Care Referral Center In India Research Articles

De Novo Seizures, Obsessive Compulsive Symptoms and Neutropenias in Patients on Clozapine: A Retrospective Cohort Study.

Clozapine has well-documented inter-ethnic variations in pharmacokinetics. There is a paucity of data about clozapine use and associated adverse events such as seizures, obsessive compulsive symptoms, neutropenia, and agranulocytosis, from India. This retrospective cohort study followed up 228 patients initiated on clozapine in a tertiary care referral center in India for an average of 10 years. We calculated incidence rates of new-onset seizures, new-onset obsessive compulsive symptoms, agranulocytosis, and neutropenia. We collected data on doses of clozapine used and serum assays and calculated concentration-to-dose (C/D) ratios. We also collected relevant clinical details about clozapine-induced seizures. In the sample, 16.8% had new-onset seizures, 12.3% had new-onset OC symptoms, 2.7% had neutropenia, and 0.9% had agranulocytosis. The mean C/D ratio was 2.09 (SD = 1.8). Almost half (46.3%) of available serum assays were in the supra-therapeutic range. Seizures were associated with a higher clozapine dose at one year (OR = 1.003; 95%CI = 1.000-1.006; P value = 0.045) and the presence of positive psychotic symptoms at one year (OR = 4.214; 95%CI = 1.894-9.373; P < 0.001). Compared to existing literature, Indians have a higher rate of clozapine- related seizures and need lower doses to reach therapeutic serum levels.

Clinical Presentation, Treatment, and Challenges in the Management of Child Sexual Assault at a Tertiary Care Referral Center in India.

Child Sexual Assault (CSA) is not an uncommon but an under-reported crime. Along with social and psychological critical issues, there are multiple challenges faced by the surgical team for the treatment of complex perineal injuries associated with CSA. This study was conducted to find clinical presentation and management of CSA along with its problems and challenges encountered by the pediatric surgical team. This was a retrospective study from 2010 to 2019, conducted in the department of pediatric surgery at a tertiary referral center. All-female patients with a definitive history of sexual assault were included in the study. Seven patients fulfilled the inclusion criteria and the mean age was 5.3years. After a primary survey, all patients were taken up for examination under anesthesia (EUA). Three patients were managed by the primary repair of the wound and did well during follow-up. Four patients had grade 4 perineal injury and required stage reconstruction. As a first stage, repair of rectal tear, vaginal tear, and the perineal body reconstruction was done along with diversion colostomy. One patient required redo repair of the perineal body and one had developed a rectovaginal fistula. Three patients completed all stages and they are fully continent. The spectrum of injuries varies widely in CSA and more chances of high-grade perineal injuries in children due to distinctive local anatomy. EUA is crucial to assess the extent of the injury and to decide the course of management. Meticulous anatomical repair and diversion stoma is the key for successful complex repair and excellent long-term outcomes in terms of continence for the severe grade of perineal injuries.

Outcomes of Advanced Epithelial Ovarian Cancers Treated with Neoadjuvant Chemotherapy and Interval Debulking Surgery: An Audit from a Tertiary Care Referral Center in India

This institutional audit was conducted to analyze the surgical and survival outcomes in advanced epithelial ovarian cancers treated with neoadjuvant chemotherapy and interval debulking surgery. Clinical records of patients of advanced epithelial ovarian cancers treated between January, 2011, and December, 2014, were retrospectively reviewed. Standard demographics, disease-related factors and treatment-related outcomes were analyzed. A total of 100 patients were included for analysis. A majority (97%) received paclitaxel and carboplatin in the neoadjuvant setting. The number of cycles of NACT did not affect the status of residual disease after IDS (P = 0.307). At a median follow-up of 69 months, the median PFS was 17.5 months (0–89) and median OS was 32 months (5–89). A chemotherapy response score of 3 was significantly associated with an improved PFS (P = 0.032*). No significant difference in PFS was noted with respect to the number of cycles of NACT; however, a trend was observed in favor of ≤ 3 cycles (P = 0.218). On subset analysis, patients with stage IIIC disease showed a trend towards better PFS with ≤ 3 cycles of NACT, though not statistically significant (P = 0.075). Also, no difference in PFS was noted if the total number of chemotherapy cycles was increased beyond 6 (P = 0.309). The survival outcomes reported here are consistent with most results published in the literature. CRS is an important prognostic biomarker. Increasing the number of chemotherapy cycles beyond 6 does not affect survival. No definite conclusion could, however, be drawn with respect to the ideal number of NACT cycles and needs further evaluation.

