Division of Fasciocutaneous Pedicled Flaps-Is It Time to Change Practice?: A Prospective Randomized Controlled Trial.

INTRODUCTION: The study was carried out to evaluate the safety of early division of the pedicled flaps and to identify the optimum day of division. METHODS: This prospective, parallel arm, open-label, noninferiority, randomized controlled trial was carried out from January 2019 to July 2020. All patients (age, ≥5 years) undergoing reconstructive procedures using pedicled flaps were randomized in 1:1 ratio to receive either early division or conventional division protocol. In the early-division group, the flap perfusion, if satisfactory on day 8 by clinical and thermographic methods, a clamp was applied on the pedicle. The clamp was gradually tightened to produce controlled delay, and perfusion assessment was repeated after complete tightening. If satisfactory, the flaps were divided. Primary endpoints were flap at 24 hours after division, day of division, and day of complete inset of the flap. Secondary end points included perfusion of the flap on day 8, morbidity parameters (wound infection/suture dehiscence, need for secondary surgery and donor site morbidity), quality of life, and function scores. RESULTS: Thirty-five patients were included in each group. The 2 groups were similar in terms of various demographic, clinicopathological variables, defect and flap characteristics. The flap survival rate was similar (P = 0.31) between the early (34/35) and standard (35/35) division groups. The early-division group had a significantly early mean day of flap division (mean difference of 12.74 days; P < 0.00001) and complete flap inset (mean difference of 12.09 days; P < 0.00001). All flaps had satisfactory perfusion on day 8. The wound infection rate was 1.33 times significantly higher in the conventional group (P = 0.033). There was a higher incidence of donor site morbidity (9% vs 0%) in the conventional group when compared with the early division group. The quality of life and function scores at 3 weeks (mean difference 2.37; P < 0.001) and 6 weeks (mean difference 3.76; P < 0.001) and adjacent joint stiffness were significantly higher in the early division group when compared with conventional group. CONCLUSIONS: The pedicled flaps can be divided significantly early at an average duration of 10 to 11 days after flap inset with increased patient satisfaction rate and with a reduced postoperative morbidity. The authors have included a diversity of pedicled flaps used in different anatomic locations. By using stratified block randomization, we could ensure that the distribution was similar between the 2 groups, thus minimizing the heterogeneity in the analysis. This could also potentially indicate the usefulness of the controlled delay technique, irrespective of the anatomic location and type of the flap.

Ashwagandha (Withania somnifera) and Shunthi (Zingiber officinale) in mild and moderate COVID-19: An open-label randomized controlled exploratory trial.

BACKGROUND: Ayurveda interventions have been used for prophylaxis and care during the COVID-19 pandemic in India and have shown promising results in promoting early clinical recovery from COVID-19. OBJECTIVE: To assess the efficacy and safety of Ashwagandha [Withania somnifera (L.) Dunal] tablet and Shunthi (Zingiber officinale Roscoe) capsule in mild and moderate COVID-19 compared to conventional standard care. METHODS: A randomized controlled exploratory trial was conducted at a designated COVID-19 care center in India with 60 participants having mild or moderate COVID-19. Ashwagandha, two tablets (250 mg each), and Shunthi, two capsules (500 mg each) twice daily for 15 days, were given orally to the participants in the Ayurveda group (AG) and the control group (CG) received conventional standard care. The outcome measures included clinical recovery rate, the proportion of participants with negative RT-PCR assay for COVID-19 on day 7 and day 15, mean time to attain clinical recovery, change in pro-inflammatory markers, serum IgG for COVID-19, HRCT chest findings, disease progression and incidence of adverse events (AE). RESULTS: A total of 60 participants were enrolled, and the data of 48 participants (AG = 25 and CG = 23) were considered for the statistical analysis. The mean time for clinical recovery was reduced by almost 50 % in the AG (6.9 days) compared to CG (13.0 days) (p < 0.001). The proportion of participants who attained viral clearance in AG was 76.0 % compared to 60.8 % in the CG (RR= 1.24, 95 % CI: 0.841, 1.851, p-value = 0.270). Changes in the pro-inflammatory markers, serum IgG for COVID-19, and HRCT chest findings were comparable in both groups, and no AE or disease progression was reported. CONCLUSIONS: The Ayurveda interventions, Ashwagandha and Shunthi, can effectively reduce the duration of clinical recovery and improve time for viral clearance in mild and moderate COVID-19. These interventions were observed to be safe and well-tolerated during the duration of the trial. TRIAL REGISTRATION: Clinical Trial Registry of India - CTRI/2020/08/027224.

