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Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial.
No full textBACKGROUND
A shift towards parenchymal-sparing liver resections in open and laparoscopic surgery emerged in the last few years. Laparoscopic liver resection is technically feasible and safe, and consensus guidelines acknowledge the laparoscopic approach in the posterosuperior segments. Lesions situated in these segments are considered the most challenging for the laparoscopic approach. The aim of this trial is to compare the postoperative time to functional recovery, complications, oncological safety, quality of life, survival and costs after laparoscopic versus open parenchymal-sparing liver resections in the posterosuperior liver segments within an enhanced recovery setting.
METHODS
The ORANGE Segments trial is an international multicentre randomised controlled superiority trial conducted in centres experienced in laparoscopic liver resection. Eligible patients for minor resections in the posterosuperior segments will be randomised in a 1:1 ratio to undergo laparoscopic or open resections in an enhanced recovery setting. Patients and ward personnel are blinded to the treatment allocation until postoperative day 4 using a large abdominal dressing. The primary endpoint is time to functional recovery. Secondary endpoints include intraoperative outcomes, length of stay, resection margin, postoperative complications, 90-day mortality, time to adjuvant chemotherapy initiation, quality of life and overall survival. Laparoscopic liver surgery of the posterosuperior segments is hypothesised to reduce time to functional recovery by 2 days in comparison with open surgery. With a power of 80% and alpha of 0.04 to adjust for interim analysis halfway the trial, a total of 250 patients are required to be randomised.
DISCUSSION
The ORANGE Segments trial is the first multicentre international randomised controlled study to compare short- and long-term surgical and oncological outcomes of laparoscopic and open resections in the posterosuperior segments within an enhanced recovery programme.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03270917 . Registered on September 1, 2017. Before start of inclusion.
PROTOCOL VERSION
version 12, May 9, 2017
Comparative Study of Bupivacaine-Fentanyl versus Ropivacaine-Fentanyl for Epidural Analgesia in Labor.
No full textBackground
Labor pain is one of the most intense pains that a woman experiences. Almost 60% of primiparous women described the pain of uterine contractions as unbearable extremely severe or excruciating.
Aims
Our study aimed to relieve pain suffering of mother and to decrease fetal acidosis to make the delivery process safer for mother and baby.
Settings and Design
Thus, epidural labor analgesia was designed comparing ropivacaine-fentanyl (RF) and bupivacaine-fentanyl (BF) as intermittent bolus technique.
Materials and Methods
Sixty women who requested epidural analgesia having ≥3 cm cervical dilatation were allocated in two groups, one group received RF and the other group received BF. Each group received study drug 16 mL with 50 μg fentanyl and top of 10 mL and 25 μg fentanyl when visual analog scale (VAS) ≥3. The efficacy of analgesia, adverse effects, and obstetric and neonatal outcomes were compared.
Statistical Analysis
For skewed data or ordered categorical data, nonparametric Mann-Whitney -test was used for statistical analysis of two groups. For categorical data, comparisons were made by Pearson's Chi-square test or Fisher's exact test as appropriate (%).
Results
Both groups were comparable in terms of demographic data and obstetric and neonatal parameters at the onset of labor Comparison of heart rate, systolic blood pressure (BP), diastolic BP, and saturation between Group RF and Group BF. It was found statistically not significant. VAS score before the epidural study drug was given, was 5 (4-5) in RF group, and was 5 (3-6) in BF group, and after 1 min, VAS score was 1 in both the groups thereafter. The score remained zero till at 100 min in both the groups till the time when the top-up dose was given. Bearing down reflex was present in all the patients as judged by the obstetrician. It was sluggish in 20% of patients in Group RF as compared to 10% in Group BF.
Conclusions
From clinical and safety perspective, both RF and BF were reasonable choice for labor analgesia
Follow-up of patients with retroperitoneal sarcoma.