Relative importance of inflammatory markers in deciding infection versus inflammation

Background: Fever is the commonest presentation of pediatric patients attending emergency departments of all children’s hospital. The cause of fever may be acute bacterial infections or primary vasculitic disorders like Kawasaki disease or inflammation due to non-bacterial infections. The objective was to compare the performance of the four biomarkers ESR, CRP, Procalcitonin and IL-6 in predicting a diagnosis of sepsis/infection and find out a definite cut off value for the statistically most significant one.Methods: The authors conducted this prospective observational study at the indoors of a pediatric tertiary care referral center in India to find out a biomarker which can differentiate between infection and inflammation (vasculitis) in children admitted with fever and finally diagnosed as infection or inflammation (vasculitis).Results: Among ESR, CRP, Procalcitonin and Interleukin-6, only IL-6 showed statistical significance in differentiating infection from inflammation (vasculitis) analysed using the Receiver Operating Characteristic (ROC) curve and Mann-Whitney U test, sensitivity and specificity.Conclusions: IL-6 level 27 pg/mL or less at the time of admission indicates an infectious etiology while level more than this indicates towards a vasculitic cause.

Cost analysis of oral cancer treatment in a tertiary care referral center in India.

Cost analysis of oral cancer treatment in a tertiary care referral center in India.

Locally advanced colorectal cancer: Is a second look surgery and prophylactic HIPEC warranted?

e15056 Background: Peritoneal recurrence/carcinomatosis (PC) after curative surgery for colorectal cancer is the second most common site of recurrence and carries a poor prognosis. PC present relatively in the later stage, are difficult to detect by conventional imaging on follow up, and have limited options to treat after diagnosis. Second look surgery is the only definite option to diagnose early PC and presents an opportunity for disease control by cytoreductive surgery (CRS) and HIPEC. Multiple studies have attempted to identify clinico-pathological risk factors that predict high chances of PC. Our aim is to analyze the recurrence patterns and survival in locally advanced colorectal cancer, in an attempt to identify high risk factors for PC, which can be used as an indication for second look surgery and prophylactic HIPEC in such cases. Methods: Retrospective analysis of a prospectively maintained data of all colorectal cancer patients presenting to a tertiary cancer care referral center in India, from May 2010 to October 2015 was done. All patients who underwent surgery with curative intent and were clinico-pathological stage T4 and/or N2 M0 were included in the analysis. Results: 182 patients underwent curative resection with a clinico-pathological staging of T4 and/or N2 M0. There were 71 recurrences, out of which 30 (42.2%) were peritoneal, 7 (9.9%) were hepatic only while 34 (47.9 %) were non-hepatic systemic or multiple site. For a median follow up of 26 months, the estimated 3 year OS was 78 % while the 3 year DFS was 50.4 %. The median time to diagnosis of peritoneal recurrence was 13 months (4.7 – 55.7). The 3-year OS for patients with peritoneal recurrence was 48.6 % as against 57 % for liver only recurrence and 59.9 % for non liver systemic and multiple site recurrence, with a trend towards poorer survival for peritoneal recurrences, although non-significant (p – 0.377). Conclusions: Locally advanced colorectal cancer has a high risk of peritoneal recurrence which negatively impacts the survival. Well-designed RCTs need to be conducted to identify the high risk factors for PC and whether second look surgery and prophylactic HIPEC in such patients will improve survival with acceptable morbidity and mortality.

