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1.
Ann R Coll Surg Engl ; 106(3): 213-218, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37218655

ABSTRACT

INTRODUCTION: Colorectal liver metastases (CRLM) are associated with a high recurrence rate after surgery. There is paucity of high-quality evidence regarding the nature and overall benefit of surveillance after hepatectomy for CRLM. As part of a broader programme of research, this study aimed to assess current strategies for surveillance after liver resection for CRLM and outline surgeons' opinions regarding the benefit of postoperative surveillance. METHODS: An online survey was sent to clinicians performing surgery for CRLM at tertiary hepatobiliary centres in the UK. RESULTS: There were responses from a total of 23 centres (88% response rate); 15/23 centres used standardised surveillance protocols for all patients. Most centres followed patients up at six months, but there is variation in postoperative surveillance at 3, 9, 18 and beyond 60 months. Patient comorbidities, indeterminate findings on imaging, margin status and assessment of recurrence risk were identified as the major factors influencing personalised surveillance strategies. There was clear clinician equipoise regarding the costs and benefits of surveillance. CONCLUSION: There is heterogeneity in postoperative follow-up for CRLM in the UK. High-quality prospective studies and randomised trials are necessary to elucidate the value of postoperative surveillance and identify optimal follow-up strategies.


Subject(s)
Colorectal Neoplasms , Liver Neoplasms , Humans , Cross-Sectional Studies , Prospective Studies , Hepatectomy , Liver Neoplasms/surgery , Colorectal Neoplasms/surgery
3.
Sci Rep ; 13(1): 16087, 2023 Sep 26.
Article in English | MEDLINE | ID: mdl-37752170

ABSTRACT

We present experimental results of the trace argon impurity puffing in the ohmic plasmas of Aditya-U tokamak performed to study the argon transport behaviour. Argon line emissions in visible and Vacuum Ultra Violet (VUV) spectral ranges arising from the plasma edge and core respectively are measured simultaneously. During the experiments, space resolved brightness profile of Ar1+ line emissions at 472.69 nm (3p44s 2P3/2-3p44p 2D3/2), 473.59 nm (3p44s 4P5/2-3p44p 4P3/2), 476.49 nm (3p44s 2P1/2-3p44p 2P3/2), 480.60 nm (3p44s 4P5/2-3p44p 4P5/2) are recorded using a high resolution visible spectrometer. Also, a VUV spectrometer has been used to simultaneously observe Ar13+ line emission at 18.79 nm (2s22p 2P3/2-2s2p2 2P3/2) and Ar14+ line emission at 22.11 nm (2s2 1S0-2s2p 1P1). The diffusivity and convective velocity of Ar are obtained by comparing the measured radial emissivity profile of Ar1+ emission and the line intensity ratio of Ar13+ and Ar14+ ions, with those simulated using the impurity transport code, STRAHL. Argon diffusivities ~ 12 m2/s and ~ 0.3 m2/s have been observed in the edge (ρ > 0.85) and core region of the Aditya-U, respectively. The diffusivity values both in the edge and core region are found to be higher than the neo-classical values suggesting that the argon impurity transport is mainly anomalous in the Aditya-U tokamak. Also, an inward pinch of ~ 10 m/s mainly driven by Ware pinch is required to match the measured and simulated data. The measured peaked profile of Ar density suggests impurity accumulation in these discharges.

