A Prospective Observational Study to Determine Rate of Thromboprophylaxis in Oncology Patients Undergoing Abdominal or Pelvic Surgery.
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ABSTRACT: Supplementary information
The online version contains supplementary material available at 10.1007/s13193-021-01281-0.
SUBMITTER: Shrikhande SV
PROVIDER: S-EPMC8272769 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Introduction and hypothesisThe use of synthetic mesh in transvaginal pelvic floor surgery has been subject to debate internationally. Although mesh erosion appears to be less associated with an abdominal approach, the long-term outcome has not been studied intensively. This study was set up to determine the long-term mesh erosion rate following abdominal pelvic reconstructive surgery.MethodsA prospective, observational cohort study was conducted in a tertiary care setting. All consecutive female patients who underwent robot-assisted laparoscopic sacrocolpopexy and sacrocolporectopexy in 2011 and 2012 were included. Primary outcome was mesh erosion. Preoperative and postoperative evaluation (6 weeks, 1 year, 5 years) with a clinical examination and questionnaire regarding pelvic floor symptoms was performed. Mesh-related complications were assessed using a transparent vaginal speculum, proctoscopy, and digital vaginal and rectal examination. Kaplan-Meier estimates were calculated for mesh erosion. A review of the literature on mesh exposure after minimally invasive sacrocolpopexy was performed (?12 months' follow-up).ResultsNinety-six of the 130 patients included (73.8%) were clinically examined. Median follow-up time was 48.1 months (range 36.0-62.1). Three mesh erosions were diagnosed (3.1%; Kaplan-Meier 4.9%, 95% confidence interval 0-11.0): one bladder erosion for which mesh resection and an omental patch interposition were performed, and two asymptomatic vaginal erosions (at 42.7 and 42.3 months) treated with estrogen cream in one. Additionally, 22 patients responded solely by questionnaire and/or telephone; none reported mesh-related complaints. The literature, mostly based on retrospective studies, described a median mesh erosion rate of 1.9% (range 0-13.3%).ConclusionsThe long-term rate of mesh erosion following an abdominally placed synthetic graft is low.
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Project description:IntroductionSurgical site infections (SSIs) are among the most common complications after abdominal surgery and develop in approximately 20% of patients. These patients suffer a 12% increase in mortality, underlying the need for strategies reducing SSI. Perioperative antibiotic prophylaxis is paramount for SSI prevention in major abdominal surgery. Yet, intraoperative redosing criteria are subjective and whether patients benefit from it remains unclear.Methods and analysisThe REpeat versus SIngle ShoT Antibiotic prophylaxis in major Abdominal Surgery (RESISTAAS I) study is a single-centre, prospective, observational study investigating redosing of antibiotic prophylaxis in 300 patients undergoing major abdominal surgery. Adult patients scheduled for major abdominal surgery will be included. Current practice of redosing regarding number and time period will be recorded. Postoperative SSIs, nosocomial infections, clinically relevant infection-associated bacteria, postoperative antibiotic treatment, in addition to other clinical, pharmacological and economical outcomes will be evaluated. Differences between groups will be analysed with analysis of covariance.Ethics and disseminationRESISTAAS I will be conducted in accordance with the Declaration of Helsinki and internal, national and international standards of GCP. The Medical Ethics Review Board of Heidelberg University has approved the study prior to initiation (S-404/2021). The study has been registered on 7 February 2022 at German Clinical Trials Register, with identifier DRKS00027892. We plan to disseminate the results of the study in a peer-reviewed journal.Trial registrationGerman Clinical Trials Register (DRKS): DRKS00027892.
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Project description:PurposeOral problems in a group of oncological patients undergoing chemotherapy (CT) for solid tumors have been examined. Incidence and severity of patients' self-reported oral problems have been evaluated along their interaction with age, gender, tumor diagnosis and stage, presence of mestastasis, CT agent type, and number of CT cycle. We also analyzed the presence of paraesthesia and anaesthesia and their predisposing factors associated with clinical and treatment-related variables.MethodsPatients were asked to fill in a questionnaire to evaluate the onset and the intensity of oral and perioral pain, oral mucositis, salivary gland hypofunction, dysgeusia, dysphagia, dysphonia, and sensitivity neuropathy (paraesthesia or dysaesthesia) since the last CT infusion. We also investigated which types of medications have possibly been used and who recommended it, as well as patients' degree of awareness about the possibility of oral problems arising during CT.ResultsWe recruited 194 patients and obtained 491 questionnaires. We found that a metastatic disease was a risk factor for OM (OR 2.02, p = 0.026) and salivary gland hypofunction (OR 1.66, p = 0.042) and that platinum agents, compared to mitotic inhibitors, increased the risk of developing salivary gland hypofunction (OR 2.16, p = 0.013), dysphagia (OR 3.26, p = 0.001), and anaesthesia (OR 5.16, p = 0.041). Young age was a slight protective factor for most symptoms. The 80% of enrolled patients were informed by the oncologist about possible oral problems arising during CT.ConclusionsOur study highlighted the importance of collecting observational data from the patients' perspective on oral problems arising during the routine oncology practice, across a range of solid tumors and CT regimens. The relevance of these findings focused on the key role of the multidisciplinary team in advising the patients on the possible occurrence of oral problems, also by recommending their management.