No full textRetroperitoneal sarcomas (RPS) are rare malignancies that are potentially curable by complete surgical resection. A regular surveillance program is normally commenced following surgery due to the risk of local recurrence (LR), especially in low-intermediate grade disease, and distant metastases (DM), especially in high-grade RPS. Consensus guidelines usually advocate for more frequent imaging during the first 2-3 years and less intensive imaging over a prolonged period thereafter, reflecting the incidence pattern of LR and DM. Definitive evidence for the most effective imaging schedule has never been provided, and retrospective studies have not shown an association between follow-up intensity and survival. Improvement in the prediction of recurrence patterns has been sustained by prognostic dynamic nomograms, which are now capable of forecasting disease behaviour in each patient according to specific features. Incorporation of such tools in clinical practice may help to stratify patients and tailor ongoing surveillance to the risk of recurrence. This may help to relieve patients' anxiety while awaiting results of surveillance investigations, and also reduce the economic and environmental burden of repeated imaging. A randomized controlled study (SARveillance Trial) is proposed to shed light on this controversial topic, allowing clinicians to harmonize the follow-up protocol of patients undergoing surgery for RPS
High risk factors for craniosynostosis during pregnancy: A case-control study.
No full textBackground
Craniosynostosis is a birth defect involving premature cranial sutures' fusion with an increasing prevalence and unknown underlying causes in nearly 80% of cases. The current study investigates a series of high-risk factors associated with a non-syndromic craniosynostosis.
Methods
Ninety-seven (97) children were included in the retrospective case-control study, 62 controls and 35 with craniosynostosis. A questionnaire with 143 questions was used in face-to-face interviews. After univariate analyses, stepwise multivariate logistic regression analysis was implemented.
Results
In craniosynostosis group, 3 out of 4 were male subjects and 2 out of 3 born with caesarian section. History for central nervous system abnormalities in their younger siblings, low birth weight, extended use of mobile phone from the parents and medications' use differed significantly between craniosynostosis and control group. After adjustment for all factors, only maternal medication use (aOR 6,1 [2.1 - 19], CI 95%) and oral progesterone intake (aOR 4 [1.2 - 14], CI 95%) were significantly associated with an increased risk in craniosynostosis group.
Conclusion
The maternal medications' use and particular oral progesterone intake is associated with an increased risk for non-syndromic craniosynostosis. However, due to the study's limitations, further research is warranted
An evidence-based surveillance tool to identify and report catheter/cannula bloodstream infection in patients receiving parenteral nutrition.
No full textOBJECTIVE
Catheter/cannula-bloodstream infection (CBI) has been proposed as a marker of the quality of care provided to patients receiving parenteral nutrition (PN). However, surveillance criteria for CBI are variable, inconsistent, and sometimes confusing and impractical. Surveillance criteria were developed to simply and accurately demonstrate the presence or absence of CBI. The aim of this study was to establish a simple and valid surveillance tool, with consideration of changes in vital signs, to identify CBI in patients receiving PN.
METHODS
Adult (≥18 y) inpatients prescribed PN at a single large teaching hospital were recruited between October 11, 2017 and November 16, 2018. Common clinical and laboratory criteria, including blood culture, associated with 100 consecutive PN episodes associated with suspected CBI were examined for potential predictive markers of CBI. Using binary logistic regression, criteria were incorporated into an instrument that was validated against a reference classification of CBI established by an expert multidisciplinary group.
RESULTS
The reference classification comprised 12 PN episodes with CBI and 88 without. Abnormal vital signs did not significantly predict CBI, but resolution of fever (≥38°C) and low systolic blood pressure (<100 mm Hg) in response to a specific treatment for CBI (line removal/antibiotics) did. Two other criteria were also significant predictors: positive blood culture; and absence of an alternative source that could explain the septic episode other than the catheter/cannula supplying PN. These two criteria together with a positive response to treatment (temperature and/or blood pressure, incorporated into a single binary variable), resulted in 100% correct CBI classification (100% sensitivity, 100% specificity, and 1.000 area under the curve in receiver operating characteristic analysis). All criteria could be retrospectively extracted from the medical records of all PN episodes.
CONCLUSION
A CBI tool shows promise as a surveillance instrument for benchmarking and interinstitutional comparisons of the care received by hospitalized patients given PN
Rearrangement processes and structural variations show evidence of selection in oesophageal adenocarcinomas.