4.
Kathmandu Univ Med J (KUMJ) ; 21(82): 170-174, 2023.
Article in English | MEDLINE | ID: mdl-38628010

ABSTRACT

Background Coronary artery disease (CAD) is a leading cause of death worldwide and is primarily caused by atherosclerosis. Carotid plaque and coronary artery disease share a common pathogenesis and risk factor. Carotid arteries are accessible through noninvasive imaging method. By characterizing the carotid arteries, it becomes possible to estimate the total burden of atherosclerosis, including that of coronary artery disease. According European Society of Cardiology (ESC) ultrasound of the carotid arteries should be considered, and be performed to detect plaque in patients with suspected chronic coronary syndrome. Objective To establish a relationship between coronary artery disease and carotid plaque. Method It is a cross sectional analytical study. Patients who underwent coronary angiogram at Dhulikhel Hospital from 1st April 2022 till 31st March 2023 were assessed for carotid plaque using carotid ultrasound. Chi square test was done to find the relationship between presence of carotid plaque and coronary artery stenosis of more than 50%. Positive predictive value and negative predictive value was calculated. Result Total number patient was 254 and the mean age was 61± 4.7 years. Out of which 85(33.5) had normal coronary artery, 143(56.3) had ≥ 50% stenosis and 120 (47.2) had ≥ 70% stenosis. Eight patients also had significant left main disease with ≥ 50 % stenosis. Carotid plaque was present in 121(47.6) patients. Out of 143 patients who had ≥ 50% stenosis in coronary angiogram, 104(72.7) patients also had carotid plaque which is statistically significant as p < 0.05. Positive predictive value (PPV) was 72.7% and negative predictive value was 84.7%. Conclusion This study establishes a relationship between coronary artery disease and carotid plaque, suggesting that the presence of carotid plaque may serve as an indicator of underlying coronary artery disease.


Subject(s)
Atherosclerosis , Coronary Artery Disease , Plaque, Atherosclerotic , Humans , Middle Aged , Aged , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/pathology , Constriction, Pathologic , Cross-Sectional Studies , Plaque, Atherosclerotic/diagnostic imaging , Plaque, Atherosclerotic/pathology , Carotid Arteries/pathology , Coronary Angiography/methods , Risk Factors , Predictive Value of Tests , Atherosclerosis/pathology
5.
Rev Sci Instrum ; 93(11): 113552, 2022 Nov 01.
Article in English | MEDLINE | ID: mdl-36461425

ABSTRACT

Spectroscopy in vacuum ultraviolet (VUV) and visible ranges plays an important role in the investigation and diagnosis of tokamak plasmas. However, under harsh environmental conditions of fusion grade devices, such as ITER, VUV-visible systems encounter many issues due to the degradation of optical components used in such systems. Here, near-infrared (NIR) spectroscopy has become an effective tool in understanding the edge plasma dynamics. Considering its importance, a NIR spectroscopic diagnostic has been developed and installed on the ADITYA-U tokamak. The system consists of a 0.5 m spectrometer having three gratings with different groove densities, and it is coupled with a linear InGaAs photodiode array. Radiation from the ADITYA-U edge plasma has been collected using a collimating lens and optical fiber combination and transported to the spectrometer. The spectrum in the NIR range from the ADITYA-U plasma has been recorded using this system, in which Paß and Paγ along with many spectral lines from neutral and singly ionized impurities have been observed. The influxes of H and C have been estimated from measurements. The H influx value is found to be 2.8 × 1016 and 1.9 × 1016 particles cm-2 s-1 from neutral hydrogen lines Hα and Paß, respectively, and the C influx value is found to be 3.5 × 1015 and 2.9 × 1015 particles cm-2 s-1 from the neutral carbon and singly ionized carbon, respectively. A good agreement is seen between these results and the results obtained by using a routine photomultiplier tube based diagnostic.

6.
Rev Sci Instrum ; 93(11): 113548, 2022 Nov 01.
Article in English | MEDLINE | ID: mdl-36461494

ABSTRACT

A Fast Visible Imaging Diagnostic (FVID) system, measuring the visible light emission spectrum (400-1000 nm) from tokamak plasma, has been installed on the Aditya-U tokamak to monitor the two-dimensional dynamics of the poloidal cross section of the plasma. In this work, we present the design and installation of the FVID system on the Aditya-U tokamak. The evolution of plasma and plasma-wall interactions is described. The signature of the runaway electron beam in visible imaging and its correlation with other diagnostics is presented. The estimation of the electron cyclotron resonance layer position during pre-ionization is also discussed in this work.