AYUSH-64 as an adjunct to standard care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India.

OBJECTIVE: To determine the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in mild to moderate COVID-19. DESIGN SETTING, AND INTERVENTIONS: This open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India in 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone. MAIN OUTCOME MEASURES: Proportion of participants who attained clinical recovery on day 7, 15, 23 and 30, proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point, change in pro-inflammatory markers, metabolic functions, HRCT chest (CO-RADS category) and incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE). RESULTS: Out of 80 participants, 74 (37 in each group) contributed to the final analysis. Significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. Mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG. CONCLUSIONS: AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

Bipolar versus monopolar transurethral resection of prostate: randomized controlled study.

BACKGROUND AND PURPOSE: Transurethral resection of prostate (TURP) using bipolar electrocautery and physiologic saline is a new technical advancement in the field of surgical management of benign prostatic hyperplasia. The purpose of this study was to assess the efficacy and safety of this new technique and to compare the results with those of conventional monopolar TURP. PATIENTS AND METHODS: This study included 60 patients who were randomized 1:1 to bipolar (group 1) or monopolar (group 2) TURP. Bipolar TURP was performed with the Vista CTR resectoscope and generator (ACMI Corp.). Preoperatively, patients were assessed by symptom score, uroflow, and transrectal sonography, and the two groups were comparable with regard to these measures and age. The preoperative and postoperative parameters studied included resection time, amount of tissue resected, irrigant amount, blood loss, fluid absorption, and change in serum sodium and hemoglobin. Postoperatively, patients were assessed for symptoms, symptom score, and uroflow rate at 1 and 3 months. RESULTS: There was no difference in resected tissue amount, irrigant amount, fluid absorption, duration and amount of postoperative irrigation, or fall in hemoglobin. The mean resection rate was 0.61 g/min in group 1 and 0.74 g/min in group 2. Serum Na dropped by 4.6 Eq/L in group 2, whereas it fell only 1.2 mEq/L in group 1 (P < 0.001). Improvement in symptom and QoL scores and Q(max) were similar in the two groups. Postoperative dysuria was less common with bipolar resection. CONCLUSION: Bipolar resection of the prostate is as effective as monopolar TURP. Moreover, it does not lead to any change in serum Na and causes less postoperative dysuria.

Serum p53 and bladder cancer: can serum p53 be used as a tumor marker?

The aim of this study was to find the correlation between serum p53 and carcinoma of the bladder and to investigate whether serum p53 protein can be used as a tumor marker for p53 gene alteration. The study included patients with carcinoma of the bladder and controls. Serum p53 protein estimation was done with an ELISA kit. There were 23 patients with superficial and 17 with invasive carcinoma. The median serum p53 was 31.5 U/ml in superficial and 41 U/ml in invasive cancer. This was significantly higher than the mean value (16.4 U/ml) of controls. Serum p53 rises in patients with carcinoma of the bladder and correlates with the grade of the disease . It can therefore be used as a tumor marker for bladder cancer.

Filarial chyluria: long-term experience of a university hospital in India.

BACKGROUND: Filariasis is an endemic problem in various Indian states. We evaluated the results of long-term follow up (10-20 years) of patients with filarial chyluria. METHODS: We conducted a retrospective analysis of 160 patients treated for filarial chyluria who presented to the Banaras Hindu University Hospital from 1982 to 1992. Eighty-four patients (52.5%) were treated using diethylcarbamazine (DEC) and a fat restricted diet and 76 patients (47.5%) underwent surgery. To examine the long-term effects of filarial chyluria we analysed data on post-treatment recurrence, weight gain, dietary freedom, chyluria free period and a number of other associated factors. RESULTS: Previous history of filariasis or its complication was documented in 19% of patients. In 71% of cases, cystoscopy showed that chylous efflux was predominant in the left ureteric orifice. The long-term remission rate was 62% in the conservatively managed group (DEC + fat restricted diet), whereas 90% of patients in the operated group were cured. Postoperative recurrence rate was 10%. There was more weight gain and dietary freedom along with a longer chyluria free period in the operated group relative to the conservatively managed group. CONCLUSIONS: Definitive surgical ablation of lymphatic urinary fistula is better than conservative medical management because it has a higher success rate, more dietary freedom and, therefore, better patient acceptability.