.05). Conclusions: The absorbable hemostasis powder and Nasopore has similar postoperative hemostasis effect. The absorbable hemostasis powder is rapidly cleared and without negative effects on mucosal wound healing 14 days postoperatively.
A Clinical Study of Platelet-Rich Fibrin Combined With Autologous High-Density Fat Transplantation in Augmentation Rhinoplasty
Ear, nose, & throat journal. 2021;:1455613211016902
OBJECTIVE This study was designed to analyze the clinical effect of autologous fat-granule transplantation in augmentation rhinoplasty and explore methods to improve the fat retention rate. METHODS A total of 70 enrolled patients were randomly divided into 2 groups: the platelet-rich fibrin (PRF) combined with high-density fat transplantation group (combined group) and the conventional fat-granule transplantation group (control group; n = 35 in each group). In the combined group, an appropriate amount of autologous fat was extracted and centrifuged, and the lower layer of high-density fat was taken and mixed with PRF isolated from whole blood for autotransplantation. In the control group, only fat was extracted and centrifuged for transplantation. The patients were followed up with for more than one year to observe the short- and long-term effects, complications, safety, and patient satisfaction. RESULTS Six months after the operation, the nasal shape was stable, the contour was higher and more stereoscopic than before, the average increase of nasal height was 3.0 mm in the combined group and 2.0 mm in the control group. No complications, such as fat embolism, infection, or necrosis occurred during the 1-year follow-up. The satisfaction rate between the 2 groups has statistical significance (P < .05). CONCLUSION Overall, PRF combined with autologous high-density fat transplantation is simple to perform, has a significantly increased fat-retention rate than the control group, and has stable long-term effects without obvious adverse reactions. A sufficient amount of fat and PRF transplantation can achieve a good orthopedic effect. Thus, this method can be widely used in clinical augmentation rhinoplasty.
Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis
American journal of rhinology & allergy. 2021;:1945892421989155
BACKGROUND Previous studies and meta analyses have led to incongruent and incomplete results respectively when total intravenous anesthesia (TIVA) and inhalational anesthesia (IA) are compared in endoscopic sinus surgeries in regards to intraoperative bleeding and visibility. OBJECTIVE To perform a more comprehensive meta-analysis on randomized controlled trial (RCTs) comparing TIVA with IA in endoscopic sinus surgery to evaluate their effects on intraoperative bleeding and visibility. METHODS A systematic review and meta-analysis of studies comparing TIVA and IA in endoscopic sinus surgery for chronic rhinosinusitis was completed in May 2020. Utilizing databases, articles were systematically screened for analysis and 19 studies met our inclusion criteria. The primary outcome included intraoperative visibility scores combining Boezaart, Wormald and Visual Analogue Scale (VAS). Secondary outcomes included rate of blood loss (mL/kg/min), estimated total blood loss (mL), Boezaart, Wormald scores, VAS, heart rate, and mean arterial pressure (MAP). RESULTS 19 RCTs with 1,010 patients were analyzed. TIVA had a significantly lower intraoperative bleeding score indicating better endoscopic visibility (Boezaart, VAS, and Wormald) than IA (-0.514, p = 0.020). IA had a significantly higher average rate of blood loss than TIVA by 0.563 mL/kg/min (p = 0.016). Estimated total blood loss was significantly lower in TIVA than IA (-0.853 mL, p = 0.002). There were no significant differences between TIVA and IA in the mean heart rate (-0.225, p = 0.63) and MAP values (-0.126, p = 0.634). The subgroup analyses revealed no significant difference between TIVA and IA when remifentanil was not utilized and whenever desflurane was the IA agent. CONCLUSION TIVA seemed to have superior intraoperative visibility scores and blood loss during endoscopic sinus surgery when compared to IA. However, the results are not consistent when stratifying the results based on the use of remifentanil and different inhaled anesthetics. Therefore, the conclusion cannot be made that one approach is superior to the other.