7.
Rev Sci Instrum ; 93(11): 113529, 2022 Nov 01.
Article in English | MEDLINE | ID: mdl-36461525

ABSTRACT

Nascent observations about the influence of kinetic instabilities on electron cyclotron emission (ECE) from runaway electrons (REs) have been detected and explored at the Aditya-Upgrade (Aditya-U) tokamak. The developed broadband ECE radiometer system offers wideband measurements by integrating several radio frequency units with a fixed intermediate frequency receiver with multiple channels, which is a novel approach to meet the needs of the localized measurements at various toroidal fields and extend the system dynamic range. The low density (ne ≤ 1 × 10-19 m-3) plasma discharges at Aditya-U are consistently accompanied by a 20%-40% increase in the ECE radiometer signal amplitude within 100 µs and sporadic step-like modulations. The Pitch Angle Scattering (PAS) of REs induced by kinetic instabilities is a potential candidate for their occurrence. This steep jump in the radiometer signals was detected due to its high temporal resolution of 10 µs. A "PREDICT" code that employs the relativistic test particle model validates these experimental findings of the radiometer diagnostic for the first time for Aditya-U tokamak. Preliminary observations of the ECE radiometer signals also show that additional gas puffs can be used to vary the trigger timings of such PAS events or even lead to their complete avoidance.

8.
Rev Sci Instrum ; 93(9): 093512, 2022 Sep 01.
Article in English | MEDLINE | ID: mdl-36182481

ABSTRACT

Runaway electrons (REs) are passively studied by hard x-ray (HX) emissions generated by REs. A LaBr3(Ce) detector-based HX spectroscopic diagnostic (operational within ∼75 keV to 3.5 MeV) has been set up on the ADITYA-U. The diagnostic acquisition software utility is upgraded to obtain the temporal evolution of the HX spectrum to understand the RE energy distribution in plasma during its various phases. The peak position moves to lower energy for Ohmically heated discharges (200-80 keV), indicating a relative increase in the thermal particle content in the plasma. The peak position of RE energy shows a decreasing tendency with increasing ne with Ne gas puffing and termination of the electron cyclotron resonance pulse.

9.
Kathmandu Univ Med J (KUMJ) ; 20(79): 351-358, 2022.
Article in English | MEDLINE | ID: mdl-37042379

ABSTRACT

Background Point prevalence survey (PPS) on antibiotic use developed by the WHO has already been used in many hospitals globally. Objective To obtain information on antibiotic prescribtion using point prevalence survey methodology in six private hospitals in the Kathmandu valley. Method This descriptive cross-sectional study was completed during 20th July to 28th July 2021 using point prevalence survey methodology. The study was conducted among inpatients admitted at or before 8:00 AM on the day of survey in various wards. Data was presented as frequencies and percentages. Result Maximum number of patients were above 60 years [34 (18.7%)]. Number of male and female participants were equal [91 (50%)]. Only one antibiotic was used in 81 patients (44.5%) followed by two antibiotics in 71 (39%) patients. Duration of prophylactic antibiotic use was one day in 66 (63.7%) patients. Blood, urine, sputum, and wound swabs were the common samples for culture. Cultures were positive for 17 (24.7%) samples. The common organisms isolated were E. Coli, Pseudomonas aeruginosa and Klebsiella pneumoniae. Ceftriaxone was the most used antibiotic. Drug and therapeutics, infection control committee and pharmacovigilance activities were present in 3/6 (50%) study sites. Antimicrobial stewardship was present in 3/6 (50%) and microbiological services was present in all hospitals. Antibiotic formulary and antibiotic guideline were present in 4/6 sites and facilities to audit or review surgical antibiotic prophylaxis choice in 2/6 (33.3%) sites, facility to monitor antibiotic use in 4/6 (66.6%) and cumulative antibiotic susceptibility reports in 2/6 (33.3%) study sites. Conclusion Ceftriaxone was the most used antibiotic. E. Coli, Pseudomonas aeruginosa and Klebsiella pneumonia were the commonly isolated organisms. Not all parameters for infrastructure, policy and practice and monitoring and feedback were present at the study sites. KEY WORDS.