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Project description:BackgroundHernia repairs account for millions of general surgical procedures performed each year worldwide, with a notable shift to outpatient settings over the last decades. As technical possibilities such as smartphones, tablets, and different kinds of probes are becoming more and more available, such systems have been evaluated for applications in various clinical settings. However, there have been few studies conducted in the surgical field, especially in general surgery.ObjectiveWe aimed to assess the feasibility of a tablet-based follow up to monitor activity levels after repair of abdominal wall hernias and to evaluate a possible reduction of adverse events by their earlier recognition.MethodsPatients scheduled for elective surgical repair of minor abdominal wall hernias (eg, inguinal, umbilical, or trocar hernias) were equipped with a telemonitoring system, including a tablet, pulse oximeter, and actimeter, for a monitoring phase of 7 days before and 30 days after surgery. Descriptive statistical analyses were performed.ResultsWe enrolled 16 patients with a mean overall age of 48.75 (SD 16.27) years. Preoperative activity levels were reached on postoperative day 12 with a median of 2242 (IQR 0-4578) steps after plunging on the day of surgery. The median proportion of available activity measurements over the entire study period of 38 days was 69% (IQR 56%-81%). We observed a gradual decrease in the proportion of available data for all parameters during the postoperative course. Six out of ten patients (60%) regained preoperative activity levels within 3 weeks after surgery. Overall, patients rated the usability of the system as relatively easy.ConclusionsTablet-based follow up is feasible after surgical repair of minor abdominal wall hernias, with good adherence rates during the first couple of weeks after surgery. Thus, such a system could be a useful tool to supplement or even replace traditional outpatient follow up in selected general surgical patients.
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Project description:Haemophilia is a rare genetic disorder, that results from various degrees of deficiency of coagulation factor VIII (haemophilia A), or factor IX (haemophilia B), with an X-linked transmission. The patients affected are in the majority of cases males (who inherit the affected X-chromosome from the maternal side), with rare cases of females with haemophilia (FVIII or FIX < 40 IU/dL), situations in which both X-chromosomes are affected, or one is affected, and the other one is inactive (known as carrier). The hypocoagulable state due to the deficiency of clotting factors, manifests as an excessive, recurrent tendency to bleeding, which positively correlates with plasmatic levels. Severe haemophilia results in hemarthrosis, although recent data have shown that moderate or even mild disease can lead to joint bleeding. Recurrent episodes of haemorrhages, usually affecting large joints such as knees, elbows, or ankles, lead to joint remodelling and subsequent haemophilic arthropathy, which may require arthroplasty as a last therapeutic option. Orthopaedic patients have the highest risk among all for deep vein thrombosis (DVT) and venous thromboembolism (VTE) with morbid and potentially fatal consequences. While for the rest of the population thromboprophylaxis in orthopaedic surgery is efficient, relatively safe, and widely used, for patients with haemophilia who are considered to have a low thromboembolic risk, there is great controversy. The great heterogeneity of this particular population, and the lack of clinical trials, with only case reports or observational studies, makes thromboprophylaxis in major orthopaedic surgery a tool to be used by every clinician based on experience and case particularities. This review aims to briefly summarise the latest clinical data and to offer an insight into the current recommendations that readers would find useful in daily practice.