To evaluate the role of Feracrylum (1%) as hemostatic agent in Tonsillectomy
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India. 2021;73(2):240-245
Tonsillectomy is a common procedure performed globally. It is associated with morbidities like hemorrhage and pain. Various methods are employed to reduce them. The present study is aimed to evaluate the role of Feracrylum (1%) in traditional cold steel tonsillectomy and to measure the outcomes in terms of intra-operative bleed, intra-operative time and post operative pain and recovery. A prospective study was conducted in Department of ENT, ESI Medical College, Kalburgi Karnataka, India, for a period of two years between January 2019 to December 2020 In this study, a total of 60 patients were involved and divided them into two groups after fulfilling the inclusion and exclusion criteria. Thirty patients each undergoing tonsillectomy with the use of Feracrylum considered as Group I and without the use of Feracrylum in the tonsillar fossae considered as Group II. The study has been approved by Ethics committee and informed consent was obtained from all the study subjects. The amount of blood loss is calculated. Post operative pain based on VAS (Visual Analogue Scale) is assessed in both the groups. Assessment of recovery in days is estimated in both groups by reduced pain, gaining normal activity and normal food intake. In this study, intra-operative time in group I was 19.83 ± 3.93 min and in group II 27.16 ± 3.35 min (P < 0.001). The intra-operative blood loss in group I was 26.67 ± 4.81 ml and in group II 44.70 ± 7.59 ml (P < 0.001). Patients recovered from pain, resumed normal activity and food intake within 2-3 days in Group I and in contrast it took about 3-5 days on an average in group II. In this study, majority of the patients experienced mild pain in Group I when Feracrylum was used during hemostasis. In our study, the time taken by the patients to recover from pain, resume their normal activity and also with regard to normal food intake was rapid. On an average of 2-3 days was seen in Group I. Group II patients required 3-5 days to recover from pain and resuming normal activity and food intake. The P value of < 0.001 was highly significant. Our study has stressed that use of Feracrylum in cold steel tonsillectomy is relatively safe. Its use is associated with a significant decrease in surgical time and blood loss. Rapid recovery makes it favourable to be used in cold steel tonsillectomy.
Efficacy of topical application of autologous platelet-rich plasma in adult tonsillectomy patients: a randomised control study
The Journal of laryngology and otology. 2021;:1-6
OBJECTIVE Tonsillectomy is a painful surgery performed in cases of recurrent tonsillitis. Application of platelet-rich plasma to diminish the pain and morbidity post-tonsillectomy is gaining importance. This study evaluated post-operative pain and morbidity after autologous platelet-rich plasma application on the tonsil beds during tonsillectomy. METHOD Participants were randomised into group 1 (n = 28, peri-operative platelet-rich plasma intervention) and group 2 (n = 28, control). Post-tonsillectomy, patients were assessed (day 0, 1, 2, 3, 7 and 14) for pain, healing and time taken to return to normal activity. Data were analysed by independent t-test and chi-square test with p ≤ 0.05 as the significance level. RESULTS A significant decrease in the mean pain score up to day 7 (p < 0.05) and tonsillar fossae healing on days 2 and 3 (p < 0.05) post-tonsillectomy was noted. The majority of the patients returned to their routine activities after a week post-tonsillectomy. CONCLUSION Platelet-rich plasma application was effective in accentuating healing and reducing post-tonsillectomy pain and morbidity.
Efficacy of Platelet Rich Fibrin in Myringoplasty
Pakistan journal of medical sciences. 2021;37(1):212-216
OBJECTIVE To determine the efficacy of usage of topical autologous platelet rich fibrin (PRF) in improving outcomes of myringoplasty regarding graft uptake and hearing improvement. METHODS This study was conducted in the ENT department of Holy Family Hospital, Rawalpindi, over a period of six months from August 2019 to January 2020. It was designed as a prospective single blinded randomized controlled trial. The study involved a total of 50 participants in whom myringoplasty was done through post auricular approach using underlay technique. In 25 patients topical drops of PRF were used. Outcomes were compared after three months with the control group (n=25), who underwent myringoplasty without PRF. RESULTS After three months follow-up, graft uptake was reported 78% and 52% in cases and controls, respectively (P=0.070). Mean hearing improvement was 18 dB and 6 dB in cases and controls, respectively (P=0.014). Postoperative infection occurred in 8% of the cases, and in 32% controls (P=0.037). CONCLUSION Topical use of Platelet-Rich Fibrin during myringoplasty results in improved graft uptake. Hence, resulting in much improved hearing, significant reduction in infection rates and decrease in perforation sizes.