Occurrence of psychiatric disorders in the patients of multi drug resistant tuberculosis under treatment

Background: Tuberculosis (TB) is considered as one of the leading causes of mortality worldwide. Even though fatality of TB is well known, treatment non-adherence is major barrier related to management of TB. Studies have shown that there is strong association between psychiatric disorders and treatment nonadherence to TB. Psychiatric issues present a challenge in the treatment of patients with multi drug-resistant tuberculosis (MDR-TB). Both baseline psychiatric disorders and development of psychiatric complications related to anti-tuberculosis drugs require aggressive management for better management of TB. The objective of the present endeavour was to study the occurrence of psychiatric complications in patients of MDR-TB during treatmentMethods: Patients of MDR-TB registered at PMDT centre situated at a tertiary level hospital were screened for psychiatric disorder by using GHQ-12 and assessment was done using structured clinical interview for DSM-IV-TR (SCID-1) research version. Diagnosis of psychiatric disorder was made on the basis of DSM-IV-TR.Results: Psychiatric disorders were already present in 8 (6.15%) patients before the start of MDR-TB treatment and development of psychiatric disorder in 12 (9.23%) patients after initiation of the treatment. Depressive disorder (n=9; 6.9%), anxiety disorder (n=5; 3.8%) and psychosis (n=4; 3.1%) were most frequent psychiatric disorders.Conclusions: GHQ-12 was found to be very useful screening instrument for detection of psychiatric disorders. The regimen IV anti tubercular drugs used for the treatment of MDR-TB drug resistant tuberculosis, significantly increases the risk of development of psychiatric disorders.

A study to know the prevalence of genital tuberculosis in female’s pulmonary tuberculosis patients and role of cartridge based nucleic acid amplification test in genital tuberculosis from North India

Background: Mycobacterium tuberculosis, most commonly, infects the lungs (pulmonary TB). Most cases of female genital TB (FGTB) are found in premenopausal women, theoretically because an atrophic endometrium provides a poor milieu for mycobacterial growth. Female genital TB generally occurs secondary to pulmonary (commonest) and more common in women with reproductive age group. The present study was designed to know the prevalence of genital tuberculosis in female’s pulmonary tuberculosis patients and role of cartridge based nucleic acid amplification test (CBNAAT) in genital tuberculosis.Methods: The patients of female’s pulmonary tuberculosis were picked up from out-patient and in patients’ section of the hospital at random. After ruling out pregnancy, the endometrial samples were collected from premenstrual endometrium (approximately 2-3 days before menstruation) and were subjected to histopathological examination and CBNAAT. Day 1 or 2 menstrual blood of unmarried females and patients not giving consent for biopsy were taken.Results: Seventy married and 20 unmarried patients of female pulmonary tuberculosis patients were evaluated for genital tuberculosis. The mean age of married population was 29±7.68 years. Cough with expectoration was most common respiratory symptoms and seen in 94% cases. In present study 89% cases were sputum positive and 11% were sputum negative. The percentage of non MDR and MDR TB cases were respectively 95.7 and 4.2% respectively. Among the gynecological symptom’s irregular menstruation, vaginal discharge and pelvic pain were present in 68, 60 and 52% of the study patients respectively. The diagnosis of FGTB by histopathology examination and CBNAAT were 28.6 and 17.1% respectively.Conclusions: In present study FGTB diagnosed by histopathology examination and CBNAAT were 28.6 and 17.1% respectively and which was statistically significant (c2=28.25 and p value=0.00001)

A study to investigate the prevalence of metabolic syndrome in Chronic Obstructive Pulmonary Disease patients from North India

Background: Worldwide, Chronic obstructive pulmonary disease (COPD) is the one of the leading cause of chronic morbidity and mortality. COPD is one of the diseases in which smoking is the common and important risk factor when it is associated with Metabolic syndrome (MetS). The individual components of MetS, i.e., obesity, dyslipidemia, fasting hyperglycaemia, and hypertension were independently associated with impairment of lung function too. The objective of this study is to find out the prevalence of metabolic syndrome among COPD patients.Methods: This was a cross-sectional study conducted in department of Respiratory Diseases and a total of 70 COPD patients were included in the study, which were enrolled for treatment from July 2016 to July 2017. The severity level in patients with COPD were determined according to GOLD (Global Initiative for Chronic Obstructive Lung Disease), 2015 guideline. International Diabetes Federation (IDF) guideline; (2005) was used in diagnosis of metabolic syndrome.Results: Seventy patients with COPD were enrolled during the study period. There were 45 males (64.2%) and 25(35.7%) females. Mean age of male patients was 58.67±9.87 years, while mean age of female patients was 57.23±10.4 years (35-87 years). Mean BMI of male was 24.33±6.64 kg/m2, while in case of female it was 30.07±6.95 kg/m2 and overall mean BMI of study population was 26.22±7.22 kg/m2. The mean   waist circumference of male was 86.91±13.31 cm while in female it was 87.18±14.51 cm. The Overall prevalence of metabolic syndrome was 31.34% and most common in GOLD stage-3 (47.06%), followed by stage-2 (40%), followed by stage-4 (25.71%) and 7.4 % in GOLD stage -1.Conclusions: The presence of metabolic syndrome is common in patients with COPD and, all COPD patients should be considered for screening for it

Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

Background: Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods: We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. Findings: Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). Interpretation: We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study)

BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019

Minimally invasive right colectomy anastomosis study (MIRCAST):protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor

Abstract Background: Right colectomy is the standard surgical treatment for tumors in the right colon and surgical complications are reduced with minimally-invasive laparoscopy compared with open surgery, with potential further benefits achieved with robotic assistance. The anastomotic technique used can also have an impact on patient outcomes. However, there are no large, prospective studies that have compared all techniques. Methods/design: MIRCAST is the Minimally-Invasive Right Colectomy Anastomosis Study that will compare laparoscopy with robot-assisted surgery, using either intracorporeal or extracorporeal anastomosis, in a large prospective, observational, multicenter, parallel, four-cohort study in patients with a benign or malignant, non-metastatic tumor of the right colon. Over 2 years of follow-up, the study will prospectively evaluate peri- and postoperative complications, postoperative recovery, hospital stay, and mid-term results including survival, local recurrence, metastases rate, and conversion rate. The primary composite endpoint will be the efficacy of the surgical method regarding surgical wound infections and postoperative complications (Clavien-Dindo grade III-IV complications at 30 days post-surgery). Secondary endpoints include long-term oncologic results, conversion rate, operative time, length of stay, and quality of life. Discussion: This will be the first large, international study to prospectively evaluate the use of minimally-invasive laparoscopy or robot-assisted surgery during right hemicolectomy and to control for the impact of the anastomotic technique. The research will contribute to current knowledge regarding the medical care of patients with malignant or benign tumors of the right colon, and enable physicians to determine which technique may be the most appropriate for their patients. Trial registration: This study was registered on Clinicaltrials.gov (clinicaltrials.gov identifier: NCT03650517) on August 28th 2018 (study protocol version CI18/02 revision A, 21 February 2018)

Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh with Primary Perineal Wound Closure after Extralevator Abdominoperineal Resection (BIOPEX-study)

Objective: To determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia. Summary Background Data: BIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing). Methods: This was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic. Results: Actuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome. Conclusions: Symptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes