Post COVID-19 syndrome and new onset diseases: A prospective observational study.

Introduction: The National Institute of Health and Care Excellence (NICE) has defined the terms, 'acute coronavirus disease 2019' (COVID-19), 'ongoing symptomatic COVID-19' and 'post-COVID-19 syndrome', with the latter two described as having persistent symptoms after the onset of COVID-19 symptoms for 4-12 weeks and >12 weeks, respectively. Persistent symptoms can either be due to the after-effects of COVID-19 or new-onset diseases after acute COVID-19. All symptoms observed beyond 4 weeks after the onset of COVID-19 need not be present at the time of onset. Previous studies on persistent post-COVID-19 symptoms have not mentioned new-onset diseases after acute COVID-19, and only a select few studies have discussed such new-onset symptoms. Methods: Ninety-five patients who attended the post-COVID-19 clinic completed the requisite follow-up till 16 weeks after COVID-19 symptom onset. Data was recorded on a predesigned proforma. Necessary investigations were conducted to rule out any other cause of persistent symptoms. Results: Fatigue (62.1%), breathlessness (50.5%) and cough (27.4%) were the most common symptoms present beyond 4 weeks after the onset of COVID-19 symptoms. Forty-nine (51.57%) patients developed post-COVID-19 syndrome - their severity of symptoms (odds ratio [OR] 17.77) and longer duration of hospital stay (OR 1.095) during acute disease were significantly associated with the development of post-COVID-19 syndrome. During follow-up, 25 patients developed new-onset symptoms, such as diabetes mellitus, hypertension and idiopathic tachycardia. Conclusion: Patients can have persistent symptoms, new-onset symptoms and new-onset diseases after recovery from acute COVID-19.

Acute infusion effects in relapsing multiple sclerosis patients receiving alemtuzumab under a modified prophylaxis regimen.

BACKGROUND: Use of alemtuzumab in relapsing multiple sclerosis (RMS) is limited by safety concerns, notably risk of rare, serious vascular events. Along with other vital sign (VS) changes, acute increase in systolic blood pressure (SBP) is monitored as a marker of vascular risk. Peri-infusion prophylaxis is used to manage clinical risk by moderating cytokine release; protocols are not fully specified and vary across sites. Here, we report a modified prophylaxis regimen developed at Maritime Neurology. This single-center observational cohort study (NCT04633967) aimed to examine acute responses (VS events and infusion-associated reactions) in RMS patients receiving alemtuzumab infusion under this regimen. In a post hoc analysis, we examined incidence of acute SBP increase at this clinic versus the Bayshore network of Canadian infusion centers, where a standard prophylaxis regimen is used. METHODS: Alemtuzumab was infused on 5 consecutive days (Course 1; n = 29) and 3 consecutive days one year later (Course 2; n = 28). In addition to intravenous methylprednisolone 500mg on each infusion day, patients received daily prophylactic treatment with oral prednisone 50mg from 5 days before to 5 days after treatment (infusion days excepted) and oral H1 and H2 antihistaminics from 7 days before to 7 days after treatment. Excursions in SBP and other VS were relative to prespecified ranges; persistent excursions were those for which two sequential measurements were outside these ranges. In comparing VS events at Maritime Neurology and the Bayshore centers, acute SBP increase was defined as ≥20 mmHg increase in mean SBP, or any SBP reading ≥20% over patient's pre-course baseline. RESULTS: Mean (SD) VS were within range at pre-course and all other daily baselines. VS changes, including persistent excursions, were generally subclinical; all infusion-associated reactions were mild. One patient discontinued treatment after Course 1 due to immune thrombocytopenia purpura. Acute SBP increase occurred in 11/28 (39%) Maritime Neurology versus 367/610 (60%) Bayshore (p = 0.028). CONCLUSION: The modified peri-infusion prophylaxis regimen was well tolerated and may reduce incidence of acute SBP increase. FUNDING: This project was funded by Sanofi, Canada.

Factors associated with mortality among moderate and severe patients with COVID-19 in India: a secondary analysis of a randomised controlled trial.