Cost Analysis of Oral Cancer Treatment in a Tertiary Care Referral Center in India

Introduction: As much as the number of oral cancer patients is a heavy burden to the health care system in India, so much is the economic burden to the patient and the relatives, especially in India where most do not have any financial cover for their medical expenditure. Objectives: To find out the approximate cost of treatment of oral cancer through various modalities, and calculate the proportion of direct and indirect expenses, and then identify the factors which would increase the indirect expenses so as to come up with recommendations which will reduce the indirect cost thereby reducing the financial burden to the patient.Methods: A retrospective observational study was done in a tertiary care center for cancer treatment and the direct cost (medical expense), indirect cost (non-medical expense) incurred by the patients, their economic status and source of fund for payment of the expenses were obtained. Results: The proportion of indirect cost was about 38.72% of the total cost for patients who underwent a single modality treatment with surgery, around 34.73% for a combination treatment with surgery and RT (Radiotherapy), about 79.63% for treatment with conventional Radiotherapy without surgery and about 49.61% for treatment with IMRT (Intensity Modulated Radio Therapy) without surgery. Availability of financial aid or cover is abysmally poor. The rate of discontinuance of treatment is also very high according to this study.Conclusion: The proportion of the indirect cost is very high and the total expenditure can be reduced by approximately 30% by following measures discussed in this article.

Infections Are a Major Cause of Prolongation of Hospital Stay in Hematopoietic Stem Cell Transplants in Tropical, Developing Countries: Profile of a Transplant Center in North India

▪Introduction: There are evidence based guidelines for the prophylaxis and management of infections in hematopoietic stem cell transplant recipients. However, the infection profile of transplant centers differs from center to center even in different regions of the same country. The reported incidence of bacterial, fungal and viral infections ranges widely from 13-60%, 4-30% and 2-16% respectively across the world. Here we report the infection profile in our transplant center.Methods: This was a retrospective study done at a tertiary care referral center in India. Data of hematopoietic stem cell transplants from 2004 –2014 was analyzed. All recipients received trimethoprim-sulphamethoxazole, levofloxacin, fluconazole and acyclovir prophylaxis. Voriconazole was used in allogeneic transplants after 2011. Definite bacterial infections were defined as any positive cultures from blood, urine, sputum, pus. Definite infective diarrhea was defined as stool culture or Clostridium difficile toxin positivity. Definite fungal infection required confirmation by culture or histopathology. Probable fungal infection required one each of host factors, clinical features and mycological evidence. Possible fungal infection required any one of the above three factors. Antifungals were started on day 3-5 as per the febrile neutropenia guidelines. CMV was monitored by RQ-PCR weekly till 100 days post transplant. All recipients were nursed in HEPA (high efficiency particulate air) filtered rooms till the resolution of infection or engraftment whichever was later.Results: Data of first 100 (36 allogeneic and 64 autologous) transplants was analyzed. All patients except 3 developed fever requiring antibiotics. There were 68 documented bacterial infections in 47 transplant recipients (47%). Gram negative were the most frequent isolates 49/68 (72.1%) followed by Gram positive organisms 19/68 (27.9%). Polymicrobial infections were seen in 11 patients (16.1%). Infections were significantly more common in allogeneic (26/36) than autologous transplant recipients (34/64) (p=0.005). Diarrhea was seen in 59 patients. Clostridium difficile toxin positivity was seen in 7 cases (11.8%).CMV infection was seen in 9 allogeneic HSCT recipients (25%). All patients had ongoing GVHD at the time of CMV reactivation and were on additional immunosuppression with corticosteroids. The diagnosis of fungal infection was made in 54 patients (54%). It was categorized as probable in 10 and possible in 44. Definite fungal infections could not be documented in any case. Antifungals were used for a median duration of 4.5 days (SD ±6.9).Infection attributed mortality was 9%. The median duration of antimicrobial usage was 13 days (SD±9.2). The median duration of total hospital stay was 38 days (SD±31.7). The median day of neutrophil engraftment was 12 days (SD±3.5). Multiple regression analysis revealed duration of antimicrobial use to be associated with hospital stay (p<0.0001).Conclusions: Antimicrobials were used for up to one third of the total hospital stay of HSCT. Bacterial and fungal infections were the major cause for prolongation of the hospital stay in our center. The incidence of possible fungal infections is higher than centers in other parts of the world and signifies the need for alternative detection methods to confirm the diagnosis. Whether the agent, host or environment factor in tropical and developing countries, contributes to this increased risk of infections needs to be evaluated in a prospective study. DisclosuresNo relevant conflicts of interest to declare.