Subject(s)
Anti-Bacterial Agents , Escherichia coli , Humans , Male , Female , Anti-Bacterial Agents/therapeutic use , Cross-Sectional Studies , Tertiary Care Centers , Ceftriaxone , Prevalence , Nepal/epidemiology
10.
Article in English | MEDLINE | ID: mdl-36798522

ABSTRACT

Background: COVID-19 disease, a pandemic for more than two years, has major morbidity and mortality related to pulmonary involvement. Chest radiography is the main imaging tool for critically ill patients. As the availability of arterial blood gas analysis is limited in the Level I and II healthcare centres, which are major partners in providing healthcare in resource-limited times, we planned the present study. Objectives: To assess the role of chest radiography in predicting the need for oxygen/ventilator support in critically ill COVID-19 patients. Methods: This hospital-based, retrospective study included 135 patients who needed oxygen/ventilator support and had optimal-quality chest radiographs at admission. All the chest X-rays were evaluated and a severity score was calculated on a predesigned pro forma. Statistical evaluation of the data obtained was done using appropriate tools and methods. Results: Males outnumbered females, with a mean age of 54.35 ± 14.49 years. More than 72% of patients included in our study needed ventilator support while the rest needed oxygen support. There was a significant statistical correlation between the chest radiograph severity score and SPO2 /PaO2 levels in our study. Using a cut-off value >8 for the chest radiograph severity score in predicting the need for ventilator support in a Covid-19 patient, the sensitivity, specificity and accuracy was 85.7%, 92.5% and 89.5%, respectively. Conclusion: Chest radiography remains the mainstay of imaging in critically ill COVID-19 patients when they are on multiple life-support systems. Though arterial blood gas analysis is the gold standard tool for assessing the need for oxygen/ventilator support in these patients, the severity score obtained from the initial chest radiograph at the time of admission may also be used as a screening tool. Chest radiography may predict the need for oxygen/ventilator support, allowing time for patients to be moved to an appropriate-level healthcare centre, thus limiting morbidity and mortality.

11.
Musculoskelet Surg ; 106(4): 371-382, 2022 Dec.
Article in English | MEDLINE | ID: mdl-33982208

ABSTRACT

BACKGROUND: Although radiographs have been widely used in the evaluation of patients with suspected bone tumors, the lack of an objective radiological assessment method leads to a challenge in reaching correct diagnosis. The study aimed to propose a Radiological Evaluation Score for Bone Tumors (REST) which includes eight radiological factors [characteristics, content, cortical breach, distinctiveness, distribution, periosteal reaction, fracture, and soft tissue swelling] to form a single score along with its validation by multidisciplinary observers. METHODS: We reviewed the radiographs of 100 patients with a primary bone tumor which were selected at random from the database between January 2017 and January 2019 of a tertiary cancer center. Four reviewers (two orthopedic oncologists and two surgical oncologists) independently assessed the radiographs, based on the reporting system of REST. We constituted two groups according to the probable diagnosis of bone tumor (suspected benign tumor and suspected malignant tumor). RESULTS: The mean score in the suspected benign tumor group was 1.1 (range 0-3, 95% CI 0.8-1.3) and in malignant tumor group was 6.1 (range 2-8, 95% CI 5.8-6.4). A receiver operator characteristic (ROC) curve for REST was with a cutoff of 3.5, with the most diagnostic value area under curve (AUC) of 0.99. The sensitivity was 98% and specificity was 100% with a positive predictive value of 100% and a negative predictive value of 98%. The inter-observer correlation coefficient was 0.985 (p value < 0.05), and Fleiss kappa value for the prediction of the benign or malignant lesion was 0.97 (p value < 0.05). The characteristics and content of tumor, cortical erosion, distinctiveness, distribution, periosteal reaction, and soft tissue mass had a significant correlation with the aggressiveness of bone lesion p value < 0.05. CONCLUSIONS: The Radiological Evaluation Score for Bone Tumors (REST) is a structured reporting and objective method for the assessment of radiographs in patients with suspected bone tumors. This method is a reliable and helpful tool for clinicians in their outdoor patient department to differentiate a radiograph of a suspected benign tumor from a malignant bone tumor.