No full textOesophageal adenocarcinoma (OAC) provides an ideal case study to characterize large-scale rearrangements. Using whole genome short-read sequencing of 383 cases, for which 214 had matched whole transcriptomes, we observed structural variations (SV) with a predominance of deletions, tandem duplications and inter-chromosome junctions that could be identified as LINE-1 mobile element (ME) insertions. Complex clusters of rearrangements resembling breakage-fusion-bridge cycles or extrachromosomal circular DNA accounted for 22% of complex SVs affecting known oncogenes. Counting SV events affecting known driver genes substantially increased the recurrence rates of these drivers. After excluding fragile sites, we identified 51 candidate new drivers in genomic regions disrupted by SVs, including ETV5, KAT6B and CLTC. RUNX1 was the most recurrently altered gene (24%), with many deletions inactivating the RUNT domain but preserved the reading frame, suggesting an altered protein product. These findings underscore the importance of identification of SV events in OAC with implications for targeted therapies
SARS-CoV-2 Vaccine Responses in Individuals with Antibody Deficiency: Findings from the COV-AD Study.
No full textBACKGROUND
Vaccination prevents severe morbidity and mortality from COVID-19 in the general population. The immunogenicity and efficacy of SARS-CoV-2 vaccines in patients with antibody deficiency is poorly understood.
OBJECTIVES
COVID-19 in patients with antibody deficiency (COV-AD) is a multi-site UK study that aims to determine the immune response to SARS-CoV-2 infection and vaccination in patients with primary or secondary antibody deficiency, a population that suffers from severe and recurrent infection and does not respond well to vaccination.
METHODS
Individuals on immunoglobulin replacement therapy or with an IgG less than 4 g/L receiving antibiotic prophylaxis were recruited from April 2021. Serological and cellular responses were determined using ELISA, live-virus neutralisation and interferon gamma release assays. SARS-CoV-2 infection and clearance were determined by PCR from serial nasopharyngeal swabs.
RESULTS
A total of 5.6% (n = 320) of the cohort reported prior SARS-CoV-2 infection, but only 0.3% remained PCR positive on study entry. Seropositivity, following two doses of SARS-CoV-2 vaccination, was 54.8% (n = 168) compared with 100% of healthy controls (n = 205). The magnitude of the antibody response and its neutralising capacity were both significantly reduced compared to controls. Participants vaccinated with the Pfizer/BioNTech vaccine were more likely to be seropositive (65.7% vs. 48.0%, p = 0.03) and have higher antibody levels compared with the AstraZeneca vaccine (IgGAM ratio 3.73 vs. 2.39, p = 0.0003). T cell responses post vaccination was demonstrable in 46.2% of participants and were associated with better antibody responses but there was no difference between the two vaccines. Eleven vaccine-breakthrough infections have occurred to date, 10 of them in recipients of the AstraZeneca vaccine.
CONCLUSION
SARS-CoV-2 vaccines demonstrate reduced immunogenicity in patients with antibody deficiency with evidence of vaccine breakthrough infection
Which pre-dilatation balloons provide the best lesion preparation prior to use of drug coated balloons in De Novo lesions? Results from the PREPARE study.
No full textBACKGROUND
There is a lack of data on the clinical outcomes following the use of different strategies for lesion preparation prior to the use of drug-coated balloons (DCB). In this study, we have explored the clinical outcomes between different types of pre-dilatation balloons: semicompliant (SB), non-compliant (NB) and scoring balloons (ScB) used when preparing denovo lesions prior to the use of DCB.
METHODS
We retrospectively evaluated all patients who underwent treatment with DCB for de-novo lesions between 2011-2019 at 4 high-volume European centres. The measured study endpoints were: cardiac-death, TV-MI, TLR and MACE.