Clinical profile of insulinoma: analysis from a tertiary care referral center in India

To describe the clinical presentation, localization techniques, surgical procedures and outcome in patients with insulinoma. Retrospective analysis of case records of patients diagnosed with insulinoma between January 1993 and June 2009 at a tertiary-care hospital was done. Seventeen patients underwent diagnostic 72-h fast. The sensitivity of computed tomography (CT) of pancreas was judged using intraoperative findings as the gold standard. Twenty-six patients (19 women) with mean age 42.2 years (median age 39.5 years) with biochemical/imaging evidence of insulinoma were included. All patients who underwent 72-h fast developed symptomatic hypoglycemia within 48 h. The sensitivity and positive predictive value (PPV) of CT of pancreas was 68.4% and 92.8%, respectively. Twenty patients underwent surgery, of whom four were operated on without preoperative localization. Four patients had recurrence of symptoms. Of the six patients who were not operated upon, the lesion was localized in four. This audit shows that all patients with insulinoma develop hypoglycemia within 48 h of fasting. CT of pancreas localizes the lesion in two thirds of cases and would be a useful initial investigation in patients with suspected insulinoma.

Efficacy and tolerability of imatinib mesylate in pediatric chronic myeloid leukemia in a large cohort: Results from a tertiary care referral center in India

10047 Background: Chronic myeloid leukemia (CML) is a rare disease in children and there is limited data of safety and efficacy of imatinib mesylate (IM) in this age group. Methods: We analyzed the outcomes of 48 consecutive children (September 1998 to December 2008) in chronic phase (CP) or accelerated phase (AP) CML not eligible for Allo-SCT and were treated with IM [Glivec (Novartis), through patient assistance programme GIPAP or Veenat (NATCO), generic brand for GIPAP ineligible patients] within 12 months of diagnosis. The dose of IM was 260 mg/m2(maximum 400 mg) per day. Results: The median age at the time of diagnosis was 12 years (range 3–18 years). Of 48 patients, (34 males and 14 females) 46 were in CP and 2 in AP. Forty-three patients (89.5 %) achieved complete cytogenetic response (CCR) at median time of 10 months (range 3–31 months). Five patients (10 %) had hematological response but did not have CCR, of which 2 progressed to AP and 1 had hematological relapse. One patient had secondary IM resistance and had progressive disease even on dose escalation. Two patients in AP at diagnosis achieved CCR at 5 and 7 months and continue to be in CCR. Thirty-one out of 35 patients on Glivec and 12 out of 13 patients on Veenat achieved CCR. At a median follow up 29 months, the event free survival and overall survival was 74.1% and 100 % respectively. IM was well tolerated with grade III and IV neutropenia and thrombocytopenia seen in 2 and 7 patients respectively. Significant non hematological toxicities were uncommon except for hypopigmentation which was seen in more than half the cohort. Conclusions: Results from this largest single center study indicate that outcome of children with CML receiving IM is similar to adults. This data will be especially useful for financially challenged patients in developing countries where Allo-SCT is still not an affordable option while generic brand of IM seems to be feasible alternative. No significant financial relationships to disclose.