Subject(s)
Bone Neoplasms , Humans , Bone Neoplasms/diagnosis , Radiography , Predictive Value of Tests , Retrospective Studies
13.
Kathmandu Univ Med J (KUMJ) ; 20(80): 417-421, 2022.
Article in English | MEDLINE | ID: mdl-37795715

ABSTRACT

Background Urinary albumin excretion has been associated to cardiovascular events and increased mortality in hypertensive patients. There is limited information among Nepalese patients about the implications of microalbuminuria (MA) in the setting of hypertension and potential cardiovascular morbidity. Objective To investigate the prevalence of microalbuminuria in patients with essential hypertension and its connection with left ventricular hypertrophy (LVH) and carotid artery intima-media thickness (cIMT). Method The study involved 80 hypertension individuals in total. All patients in the study had basic biochemical tests, routine urine evaluations, echocardiography, and carotid artery intima-media thickness measurements performed, and the data were analyzed. Result The prevalence of microalbuminuria was present in 37.5% cases of essential hypertension. The mean left ventricular mass index (LVMI) was significantly higher in patients with increased microalbuminuria as compared to patient with normal microalbuminuria. In addition, a significant positive correlation between microalbuminuria and left ventricular hypertrophy was also observed. Furthermore, mean carotid artery intima-media thickness was found to be higher in patients with microalbuminuria (p < 0.001), with 76.7% of the patients with microalbuminuria having elevated mean carotid artery intima-media thickness. The carotid artery intima-media thickness had a positive correlation with both microalbuminuria and left ventricular hypertrophy. Conclusion Microalbuminuria assessment in hypertensive patients is an important test for the evaluation of target organ damage. This study shows that microalbuminuria is common in hypertension patients, particularly those with left ventricular hypertrophy. Microalbuminuria was found to be associated with left ventricular hypertrophy and carotid artery intima-media thickness.


Subject(s)
Carotid Intima-Media Thickness , Hypertension , Humans , Hypertrophy, Left Ventricular/diagnostic imaging , Hypertrophy, Left Ventricular/epidemiology , Hypertrophy, Left Ventricular/complications , Prevalence , Risk Factors , Essential Hypertension/complications , Hypertension/complications , Hypertension/epidemiology , Albuminuria/epidemiology , Albuminuria/complications , Carotid Arteries/diagnostic imaging
14.
Radiography (Lond) ; 27(3): 823-830, 2021 08.
Article in English | MEDLINE | ID: mdl-33487526

ABSTRACT

INTRODUCTION: We propose a ''A to Z RAM (Radiograph Assessment Method)'' for evaluation of Radiograph of patients with a suspected bone tumour. METHODS: In the current study, ten radiological features with letters 'A, B, C, D, E, F and Z' were used and which included the age of the patient, involved part of the bone, characteristics, content, distinctiveness, the exterior of the bone, fracture, and zone of transition. Four independent observers (orthopaedic oncologists and surgical oncologists) evaluated a set of 30 radiographs of bone tumour selected at random from our hospital database based on A to Z RAM. We classified the lesions into two groups according to the traffic signal system; Green (suspected benign lesion) and Red (suspected malignant lesion). RESULTS: There were 18 (60%) benign bone lesions and 12 (40%) malignant lesions in the current study. 91.6% of malignant tumours and 88.8% of the benign tumours were identified correctly by the four observers. The inter-observer variability with Fleiss kappa was 0.884 (95% CI 0.7-1.03 p-value < 0.05), suggestive of agreement not by chance. These radiographs were again reassessed by the four observers after 3 months. The interobserver variability by Fleiss kappa was 1.0 (95% CI 0.8-1.1) suggesting complete agreement amongst the observers. Both orthopaedic oncologists had intra-observer kappa as 1.0 each and both surgical oncologists had 0.795 and 0.930 respectively. CONCLUSION: The proposed A to Z RAM is an easy to use and reproducible method for reviewing radiographs in the out-patient department along with clinical findings for better management of patients with suspected bone lesions. The A to Z RAM can be a medical triage tool and subdivide bone lesions into two subgroups i.e. suspected benign lesion with a suggestion of further investigations with MRI and biopsy and suspected malignant lesion with a suggestion of MRI or early referral to a tertiary cancer center with expertise in orthopaedic oncology. IMPLICATIONS FOR PRACTICE: The A to Z RAM (Radiologic Assessment Method) is a reproducible method for reviewing radiographs in the out-patient department and can be an aid for better management of patients. A to Z RAM is useful as a medical triage system, subdividing patients according to the probable diagnosis into a suspected benign lesion and suspected malignant lesion.