RESULTS
During the study period, 553 patients were treated with DCB for de-novo lesions, 327 with SB only, 172 with NB and 54 with ScB. There were some differences in the procedural characteristics between the 3 groups. Pre-dilatation balloons were significantly larger in the ScB and NB groups as compared to the SB (2.7 mm and 2.6 mm vs. 2.3 mm; p< 0.001). The reference vessel diameter was significantly larger in the NB group as compared to the ScB and SB (2.6 mm vs. 2.2 mm and 2.3 mm; p<0.001). During the median follow-up duration of 547-days, there were no differences in the hard-clinical end-points, however, TLR was significantly higher in the ScB as compared to SB and NB group (11% vs. 3.4% and 4.7%; p=0.02).
CONCLUSIONS
The PREPARE study results do not suggest routine use of ScB prior to DCB in de novo lesions
Rate of pancreatic cancer following a negative endoscopic ultrasound and associated factors.
No full textBACKGROUND : Data are limited regarding pancreatic cancer diagnosed following a pancreaticobiliary endoscopic ultrasound (EUS) that does not diagnose pancreatic cancer. We have studied the frequency of, and factors associated with, post-EUS pancreatic cancer (PEPC) and 1-year mortality. METHODS : Between 2010 and 2017, patients with pancreatic cancer and a preceding pancreaticobiliary EUS were identified in a national cohort using Hospital Episode Statistics. Patients with a pancreaticobiliary EUS 6-18 months before a later pancreatic cancer diagnosis were the PEPC cases; controls were those with pancreatic cancer diagnosed within 6 months of pancreaticobiliary EUS. Multivariable logistic regression models examined the factors associated with PEPC and a Cox regression model examined factors associated with 1-year cumulative mortality. RESULTS : 9363 pancreatic cancer patients were studied; 93.5 % identified as controls (men 53.2 %; median age 68 [interquartile range (IQR) 61-75]); 6.5 % as PEPC cases (men 58.2 %; median age 69 [IQR 61-77]). PEPC was associated with older age (≥ 75 years compared with 5, OR 1.90, 95 %CI 1.49-2.43), chronic pancreatitis (OR 3.13, 95 %CI 2.50-3.92), and diabetes mellitus (OR 1.58, 95 %CI 1.31-1.90). Metal biliary stents (OR 0.57, 95 %CI 0.38-0.86) and EUS-FNA (OR 0.49, 95 %CI 0.41-0.58) were inversely associated with PEPC. PEPC was associated with a higher cumulative mortality at 1 year (hazard ratio 1.12, 95 %CI 1.02-1.24), with only 14 % of PEPC patients (95 %CI 12 %-17 %) having a surgical resection, compared with 21 % (95 %CI 20 %-22 %) of controls. CONCLUSIONS : PEPC occurred in 6.5 % of patients and was associated with chronic pancreatitis, older age, more co-morbidities, and specifically diabetes mellitus. PEPC was associated with a worse prognosis and lower surgical resection rates
Very low prevalence of ultrasound-detected tenosynovial abnormalities in healthy subjects throughout the age range: OMERACT ultrasound minimal disease study.
No full textOBJECTIVES
This study aimed to determine the prevalence of ultrasound-detected tendon abnormalities in healthy subjects (HS) across the age range.
METHODS
Adult HS (age 18-80 years) were recruited in 23 international Outcome Measures in Rheumatology ultrasound centres and were clinically assessed to exclude inflammatory diseases or overt osteoarthritis before undergoing a bilateral ultrasound examination of digit flexors (DFs) 1-5 and extensor carpi ulnaris (ECU) tendons to detect the presence of tenosynovial hypertrophy (TSH), tenosynovial power Doppler (TPD) and tenosynovial effusion (TEF), usually considered ultrasound signs of inflammatory diseases. A comparison cohort of patients with rheumatoid arthritis (RA) was taken from the Birmingham Early Arthritis early arthritis inception cohort.
RESULTS
939 HS and 144 patients with RA were included. The majority of HS (85%) had grade 0 for TSH, TPD and TEF in all DF and ECU tendons examined. There was a statistically significant difference in the proportion of TSH and TPD involvement between HS and subjects with RA (HS vs RA p<0.001). In HS, there was no difference in the presence of ultrasound abnormalities between age groups.
CONCLUSIONS
Ultrasound-detected TSH and TPD abnormalities are rare in HS and can be regarded as markers of active inflammatory disease, especially in newly presenting RA