OBJECTIVE: Large data on the clinical characteristics and outcome of COVID-19 in the Indian population are scarce. We analysed the factors associated with mortality in a cohort of moderately and severely ill patients with COVID-19 enrolled in a randomised trial on convalescent plasma. DESIGN: Secondary analysis of data from a Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease. SETTING: 39 public and private hospitals across India during the study period from 22 April to 14 July 2020. PARTICIPANTS: Of the 464 patients recruited, two were lost to follow-up, nine withdrew consent and two patients did not receive the intervention after randomisation. The cohort of 451 participants with known outcome at 28 days was analysed. PRIMARY OUTCOME MEASURE: Factors associated with all-cause mortality at 28 days after enrolment. RESULTS: The mean (SD) age was 51±12.4 years; 76.7% were males. Admission Sequential Organ Failure Assessment score was 2.4±1.1. Non-invasive ventilation, invasive ventilation and vasopressor therapy were required in 98.9%, 8.4% and 4.0%, respectively. The 28-day mortality was 14.4%. Median time from symptom onset to hospital admission was similar in survivors (4 days; IQR 3-7) and non-survivors (4 days; IQR 3-6). Patients with two or more comorbidities had 2.25 (95% CI 1.18 to 4.29, p=0.014) times risk of death. When compared with survivors, admission interleukin-6 levels were higher (p<0.001) in non-survivors and increased further on day 3. On multivariable Fine and Gray model, severity of illness (subdistribution HR 1.22, 95% CI 1.11 to 1.35, p<0.001), PaO2/FiO2 ratio <100 (3.47, 1.64-7.37, p=0.001), neutrophil lymphocyte ratio >10 (9.97, 3.65-27.13, p<0.001), D-dimer >1.0 mg/L (2.50, 1.14-5.48, p=0.022), ferritin ≥500 ng/mL (2.67, 1.44-4.96, p=0.002) and lactate dehydrogenase ≥450 IU/L (2.96, 1.60-5.45, p=0.001) were significantly associated with death. CONCLUSION: In this cohort of moderately and severely ill patients with COVID-19, severity of illness, underlying comorbidities and elevated levels of inflammatory markers were significantly associated with death. TRIAL REGISTRATION NUMBER: CTRI/2020/04/024775.

A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: a pilot trial.

OBJECTIVE: Protocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to determine whether adults managed with both PS + DI have a shorter duration of MV than patients managed with PS alone. DESIGN: Prospective randomized, concealed, unblinded, multicenter, pilot trial. SETTING: Three university-affiliated medical-surgical ICUs. PATIENTS: Sixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions. INTERVENTIONS: Patients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3-4. The PS + DI group also had infusions interrupted daily until the patients awoke. MEASUREMENTS AND MAIN RESULTS: Diagnosis, age [mean +/- SD] (53 +/- 18.3 vs. 62.1 +/- 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 +/- 8.4 vs. 26.6 +/- 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3-4) in 59% of 9,611 measurements, and within an acceptable range (2-5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo). CONCLUSION: This pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes.

Prolene (mesh) bulbourethral sling in male incontinence.

OBJECTIVE: We present our preliminary results of bulbar urethral sling (single bolster) in treatment of postprostatectomy urinary incontinence (PPUI). MATERIALS AND METHODS: From May 2003 to June 2005, six patients with postprostatectomy urinary incontinence (transurethral resection of prostate in five patients and after open prostatectomy in one patient) underwent prolene mesh bulbar urethral sling surgery. Preoperative evaluation included physical examination, neurological assessment, stress cystogram and urethrocystoscopy. Urodynamic evaluation was done in all patients for abdominal leak point pressure and ruling out bladder pathology. RESULTS: Urodynamic studies did not demonstrate bladder instability in any patient. Mean abdominal leak point pressure was 43cm of water (range 26-80 cm of water). Mean duration of hospital stay was 3.2 days. Follow-up ranged from 6-22 months. Four patients out of six patients were completely dry till their last follow-up. One patient developed mild stress incontinence after one year of the surgery and required use of one to two pads per day. Mean pad use after surgery was 0.6 pads per day in comparison to mean pad usage of 6.4 pads per day preoperatively. One patient was over-continent after the procedure and required clean intermittent catheterization till last follow-up (six months). Mean cost of the procedure was $ 350+15. CONCLUSION: Prolene bulbar urethral sling (single bolster) is an economically effective option in patients with postprostatectomy urinary incontinence.

