Clinical profile of 1208 newly diagnosed colorectal cancer patients in Tamil Nadu-A multi-centric survey.

BACKGROUND: An increasing incidence of colorectal cancer (CRC) is being reported in developing countries, including India. Most Indian studies on CRC are retrospective and single-centered. The present study is an attempt to understand the current clinical profile and stage of newly diagnosed CRCs across multiple centers in Tamil Nadu, India. METHODS: A multi-centric observational survey was conducted between September 1, 2021, and August 31, 2022, under the aegis of the Indian Society of Gastroenterology - Tamil Nadu chapter. Patients 18 years of age and older with a recent diagnosis of CRC fulfilling the inclusion criteria were prospectively recruited at the participating centers. Their demographic, clinical, biochemical, endoscopic, histopathologic, radiologic and risk factor details were systematically collected and analyzed. RESULTS: Across 23 centers in Tamil Nadu, 1208 patients were recruited. The male:female ratio was 1.49:1, while mean (SD) age was 57.7 (13.5) years. A majority (81.9%) were Tamils and 78.5% belonged to lower socioeconomic classes. The predominant symptoms were hematochezia (30.2%) and a change in bowel habits (27.5%). The most common locations were the rectum (34.3%) and rectosigmoid (15.1%). Synchronous CRCs were seen in 3.3% and synchronous colorectal polyps in 12.8%. Predisposing factors for CRC were seen in 2%. A past history of any cancer among CRC patients was obtained in 3.1% and a family history of any cancer was found in 7.6%. Patients who were either overweight or obese constituted 46.4% of the study population. At presentation, the predominant stages were stage III (44.7%) and stage IV (20.8%). CONCLUSIONS: A majority of patients with newly diagnosed CRC in Tamil Nadu belonged to the lower socioeconomic classes. About 60% had CRCs located within the reach of the flexible sigmoidoscope. Two-thirds of the patients exceeded stage II disease at presentation. TRIAL REGISTRATION: Not applicable.

A spiraling journey into the small bowel: a case series of novel motorized power spiral enteroscopies.

BACKGROUND AND AIMS: The small bowel has, to date, remained a difficult area to access via endoscopy. The novel motorized power spiral enteroscopy, recently introduced, has more depth of insertion and is of shorter duration. Presented here is a case series of motorized spiral enteroscopies. METHODS: Motorized spiral enteroscopy is indicated for patients requiring deep enteroscopy (eg, for a diagnosis of obscure GI bleeding, suspected inflammatory bowel disorder) and for therapeutic interventions, such as polypectomy, hemostasis, or stricture dilatation. It is contraindicated in patients who are not eligible for general anesthesia, with perforation, or with coagulopathy and in the pediatric population. The contraindications for the anterograde route are gastroesophageal varices, foregut stenosis, eosinophilic esophagitis, and so on. The retrograde approach is contraindicated in active colitis, anal stenosis, or colonic stricture. Informed consent was sought from all the patients. RESULTS: The procedure was successful in 13 of 14 (92.8%) in that the target site was reached or panenteroscopy was confirmed. The diagnoses were stricture and ulcers of the jejunum or ileum. The procedures performed were argon plasma coagulation and stricture dilation. The average duration of anterograde enteroscopy was 61.1 minutes and retrograde enteroscopy was 90 minutes. The major adverse events were hypothermia (3 of 14) and pancreatitis (1 of 14), from which the patients recovered fully. CONCLUSIONS: Novel motorized power spiral enteroscopy is a great tool in small-bowel diagnostics and therapeutics. Speed and ease add to the attractiveness of the procedure.

Sofosbuvir-velpatasvir single-tablet regimen administered for 12 weeks in a phase 3 study with minimal monitoring in India.

BACKGROUND AND AIMS: In clinical studies, sofosbuvir-velpatasvir has demonstrated high cure rates and favorable tolerability in patients chronically infected with chronic hepatitis C virus (HCV) of any genotype. We evaluated the effectiveness and safety of sofosbuvir-velpatasvir administered with minimal medical monitoring to patients in India. METHODS: At 16 sites in India, 129 adult patients with chronic HCV infection of any genotype initiated 12 weeks of once-daily sofosbuvir-velpatasvir (400-100 mg). Patients with compensated cirrhosis or prior treatment experience could be included in the study. Study drug was dispensed monthly, but there were no on-treatment study assessments. The primary efficacy endpoint was rate of sustained virologic response (HCV RNA < 15 IU/mL) 12 weeks after treatment (SVR12), which was compared to a pre-specified performance goal of 85%. RESULTS: The majority of patients had HCV genotype 3 infection (70%), followed by HCV genotype 1 (22%). The SVR12 rate was 93% (120/129; 95% CI, 87% to 97%) (p = 0.009 compared with the 85% performance goal). Of the nine patients who did not achieve SVR12, 1 experienced virologic failure, 2 relapsed after treatment, 1 withdrew consent after treatment, and 5 were lost to follow-up (1 during and 4 after treatment). Sofosbuvir-velpatasvir was well-tolerated, and no patients discontinued treatment because of an adverse event. The most frequently reported adverse events were headache (3% of patients), upper abdominal pain (2%), and pyrexia (2%). CONCLUSIONS: In this study conducted at multiple sites in India, sofosbuvir-velpatasvir administered without genotype restriction or on-treatment safety assessments was well-tolerated and highly effective.

Clinico-microbiological profile and outcomes of nosocomial sepsis in an Indian tertiary care hospital--a prospective cohort study.

BACKGROUND: Nosocomial infections are linked to rising morbidity and mortality worldwide. We sought to investigate the pattern of nosocomial sepsis, device usage, risk factors for mortality and the antimicrobial resistance pattern of the causative organisms in medical intensive care units (ICUs) in an Indian tertiary care hospital. METHODS: We conducted a single-centre based prospective cohort study in four medical ICUs and patients who developed features of sepsis 48 hours after admission to the ICUs were included. Patients' demographics, indwelling device usage, microbiological culture reports, drug resistance patterns and the outcomes were recorded. The Acute Physiology and Chronic Health Evaluation (APACHE) III score and the relative risk of variables contributing towards non recovery were calculated. RESULTS: Pneumonia (49%) was the commonest nosocomial infection resulting in sepsis, followed by urosepsis (21.8%), bloodstream infection (BSI) (10.3%) and catheter-related bloodstream infection (CRBSI) (5%). Sixty three percent of the Acinetobacter baumannii and 64.4% of the Pseudomonas aeruginosa were multidrug-resistant (MDR). Seventy percent of the Klebsiella pneumoniae were extended spectrum beta-lactamase producers and 7.4% were resistant to carbapenems. Forty three percent of the Staphylococcus aureus were methicillin-resistant S. aureus. Resistance to carbapenems was 35.2% in this study. High APACHE III scores (P = 0.006 by unpaired t-test) and chronic kidney disease (P = 0.023) were significantly associated with non-recovery. CONCLUSIONS: A high degree of multidrug resistance was observed among both Gram-positive and -negative organisms in nosocomial sepsis patients. Carbapenem resistance was a common occurrence. Chronic kidney disease and high APACHE III scores were significantly associated with non-recovery. Male gender and sepsis leading to cardiovascular failure were the independent predictors of mortality.