The Spectrum of Skin Disease Among Indian Children

Skin diseases in children are encountered frequently and their characterization is essential for the preparation of academic, research and health plans. A retrospective study was designed to evaluate the epidemiologic features of pediatric dermatoses in India. The setting was a tertiary care referral center in India (Kalawati Saran Children's Hospital, New Delhi) during January 1997 to December 2003. A total of 30,078 children less than 12 years of age with 32,341 new dermatoses were recorded, with a male to female ratio of 1.07:1. Most of the disease was seen in the 1- to 5-year age group (44.94%). The most common skin diseases were infections and infestations (47.15%) consisting of bacterial infections (58.09%) and scabies (21.54%), followed by eczemas (26.95%), infantile seborrheic dermatitis, scabies, and pityriasis alba. Other unique dermatoses in our settings were papular uticaria (3.59%), miliaria (5.46%), postinflammatory pigmentary abnormalities (1.68%), and nutritional deficiency dermatoses (0.45%). A majority of patients were diagnosed clinically and special diagnostic tests were conducted in 2.6% of patients. The most common diagnostic test used was KOH mount (59.2%), followed by skin biopsy (39%). Nearly 90% of patients were seen without any referral and in the remaining, a majority were referred by pediatricians (75%). A majority of patients were diagnosed to have infection followed by dermatitis in our setting.

Management of Insulinomas: Analysis from a Tertiary Care Referral Center in India

The aim of this study was to describe the localization and management of patients with pancreatic insulinomas and determine the most effective localization and surgical techniques in the presence of significant financial constraints in the patient population. We retrospectively reviewed the case records of 18 patients with insulinomas treated at our institution over a period of 10 years. The medical records were reviewed for demographic data, clinical presentation, biochemistry, details of localization studies, intraoperative findings, postoperative outcome, and long-term follow-up. The sensitivities of the various localization procedures were calculated using the intraoperative findings as the gold standard. There were 10 men and 8 women in the study, with a median age of 43 years. All patients underwent a supervised 72-hour fast and developed symptomatic hypoglycemia within 48 hours. An average of 1.9 localization procedures was performed per patient. Computed tomography (CT) had a sensitivity of 62% and specificity of 100%. Magnetic resonance imaging and digital subtraction angiography had specificities of 85% and 100%, respectively, with a specificity of 66% and 50%, respectively. Fourteen patients underwent surgery. Intraoperatively the excised tumor was palpable in nine patients, and all patients had postoperative euglycemia. In five patients the tumor was not palpable during the time of surgery; three of these patients underwent blind distal pancreactomy, with two patients having persistent hypoglycemia during the postoperative period. Two patients had a negative exploratory laparotomy. Patients with a surgical cure were followed up for a mean period of 24 months. On the background of financial constraints in connection with patient care, CT scanning is a cost-effective option with good specificity. Intraoperative palpation of the tumor and enucleation is the most effective technique for surgical cure. Blind distal pancreactomy is not advocated for tumors that are not localized intraoperatively.

Clinical Profile, Treatment, and Visual Outcome of Serpiginous Choroiditis

The purpose of this study was to report the clinical profile and management of patients with serpiginous choroiditis in a tertiary care referral center in India. In a retrospective cohort study, 107 eyes of 70 patients with serpiginous choroiditis seen between January 1995 and December 2002 were analyzed. Systemic steroids and immunosuppressives were the mainstay of therapy. Antituberculous and antiviral drugs were used in selected cases. There was male preponderance (7:3). Age at presentation ranged from 11 years to 52 years (mean 30.3 ± 9 years); 52.9% had bilateral involvement. Vision improved or maintained in 86% eyes and deteriorated in 15 eyes (14%). The main cause of decrease of vision was macular involvement. Improvement in vision and resolution of lesions in patients with serpiginous choroiditis can occur with combination therapy of systemic steroids and immunosuppressive agents. Serial examination at regular intervals is needed to monitor the disease progression, recurrences, and involvement of the other eye.