Comparison of endopyelotomy and laparoscopic pyeloplasty for poorly functioning kidneys with ureteropelvic junction obstruction.

UNLABELLED: Endopyelotomy and laparoscopic pyeloplasty are established procedures for ureteropelvic junction obstruction (UPJO) and historically a high failure rate has been observed in poorly functioning units with UPJ obstruction. The aim of this study is to compare the results of laparoscopic pyeloplasty with endopyelotomy in poorly functioning renal units, i.e., GFR under 25 ml/min. MATERIALS AND METHODS: Retrospective analysis of all the patients who underwent either laparoscopic pyeloplasty or endopyelotomy for ureteropelvic junction obstruction in poorly functioning units between January 1998 and June 2005 was done. Follow-up renal scans, done at three, six, 12 months and yearly thereafter, were studied. Success was defined as symptomatic relief and/ or improvement in function (10% over baseline) in renal scan. RESULTS: There were 23 patients in the endopyelotomy group and 15 patients in the laparoscopic pyeloplasty group with mean age of 25.3 years (9-53) and 26 years (10-44), respectively. Mean pelvic volume was 41.2 8cc +/- 9.5 and 39.1cc +/- 9.85 in the endopyelotomy group and laparoscopic pyeloplasty group, respectively. Mean preoperative GFR was 17.4 +/- 5.7 ml/min and 21 +/- 4.5 ml/min in the endopyelotomy group and laparoscopic pyeloplasty group, respectively and mean postoperative GFR was 21 +/- 3.5 ml/min and 22 +/- 3.9 ml/min, respectively. Eighteen and 11 patients were symptomatic in ethe ndopyelotomy group and laparoscopic pyeloplasty group, respectively while symptomatic improvement was seen in 14 and 11 patients, respectively. Mean follow-up was 12 months in the laparoscopy group and 28 months in the endopyelotomy group. Success rate was better for laparoscopic surgery group (15/15 = 100%) than for endopyelotomy (18/23 = 78.26%). CONCLUSIONS: Though the improvement in renal function is less in patients with UPJO with poorly functioning kidneys undergoing endopyelotomy or laparoscopic pyeloplasty, laparoscopic pyeloplasty gives better results in the form of symptomatic relief; however, renal function remains stable whichever the approach chosen.

Hem-o-lok clips for vascular control during laparoscopic ablative nephrectomy: a single-center experience.

BACKGROUND AND PURPOSE: Vascular control is an important step in laparoscopic nephrectomy. The various options are titanium clips, Hem-o-lok clips (Weck Closure Systems, Research Triangle Park, NC), T-knot, and stapling devices. We report our experience with the use of Hem-o-lok clips. PATIENTS AND METHODS: From January 2001 to June 2004, 246 laparoscopic ablative nephrectomies (178 simple; 68 radical) were performed at our institute for benign and malignant conditions. All patients (mean age 46.76+/-26.31 years) were evaluated by detailed history and physical examination and laboratory investigations and underwent standard transperitoneal (N=204) or retroperitoneal (N=42) nephrectomy. Venous and arterial control was obtained using Hem-o-lock clips. In cases where the clips could not be applied directly on the renal vein, various maneuvers were employed to secure the occlusion. The features compared were the number of clips used, safety, cost, and requirement for blood transfusion. RESULTS: Conversion to an open procedure was required in 36 patients (28 in the transperitoneal group and 8 in the retroperitoneal group). The mean operative time was 280+/-35 minutes and 235+/-44 minutes in the retroperitoneal and transperitoneal groups, respectively. In all cases, arterial and venous control was achieved by application of two Hem-o-lok clips on the patient side. Blood transfusion was required by 7.2% of the patients (right-side nephrectomy 4.6%; left side nephrectomy 2.6%), but none was attributable to clip-related complication. The mean postoperative hospital stay was 3.4 days. CONCLUSION: Hem-o-lok clips are a reliable and cost-effective means of achieving vascular control during laparoscopic nephrectomy.

Inferior vena cava in urology: importance of developmental abnormalities in clinical practice.

Anomalies of the inferior vena cava (IVC) have been known since 1793, when Abernethy first described a congenital, mesocaval shunt and azygous continuation of the IVC in a 10-month-old infant with polysplenia and dextrocardia. The IVC is formed by a complex process of embryogenesis during the sixth to tenth week of gestation. It forms from continuous appearance and regression of the three paired veins: posterior cardinal, subcardinal, and supracardinal. Improper completion of the developmental process may result in at least 14 anatomic anomalies, out of which the following four are usually encountered in clinical practice: duplication of the IVC, transposition or left-sided IVC, retroaortic left renal vein, and circumaortic left renal vein. It is suggested that the preoperative diagnosis of the vascular anomalies reduces the complication rate of abdominal vascular procedures. Our vast experience with approximately 400 kidney donors who were evaluated preoperatively with spiral CT scan with three-dimensional reconstruction (3D) reconfirmed this view. Thereafter, it became easier to choose the side and decide between laparoscopic vs. open approach. This prompted us to write the present article focusing on those developmental anomalies of the IVC that may be encountered by the urologist and their implication on the clinical practice.

Serum ferritin in renal cell carcinoma: effect of tumor size, volume grade, and stage.

AIM: To study the levels of serum ferritin in patients of renal cell carcinoma (RCC). PATIENTS AND METHODS: Serum ferritin levels were measured preoperatively in 32 patients with radiological evidence of RCC using an enzyme immunoassay. The largest diameter of the primary tumor was measured in the pathological specimens in patients undergoing radical nephrectomy while in patients with non-operable tumor maximum tumor dimension was taken from CT scan. Pathological staging was done according TNM-1997. RESULTS: Mean serum ferritin value in patients of RCC was 283.23+/-77.38 ng/ml while in controls the mean value was 79.98+/-32.96 ng/ml (P CONCLUSIONS: Serum ferritin levels are elevated in patients with RCC although its actual source is unclear. Further studies are needed to establish the role of ferritin in RCC.

Retroperitoneal ganglioneuroma presenting as right renal mass.

A primary retroperitoneal ganglioneuroma was found in a 37-year-old woman on computed tomography, which revealed a homogeneous mass just above the right kidney. The tumor was resected through a transabdominal approach. The resected specimen measured 11 x 9 x 4.5 cm and weighed 270 g. The histologic examination showed that the lesion was a ganglioneuroma composed of both mature ganglion cells and nerve fibers.

Sigmoid vaginoplasty: long-term results.

OBJECTIVES: To evaluate the long-term results of sigmoid vaginoplasty for Mayer-Rokitansky-Kuster-Hauser syndrome. The social and psychological acceptance of the procedure is also discussed in terms of a developing country scenario. METHODS: A total of 14 patients with Mayer-Rokitansky-Kuster-Hauser syndrome were treated at our institute from January 1995 to December 2004. Sigmoid vaginoplasty was performed in all patients. The procedure was performed using a combined abdominoperineal approach. Dissection was done between the urethra and rectum to create a bed for the neovaginal colon conduit. A 10-cm segment of sigmoid colon was raised on its vascular pedicle, delivered through the abdominoperineal tunnel, and fixed to the vaginal pit incision. The patient records were reviewed for surgical technique and postoperative complications. Patients underwent a personal interview to assess the postoperative results, social acceptance of the procedure, and sexual satisfaction. RESULTS: The mean patient age at surgery was 16.8 years. The patients who underwent sigmoid vaginoplasty had good cosmetic results without the need for routine dilation or the problem of excessive mucus production. The postoperative morbidity was minimal. During a mean follow-up of 4.1 years, no stenosis or colitis was encountered. The subjective satisfaction rate with the surgical outcomes in all the patients was 8.01 on a scale of 0 to 10 (0, very disappointed to 10, satisfied). CONCLUSIONS: Sigmoid vaginoplasty is an effective treatment for patients with vaginal atresia. Timed vaginal reconstruction in these patients allows for a better quality of life and social acceptance. It also enables the patient to lead a near-normal sexual life, with high satisfaction rates.

Endoscopic incision for functional bladder neck obstruction in men: long-term outcome.

OBJECTIVES: To evaluate the long-term outcomes of endoscopic bladder neck incision (BNI) for functional bladder neck obstruction. Functional and/or mechanical obstruction of the bladder neck in men causes lower urinary tract symptoms. Although alpha-blockers are the initial treatment, they often fail to alleviate the symptoms. METHODS: The records of 45 men with obstructive voiding symptoms treated between 1988 and 1996 were reviewed. The symptom score, renal parameters, urine routine microscopy, urine culture and sensitivity, uroflowmetry, voiding cystourethrography, and videourodynamic results were reviewed. Patients with a peak flow rate of less than 10 mL/s, inadequate funneling of the bladder neck, more than 40 cm H2O opening pressure with a relaxed external sphincter, a postvoid residual urine volume greater than 100 mL, no neurologic defect, and a normal urethral caliber were included. They were treated with clean intermittent catheterization and alpha-blockers. Clean intermittent catheterization was stopped when the postvoid residual urine volume was less than 50 mL. BNI was performed in patients with a poor response, noncompliance, or side effects from the alpha-blockers. Postoperatively, patients were assessed by symptom score, uroflowmetry, and postvoid residual urine volume. RESULTS: Of the 45 men, 22 responded to alpha-blockers, 5 chose clean intermittent catheterization, and 18 underwent BNI. The mean patient age was 33.42 +/- 6.56 years. The mean follow-up was 96 months (range 46 to 140). After BNI, all patients showed improvement, with the symptom score improving from 26.9 to 3.6 (P < 0.001). The peak flow rate improved from 8.5 to 19.6 mL/s (P < 0.001). This improvement persisted in more than 80% of the 18 patients. Two required a second BNI and were also doing well at the last follow-up visit. CONCLUSIONS: BNI is an effective treatment for functional bladder neck obstruction refractory to alpha-blockers and provides durable results.

Vascular complications after percutaneous nephrolithotomy: are there any predictive factors?

OBJECTIVES: To evaluate the severe hemorrhagic complications of percutaneous nephrolithotomy (PNL) and their management and to analyze the predictive factors. METHODS: We retrospectively analyzed the data of 1854 patients who had undergone PNL for removal of renal calculi at our institute between 1993 and 2003. All patients were resuscitated with intravenous fluids and blood transfusions. Patients in whom bleeding did not respond to conservative means underwent angiography and subsequent embolization. Multivariate analyses were done to determine the various factors responsible for the occurrence of these lesions. RESULTS: Of the 1854 patients, 27 (1.4%), with a mean age of 38.6 years (range 19 to 63) required angiography and/or embolization for bleeding control. The mean time to the onset of hemorrhage was 8 days (range 2 to 18). Renal arteriography revealed pseudoaneurysm in 13, arteriovenous fistula in 6, a combination of both in 4, lumbar artery injury in 1, and no lesion in 3 patients. In 22 patients, successful embolization of the offending vessel was achieved and in 2 the hematuria recurred. These 2 patients underwent repeat angiography and embolization of the lesion. Metallic coils were used in 13, Gelfoam in 5, and coils and Gelfoam in 8 patients. On multivariate analysis, only stone size was the significant factor predicting for the occurrence of these vascular complications. CONCLUSIONS: Severe hematuria is a rare complication of PNL that can be successfully managed with angioembolization. Our results indicated that stone size significantly predicted for the occurrence of lesions in patients undergoing PNL for symptomatic stone disease.