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Project description:Major laparoscopic pelvic surgery requires steep Trendelenburg position with pneumoperitoneum for a long time. We investigated the effect of Trendelenburg position with pneumoperitoneum on diaphragmatic excursion and lung compliance during major laparoscopic pelvic surgery using M-mode sonography. Twenty patients undergoing elective pelviscopic radical hysterectomy were included in this study. Diaphragmatic excursion was measured at the following time points; after sedation, after intubation, 90 minutes after Trendelenburg position with pneumoperitoneum, and after operation with recovery of muscle relaxation. And lung compliance was measured using anesthetic machine under general anesthesia; after the intubation, 90 minutes after Trendelenburg position with pneumoperitoneum and after operation with recovery of muscle relaxation. In order to detect postoperative pulmonary complication, postoperative chest radiography was checked. Static lung compliance, dynamic lung compliance and diaphragmatic excursion were decreased during operation (P < 0.001, respectively). At the end of the operation with recovery of muscle relaxation, reduced diaphragmatic movement was not recovered as its excursion after sedation (P < 0.001). In conclusion, lung compliance was decreased following transiently decreased diaphragmatic excursion during major laparoscopic pelvic surgery.
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Project description:BACKGROUND:Major abdominal surgery (MAS) is associated with increased morbidity and mortality. The main objective of our study was to evaluate the predictive value of heart-rate variability (HRV) concerning development of postoperative complications in patients undergoing MAS. The secondary objectives were to identify the relationship of HRV and use of vasoactive drugs during anesthesia, intensive care unit length of stay (ICU-LOS), and hospital length of stay (H-LOS). PATIENTS AND METHODS:Sixty-five patients scheduled for elective MAS were enrolled in a prospective, single-center, observational study. HRV was measured by spectral analysis (SA) preoperatively during orthostatic load. Patients were divided according to cardiac autonomic reactivity (CAR; n=23) and non-cardiac autonomic reactivity (NCAR; n=30). RESULTS:The final analysis included 53 patients. No significant difference was observed between the two groups regarding type of surgery, use of minimally invasive techniques or epidural catheter, duration of surgery and anesthesia, or the amount of fluid administered intraoperatively. The NCAR group had significantly greater intraoperative blood loss than the CAR group (541.7±541.9 mL vs 269.6±174.3 mL, p<0.05). In the NCAR group, vasoactive drugs were used during anesthesia more frequently (n=21 vs n=4; p<0.001), and more patients had at least one postoperative complication compared to the CAR group (n=19 vs n=4; p<0.01). Furthermore, the NCAR group had more serious complications (Clavien-Dindo ≥ Grade III n=6 vs n=0; p<0.05) and a greater number of complications than the CAR group (n=57 vs n=5; p<0.001). Significant differences were found for two specific subgroups of complications: hypotension requiring vasoactive drugs (NCAR: n=10 vs CAR: n=0; p<0.01) and ileus (NCAR: n=11 vs CAR: n=2; p<0.05). Moreover, significant differences were found in the ICU-LOS (NCAR: 5.7±3.5 days vs CAR: 2.6±0.7 days; p<0.0001) and H-LOS (NCAR: 12.2±5.6 days vs CAR: 7.2±1.7 days; p<0.0001). CONCLUSION:Preoperative HRV assessment during orthostatic load is objective and useful for identifying patients with low autonomic physiological reserves and high risk of poor post-operative course.
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Project description:BackgroundMetabolic status can be impacted by general anesthesia and surgery. However, the exact effects of general anesthesia and surgery on systemic metabolome remain unclear, which might contribute to postoperative outcomes.MethodsFive hundred patients who underwent abdominal surgery were included. General anesthesia was mainly maintained with sevoflurane. The end-tidal sevoflurane concentration (ETsevo) was adjusted to maintain BIS (Bispectral index) value between 40 and 60. The mean ETsevo from 20 min after endotracheal intubation to 2 h after the beginning of surgery was calculated for each patient. The patients were further divided into low ETsevo group (mean - SD) and high ETsevo group (mean + SD) to investigate the possible metabolic changes relevant to the amount of sevoflurane exposure.ResultsThe mean ETsevo of the 500 patients was 1.60% ± 0.34%. Patients with low ETsevo (n = 55) and high ETsevo (n = 59) were selected for metabolomic analysis (1.06% ± 0.13% vs. 2.17% ± 0.16%, P < 0.001). Sevoflurane and abdominal surgery disturbed the tricarboxylic acid cycle as identified by increased citrate and cis-aconitate levels and impacted glycometabolism as identified by increased sucrose and D-glucose levels in these 114 patients. Glutamate metabolism was also impacted by sevoflurane and abdominal surgery in all the patients. In the patients with high ETsevo, levels of L-glutamine, pyroglutamic acid, sphinganine and L-selenocysteine after sevoflurane anesthesia and abdominal surgery were significantly higher than those of the patients with low ETsevo, suggesting that these metabolic changes might be relevant to the amount of sevoflurane exposure.ConclusionsSevoflurane anesthesia and abdominal surgery can impact principal metabolic pathways in clinical patients including tricarboxylic acid cycle, glycometabolism and glutamate metabolism. This study may provide a resource data for future studies about metabolism relevant to general anaesthesia and surgeries.Trial registrationwww.chictr.org.cn . identifier: ChiCTR1800014327 .
