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Current national guidance supports the use of either ultrasound-guided core biopsy (USCB) or ultrasound-guided fine needle aspiration cytology (USFNAC) to detect preoperatively axillary lymph node involvement in early breast cancer but does not support one over the other. To compare the accuracy of USFNAC to USCB in diagnosing axillary lymph node metastasis in early-stage breast cancer in our symptomatic breast care unit. Historical case series data for patients from November 2007 to May 2012 was analysed. Our study included newly diagnosed, symptomatic, clinically node-negative breast cancers. Women with screen-detected breast cancer, those who had breast staging by magnetic resonance imaging, those unfit for surgery and those with locally advanced cancers were excluded. GE Logic E9 and Philips ultrasound machines were used for the study. A total of 1213 axillary ultrasound scans were performed during the period of the study. Four hundred eighty-eight women were eligible for the study with a mean age of 57.8 years. Eighty-three (17%) had USFNAC, 116 (23.7%) had USCB and 289 (59.2%) had normal/benign US features. The sensitivity and specificity of USFNAC were 58% and 100%, respectively. For USCB, sensitivity and specificity were 82% and 100%, respectively, and for US alone, sensitivity and specificity were 50% and 77%, respectively. We support the routine use of USCB over USFNAC for women who have breast cancer with indeterminate or suspicious axillary involvement on ultrasound, due to its greater accuracy.

ObjectiveLarge 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.DesignSecondary 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.Setting39 public and private hospitals across India during the study period from 22 April to 14 July 2020.ParticipantsOf 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 measureFactors associated with all-cause mortality at 28 days after enrolment.ResultsThe 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 (p2/FiO2 ratio 10 (9.97, 3.65–27.13, p1.0 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.ConclusionIn 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 numberCTRI/2020/04/024775.

ObjectivesConvalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19.DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial.SettingThirty-nine public and private hospitals across India.ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 ≤ 93% on room air).InterventionParticipants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm.Main Outcome MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment.ResultsBetween 22ndApril to 14thJuly 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: −0.61 to 1.83].InterpretationCP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19.Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.

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.Prospective randomized, concealed, unblinded, multicenter, pilot trial.Three university-affiliated medical-surgical ICUs.Sixty-five adults anticipated to require MV48 hrs and receiving sedative/analgesic infusions.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.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).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.

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.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.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.Hem-o-lok clips are a reliable and cost-effective means of achieving vascular control during laparoscopic nephrectomy.

Objectives : Bladder neck suspension using polypropylene is an established technique for treatment of stress urinary incontinence (SUI). We report our retrospective audit of the bladder neck sling in SUI. MaterialS and Methods : Twenty-one patients with SUI operated at our institute were included in the study. The audit was performed using the case records for - patient demographics, detailed history and examination, routine hemogram, renal function tests, urine culture sensitivity, urine microscopic examination and uroflowmetery + cystometrogram(CMG). After complete evaluation, all patients underwent bladder neck suspension using polypropylene mesh. Results : Twenty-one patients with mean age of 55 years underwent bladder neck sling surgery. Mean duration of surgery was 67 minutes (50-100 minutes). Mean operative blood loss of 100ml. Mean duration of hospital stay was 2days (1-5 days). Eighteen patients had complete or significant decrease in the severity of stress urinary incontinence in immediate post-operative period. Mean duration of follow up of patients was 19 months (3-28 months). All patients were dry at the end of the follow up. Conclusions : Broad base polypropylene mesh gives good continence results in patients of SUI.

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.

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.

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.

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 × 9 × 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.

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.

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.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.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 (P0.001). The peak flow rate improved from 8.5 to 19.6 mL/s (P0.001). 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.BNI is an effective treatment for functional bladder neck obstruction refractory to alpha-blockers and provides durable results.

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.

Purpose:0 We analyzed various modes of presentation of chyluria in our patients. Various treatment options available and associated complications were also studied. Materials and methods:0 Retrospective review of records of patients of chyluria treated at our institute between January1987 to June 2005 was done. Chyluria was diagnosed by urine examination. Treatment was tailored according to severity of chyluria, which included dietary modification, antifilarial drugs and sclerotherapy. Those not responding to two sessions of sclerotherapy were taken up for chylolymphatic disconnection. Results:0 A total of 600 patients were treated between January 1987 and June 2005. Before 1999 we routinely used 1% silver nitrate. Between January 1999 and June 2003, povidone iodine (0.2%) and dextrose (50%) were also used besides silver nitrate (1%). Instillation of dextrose was used in 21 patients only and its use was discontinued because of high immediate failure (57%) and recurrence rate (38%). Instillation of povidone iodine was as effective as silver nitrate. 91% of the patients in the silver nitrate and 98% in the povidone group showed immediate clearance. The chyluria recurred in 21 and 22% in two groups, respectively. The cumulative success rate after two courses of sclerotherapy was 82% in the silver nitrate and 83% in the povidone group. Side effects were much less with povidone iodine. Those who did not responded to two courses of sclerotherapy did well after chylolymphatic disconnection. Conclusion:0 Presenting symptoms of chyluria vary according to severity of the disease. Most patients respond to dietary modifications, antifilarial drugs and sclerotherapy. Those not responding to sclerotherapy do well after chylolymphatic disconnection.