Subject(s)
Bone Neoplasms , Fractures, Bone , Bone Neoplasms/diagnostic imaging , Humans , Observer Variation , Radiography , Triage
15.
Kathmandu Univ Med J (KUMJ) ; 19(76): 410-414, 2021.
Article in English | MEDLINE | ID: mdl-36259180

ABSTRACT

Background Patients with diabetes mellitus have a higher prevalence of atherosclerotic heart disease and a higher incidence of myocardial infarction than the general population. Definitive diagnosis and precise assessment of anatomic severity of Coronary Artery Disease requires invasive diagnostic modality like coronary angiography. Objective To study angiographic characteristics and severity involving coronary arteries in patients with acute ST segment elevation Myocardial infarction and to compare the same in diabetics and non-diabetics. Method Among 150 patients with acute coronary syndrome, 75 diabetics and 75 nondiabetics admitted in Manmohan Cardiothoracic vascular and transplant Centre were selected randomly during a period of one year formed the study group. Random Blood Sugar, Fasting Blood Sugar was done in all 150 patients, HbA1c in all diabetics. All subjects with acute ST Elevation Myocardial Infarction were taken up for coronary angiography intended for primary PCI. Result In our study, 35 (46.7%) out of 75 diabetic patients had triple or multi-vessel disease compared to 10 (13.4%) out of 75 non diabetics. Non-diabetic patients had significantly higher single vessel disease (65.3%). There was a statistically significant association of duration of DM with vessels involved. The occurrence of Triple Vessel Disease/Multivessel Disease was significantly higher in the patients with DM duration > 10 years compared to patients with DM duration < 10 years (64.7% vs. 35.3%, P < 0.001), however there was no significant difference in type of vessel involved. Similarly, a significantly higher proportion of Triple vessel disease was observed in patients with poor glycemic control (HbA1c > 8.5%). 72.2% of the patients with HbA1c > 8.5% had Triple vessel disease/Multi vessel disease, whereas patients with good glycemic control (HbA1c < 7.0%) had predominantly Single vessel disease (90.0%), with no occurrence of Triple vessel disease/Multi vessel disease Conclusion Diabetic patients presenting with ST Elevation Myocardial Infarction are likely to have triple/multiple vessel disease compared to non-diabetic patients. The occurrence of Triple Vessel Disease/Multivessel Disease was significantly higher in the patients with DM duration > 10 years compared to patients with DM duration <10 years.


Subject(s)
Coronary Artery Disease , Diabetes Mellitus , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Coronary Artery Disease/complications , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/epidemiology , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/epidemiology , Percutaneous Coronary Intervention/methods , Glycated Hemoglobin , Tertiary Care Centers , Nepal/epidemiology , Blood Glucose , Coronary Angiography , Diabetes Mellitus/epidemiology , Treatment Outcome
16.
Ann R Coll Surg Engl ; 102(9): 663-671, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32808799

ABSTRACT

INTRODUCTION: Evidence suggests that midline incisions should be closed with the small-bite technique to reduce IH formation. No recommendations exist for the closure of transverse incisions used in hepatobiliary surgery. This work systematically summarises rates of IH formation and associated technical factors for these transverse incisions. METHODS: A systematic search was undertaken. Studies describing the incidence of IH were included. Incisions were classified as transverse (two incision types) or hybrid (transverse with midline extension, comprising five incision types). The primary outcome measure was the pooled proportion of IH. Subgroup analysis based on minimum follow-up of two years and a priori definition of IH with clinical and radiological diagnosis was undertaken. FINDINGS: Thirteen studies were identified and included 5,427 patients; 1,427 patients (26.3%) underwent surgery for benign conditions, 3,465 (63.8%) for malignancy and 535 (9.9%) for conditions that were not stated or classified as 'other'. The pooled incidence of IH was 6.0% (2.0-10.0%) at a weighted mean follow-up of 17.5 months in the transverse group, compared with 15.0% (11.0-19.0%) at a weighted mean follow-up of 42.0 months in the hybrid group (p = 0.045). Subgroup analysis did not demonstrate a statistical difference in IH formation between the hybrid versus transverse groups. CONCLUSION: Owing to the limitations in study design and heterogeneity, there is limited evidence to guide incision choice and methods of closure in hepatopancreatobiliary surgery. There is an urgent need for a high-quality prospective cohort study to understand the techniques used and their outcomes, to inform future research.


