Changes in liver function tests in laparoscopic cholecystectomy versus open cholecystectomy in a tertiary care center

Background: Gallstone disease is a major health problem worldwide particularly in the adult population. The traditional open cholecystectomy (OC) has been replaced by laparoscopic cholecystectomy (LC), with LC becoming the gold standard for management of gall stone disease. Elevation in the levels of liver enzymes following LC is a major cause of concern. Hence the present study determines and compares the changes in liver function tests following Laparoscopic cholecystectomy with open cholecystectomy, as well the significance of these changes is studied. Methods: A total of 100 patients with symptomatic cholelithiasis were selected in the study from October 2020 to October 2022. The cases were randomly divided into two groups, Group LC and Group OC. The blood samples were collected for Liver Function Tests (LFT)-Pre-operatively, Post-operative Day (POD)-1, POD-2 and POD-7 and enzyme alterations were studied. Results: The study demonstrated increase in levels of Serum AST, ALT, ALP in LC group on POD-1 and POD-2 with p<0.001, while the levels returned to reference values on POD-7. In OC group the increase in levels of Serum AST, ALT, ALP were observed on POD-1 only with p<0.05 and the levels returned to normal values by POD-2 of majority of patients. The changes in LFT were higher in LC group compared to OC group (where the changes were slight). Conclusions: Cholecystectomy especially laparoscopic, leads to transient significant hepatic enzyme alterations which can be attributed to CO2 pneumoperitoneum, surgical manipulations, diathermy and arterial injury. These derangements at times may be of concern to surgeons for its implication to the integrity of biliary tract

Acute Appendicitis: Correlation Between Ultrasonographic And Surgical Findings

Aim: The main aim of our study is to estimate sensitivity and specificity of Ultrasonography in identifying acute appendicitis in patients with symptoms of right iliac fossa pain and its role in the therapeutic management. Materials and methods: 100 patients who presented to surgical out patient department, with symptoms of right iliac fossa pain. They underwent ultrasonography and appendectomy followed by histopathological examination of the specimen. Obese persons (due to difficulty in imaging) and patients requiring emergent surgery were excluded from our study. Ultrasound was done in supine position and in left lateral oblique position, using graded compression technique. Results: Out of the hundred patients selected in our study, 64 were male patients, of which 49 were diagnosed to have acute appendicitis and 36 were female, of which 25 were diagnosed to have acute appendicitis on USG. 2 males and 2 females were diagnosed to have appendicular mass on USG. Maximum age was 67 years and minimum age was 3 years. Maximum number of patients were in the age range of 11-20 years. Based on the Alvarado value (more than 5 were taken to have appendicitis), 73% were likely to have appendicitis. On USG, 74 patients were diagnosed to have acute appendicitis of which 73 were confirmed on histopathology. On histopathological examination of all the removed appendix specimens, 76 were diagnosed as acute appendicitis. Sensitivity of USG in diagnosing acute appendicitis in our study was 96.05%. Specificity was 95.83%. The positive predictive value of the study is 98.64% and negative predictive value is 88.46%.The most common position of appendix in our study was retro-caecal (78.20%), followed by pelvic(16.66%). Conclusion: Ultrasound has high sensitivity and specificity for diagnosis of appendicitis and should suffice as the modality of choice whenever the appendix is identified. CT should be reserved for complicated cases in which the appendix is not identified or the presence or absence of perforation cannot be determined with ultrasound, and histopathology should remain as gold standard

Comparative Study of Negative Pressure Wound Therapy Versus Conventional Wound Therapy of Lower Limb Ulcers

Background: Wounds and their management are fundamental in the practice of surgery. Negative Pressure Wound Therapy (NPWT) uses negative pressure to assist wound healing. Negative pressure drains fluid from the wound, thus removing the substrate for growth of microorganisms. Aim: To assess the efficacy of negative pressure wound therapy as compared to conventional wound therapy in improving the healing process in chronic wounds and ulcers. Materials and Methods: the study was in the department of general Surgery with 50 patients comprising of  25 cases were randomly chosen for study with negative pressure and 25 cases received normal dressing for the wounds.Result: The age of the patients ranged from 20 years to 80 years with mean age Group A – 54.28±11.55 and Group B – 54.52±11.03. Foot remained the site for highest number of ulcers in both the groups followed by leg, however the least number of ulcres was found on thigh. The wound size in the study group before and after treatment shows statistically significant. Conclusion:Negative Pressure Wound Therapy is safe, has faster response in wound healing and gives better efficacy as compared to the Conventional Wound Therapy

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics

Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial

BackgroundSparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.MethodsPROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850.FindingsBetween Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals.InterpretationOver 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function

Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial

Background Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis. Methods PROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850. Findings Between Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals. Interpretation Over 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function.</p