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Project description:BackgroundThe drop in plasma albumin concentration following surgical trauma is well known, but the temporal pattern of the detailed mechanisms behind are less well described. The aim of this explorative study was to assess changes in albumin synthesis and transcapillary escape rate (TER) following major surgical trauma, at the time of peak elevations in two well-recognized markers of inflammation.MethodsThis was a clinical trial of radiolabeled human serum albumin for the study of TER and plasma volume. Ten patients were studied immediately preoperatively and on the 2nd postoperative day after major pancreatic surgery. Albumin synthesis rate was measured by the flooding dose technique employing incorporation of isotopically labelled phenylalanine.ResultsFractional synthesis rate of albumin increased from 11.7 (95% CI: 8.9, 14.5) to 15.0 (11.7, 18.4) %/day (p = 0.027), whereas the corresponding absolute synthesis rate was unchanged, 175 (138, 212) versus 150 (107, 192) mg/kg/day (p = 0.21). TER was unchanged, 4.9 (3.1, 6.8) %/hour versus 5.5 (3.9, 7.2) (p = 0.63). Plasma volume was unchanged but plasma albumin decreased from 33.5 (30.9, 36.2) to 22.1 (19.8, 24.3) g/L. (p<0.001).ConclusionTwo days after major abdominal surgery, at the time-point when two biomarkers of generalised inflammation were at their peak and the plasma albumin concentration had decreased by 33%, we were unable to show any difference in the absolute synthesis rate of albumin, TER and plasma volume as compared with values obtained immediately pre-operatively. This suggests that capillary leakage, if elevated postoperatively, had ceased at that time-point. The temporal relations between albumin kinetics, capillary leakage and generalised inflammation need to be further explored.Trial registrationclinicaltrialsregister.eu: EudraCT 2010-08529-21 ClinicalTrials.gov NCT01194492.
| S-EPMC4552033 | biostudies-literature
Project description:BackgroundPre-operative anaemia has been associated independently with worse outcomes after cardiac surgery in adults and is often caused by absolute or functional iron deficiency. Iron deficiency is a continuum ending with anaemia, and therefore it is plausible that pre-operative early or 'non-anaemic' iron deficiency may also be associated with worse outcomes in patients undergoing cardiac surgery.MethodsWe have designed a prospective, observational study to determine if there is an association between non-anaemic iron deficiency and worse outcomes after cardiac surgery in adults. Patients without anaemia undergoing elective cardiac surgery will be allocated to an iron-deficient and an iron-replete group based on standard pre-operative blood tests (ferritin, transferrin saturation and C-reactive protein). The primary outcome is days alive and at home on postoperative day 30. The key secondary outcomes are days alive and at home on postoperative day 90 and readmission to acute care. Other secondary outcomes include health-related quality of life questionnaires, quality of postoperative recovery, postoperative complications, changes in haemoglobin concentration, and requirement for allogeneic blood products. The planned study sample size is 240 patients per group, which has 83% power to detect a median difference of 1.25 days in the primary outcome. The study commenced in March 2018, and recently completed recruitment, with data audit and cleaning ongoing.DiscussionThis study will be conducted using a rigorous, prospective observational design; it will provide peak bodies and clinicians with high-quality evidence concerning the associations between non-anaemic iron deficiency and patient-centred outcomes after elective cardiac surgery. Our primary and key secondary outcomes are known to have great importance to clinicians and patients alike and align with the recommendations of the StEP-COMPAC group for outcomes in prospective peri-operative research. The definition used for iron deficiency accounts for both absolute and functional iron deficiency and make use of standard pre-operative blood tests to make this determination, easing the transition of results into clinical practice. The study will be conducted in two relatively high-volume centres in a single high-income country. This limits the generalisability of study results to similar centres.Trial registrationAustralian and New Zealand Clinical Trials Registry ( ACTRN12618000185268 ). Registered 5 February 2018.
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