Subject(s)
Digestive System Diseases/surgery , Incisional Hernia/etiology , Biliary Tract Surgical Procedures/adverse effects , Cholecystectomy/adverse effects , Cholecystectomy/methods , Humans , Liver/surgery , Liver Transplantation/adverse effects
18.
EClinicalMedicine ; 21: 100303, 2020 Apr.
Article in English | MEDLINE | ID: mdl-32280940

ABSTRACT

BACKGROUND: Daily oral TDF/FTC is protective against HIV infection when used for pre-exposure prophylaxis (PrEP). However, daily adherence to oral PrEP is difficult for many; therefore, finding alternative PrEP strategies remains a priority. HPTN 076 evaluated the long-acting injectable form of rilpivirine (RPV), known as RPV LA for safety, pharmacokinetics and acceptability. METHODS: HPTN 076 (NTC 02165202) was a phase 2, double-blind, 2:1 randomized trial comparing the safety of 1200mg RPV LA (LA) to placebo (P). The study included a 28-day oral run-in phase of daily, self- administered oral RPV (25 mg), with directly observed oral dosing about six times. Of 136 enrolled sexually active, HIV-uninfected, low HIV-risk African (100) and US (36) adult women, injectable product was administered in two gluteal, intramuscular (IM) injections once every eight weeks to 122 participants following the oral run-in phase. A maximum of six injection time points occurred over a 48-week period. Acceptability, safety, tolerability and pharmacokinetic (PK) data were collected throughout the study. This paper includes primary endpoint data collected up to the week 52 post enrollment. FINDINGS: The median age of the enrolled population was 31 years (IQR: 25,38), median weight 75 kg (IQR: 64, 89), median body mass index (BMI) 30 (IQR: 27, 35), 46% married, 94% Black and 60% unemployed. A total of 122 (80 LA, 42 P) women received at least one injection and 98 (64 LA, 34 P) received all six injections. During the injection phase, three women withdrew from the study (2 LA, 1 P) and 16 women discontinued study product (10 LA, 6 P). Fourteen women (11 LA and 3 P) discontinued oral study product and did not enter the injection phase. Study product discontinuations were not significantly different between the two arms throughout. Of the product discontinuations in the injection phase, 8% in LA and 5% in P arm were due to adverse events (AEs), including one randomized to the P arm with prolonged QTc interval on EKG. The proportion of women who experienced Grade 2 or higher AEs during the injection phase as the primary outcome was not significantly different between the two arms [73.8%, 95% CI: (63.2%, 82.1%) for LA and 73.8%, 95% CI: (58.9%, 84.7%), p>0.99]. Transient Grade ≥2 liver abnormalities occurred in 14% of women in the LA arm compared with 12% in P arm. Three LA women (4%) developed Grade 3 injection site reactions compared with none in P arm. In participants who received at least 1 injection, the geometric mean of overall RPV trough concentrations (Ctrough) was 62.2 ng/mL. In participants who received all six injections, the geometric mean of CTrough through the injection phase and after the last injection were 72.8 ng/mL and 100.9 ng/mL, respectively. At week 52 (eight weeks after last injection), the geometric mean of RPV Ctrough was 75.0 ng/mL. At the last injection visit (Week 44), 80 % of women who answered acceptability questions strongly agreed that they would think about using- and 68% that they would definitely use a PrEP injectable in the future. INTERPRETATION: RPV LA IM injections every eight weeks in African and US women were safe and acceptable. Overall, despite more injection site reactions and pain in the participants receiving RPV LA the injections were well tolerated. Data from this study support the further development of injectable PrEP agents.

19.
BJS Open ; 3(4): 429-435, 2019 08.
Article in English | MEDLINE | ID: mdl-31406956

ABSTRACT

Background: Inguinal hernias are common in less economically developed countries (LEDCs), and associated with significant morbidity and mortality. Tension-free mesh repair is the standard treatment worldwide. Lack of resources combined with the high cost of commercial synthetic mesh (CSM) have limited its use in LEDCs. Sterilized mosquito net mesh (MNM) has emerged as a low-cost, readily available alternative to CSM. The aim of this systematic review and meta-analysis was to evaluate the safety and efficacy of MNM for the use in hernia repair in LEDCs. Methods: A systematic review and data meta-analysis of all published articles from inception to August 2018 was performed. Cochrane Central Register of Controlled Trials, MEDLINE and Embase databases were searched. The primary outcome measure was the overall postoperative complication rate of hernia repair when using MNM. Secondary outcome measures were comparisons between MNM and CSM with regard to overall complication rate, wound infection, chronic pain and haematoma formation. Results: A total of nine studies were considered relevant (3 RCTs, 1 non-randomized trial and 5 prospective studies), providing a total cohort of 1085 patients using MNM. The overall complication rate for hernia repair using MNM was 9·3 per cent. There was no significant difference between MNM and CSM regarding the overall postoperative complication rate (odds ratio 0·99, 95 per cent c.i. 0·65 to 1·53; P = 0·98), severe or chronic pain (OR 2·52, 0·36 to 17·42; P = 0·35), infection (OR 0·56, 0·19 to 1·61; P = 0·28) or haematoma (OR 1·05, 0·62 to 1·78; P = 0·86). Conclusion: MNM has a low overall postoperative complication rate and is unlikely to be inferior to CSM in terms of safety and efficacy. MNM is a suitable low-cost alternative to CSM in the presence of financial constraint.


Subject(s)
Hernia, Inguinal/surgery , Herniorrhaphy , Mosquito Nets , Surgical Mesh , Developing Countries , Herniorrhaphy/economics , Herniorrhaphy/instrumentation , Humans , Postoperative Complications/epidemiology , Poverty , Surgical Mesh/adverse effects , Surgical Mesh/economics , Surgical Mesh/statistics & numerical data , Treatment Outcome
20.
Ann R Coll Surg Engl ; 101(6): 428-431, 2019 Jul.
Article in English | MEDLINE | ID: mdl-31155897

ABSTRACT

INTRODUCTION: Intraoperative cholangiography is sporadically used in patients undergoing laparoscopic cholecystectomy to delineate common bile duct anatomy and exclude retained stones. In patients with acute gallstone pancreatitis, intraoperative cholangiography may reduce the need for preoperative magnetic resonance cholangiopancreatography. MATERIALS AND METHODS: A retrospective review of a prospectively collected patient database was undertaken over a 15-year period. The primary objective was to evaluate intraoperative assessment of the common bile duct with intraoperative cholangiography in patients with acute gallstone pancreatitis. RESULTS: A total of 2215 patients underwent laparoscopic cholecystectomy between October 1998 and December 2013; 113 patients (of whom 77 were women) with a mean age of 54 years (range 16-88 years) were diagnosed with acute gallstone pancreatitis. Of these, 102 patients (90%) underwent laparoscopic cholecystectomy with intraoperative cholangiography, which was normal in 89 cases. Thirteen patients had choledocholithiasis on intraoperative cholangiography, 11 of whom were managed with concomitant trans-cystic duct exploration and clearance. Two patients required postoperative endoscopic retrograde cholangiopancreatography. CONCLUSIONS: In patients diagnosed with acute gallstone pancreatitis, it is reasonable to proceed directly to surgery using intraoperative cholangiography on the same admission as the definitive assessment of the common bile duct. This negates the need for magnetic resonance cholangiopancreatography and can translate into cost savings and reduced length of stay.


Subject(s)
Cholangiography , Cholangiopancreatography, Magnetic Resonance , Cholecystectomy, Laparoscopic/methods , Gallstones/surgery , Pancreatitis/surgery , Acute Disease , Adolescent , Adult , Aged , Aged, 80 and over , Common Bile Duct/diagnostic imaging , Female , Gallstones/diagnostic imaging , Humans , Intraoperative Period , Male , Middle Aged , Pancreatitis/diagnostic imaging , Retrospective Studies , Young Adult
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