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846 result(s) for "Preoperative Care - standards"
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Optimal fractionation of preoperative radiotherapy and timing to surgery for rectal cancer (Stockholm III): a multicentre, randomised, non-blinded, phase 3, non-inferiority trial
Radiotherapy reduces the risk of local recurrence in rectal cancer. However, the optimal radiotherapy fractionation and interval between radiotherapy and surgery is still under debate. We aimed to study recurrence in patients randomised between three different radiotherapy regimens with respect to fractionation and time to surgery. In this multicentre, randomised, non-blinded, phase 3, non-inferiority trial (Stockholm III), all patients with a biopsy-proven adenocarcinoma of the rectum, without signs of non-resectability or distant metastases, without severe cardiovascular comorbidity, and planned for an abdominal resection from 18 Swedish hospitals were eligible. Participants were randomly assigned with permuted blocks, stratified by participating centre, to receive either 5 × 5 Gy radiation dose with surgery within 1 week (short-course radiotherapy) or after 4–8 weeks (short-course radiotherapy with delay) or 25 × 2 Gy radiation dose with surgery after 4–8 weeks (long-course radiotherapy with delay). After a protocol amendment, randomisation could include all three treatments or just the two short-course radiotherapy treatments, per hospital preference. The primary endpoint was time to local recurrence calculated from the date of randomisation to the date of local recurrence. Comparisons between treatment groups were deemed non-inferior if the upper limit of a double-sided 90% CI for the hazard ratio (HR) did not exceed 1·7. Patients were analysed according to intention to treat for all endpoints. This study is registered with ClinicalTrials.gov, number NCT00904813. Between Oct 5, 1998, and Jan 31, 2013, 840 patients were recruited and randomised; 385 patients in the three-arm randomisation, of whom 129 patients were randomly assigned to short-course radiotherapy, 128 to short-course radiotherapy with delay, and 128 to long-course radiotherapy with delay, and 455 patients in the two-arm randomisation, of whom 228 were randomly assigned to short-course radiotherapy and 227 to short-course radiotherapy with delay. In patients with any local recurrence, median time from date of randomisation to local recurrence in the pooled short-course radiotherapy comparison was 33·4 months (range 18·2–62·2) in the short-course radiotherapy group and 19·3 months (8·5–39·5) in the short-course radiotherapy with delay group. Median time to local recurrence in the long-course radiotherapy with delay group was 33·3 months (range 17·8–114·3). Cumulative incidence of local recurrence in the whole trial was eight of 357 patients who received short-course radiotherapy, ten of 355 who received short-course radiotherapy with delay, and seven of 128 who received long-course radiotherapy (HR vs short-course radiotherapy: short-course radiotherapy with delay 1·44 [95% CI 0·41–5·11]; long-course radiotherapy with delay 2·24 [0·71–7·10]; p=0·48; both deemed non-inferior). Acute radiation-induced toxicity was recorded in one patient (<1%) of 357 after short-course radiotherapy, 23 (7%) of 355 after short-course radiotherapy with delay, and six (5%) of 128 patients after long-course radiotherapy with delay. Frequency of postoperative complications was similar between all arms when the three-arm randomisation was analysed (65 [50%] of 129 patients in the short-course radiotherapy group; 48 [38%] of 128 patients in the short-course radiotherapy with delay group; 50 [39%] of 128 patients in the long-course radiotherapy with delay group; odds ratio [OR] vs short-course radiotherapy: short-course radiotherapy with delay 0·59 [95% CI 0·36–0·97], long-course radiotherapy with delay 0·63 [0·38–1·04], p=0·075). However, in a pooled analysis of the two short-course radiotherapy regimens, the risk of postoperative complications was significantly lower after short-course radiotherapy with delay than after short-course radiotherapy (144 [53%] of 355 vs 188 [41%] of 357; OR 0·61 [95% CI 0·45–0·83] p=0·001). Delaying surgery after short-course radiotherapy gives similar oncological results compared with short-course radiotherapy with immediate surgery. Long-course radiotherapy with delay is similar to both short-course radiotherapy regimens, but prolongs the treatment time substantially. Although radiation-induced toxicity was seen after short-course radiotherapy with delay, postoperative complications were significantly reduced compared with short-course radiotherapy. Based on these findings, we suggest that short-course radiotherapy with delay to surgery is a useful alternative to conventional short-course radiotherapy with immediate surgery. Swedish Research Council, Swedish Cancer Society, Stockholm Cancer Society, and the Regional Agreement on Medical Training and Clinical Research in Stockholm.
The impact of preoperative vitamin administration on skeletal status following sleeve gastrectomy in young and middle-aged women: a randomized controlled trial
BackgroundThe appropriate strategies to minimize skeletal deterioration following bariatric surgeries are inconclusive. This randomized controlled trial evaluated the effect of preoperative vitamin supplementation on bone mineral density (BMD) and biochemical parameters in females post-sleeve gastrectomy (SG).MethodsParticipants were randomized to a 2-month preoperative treatment with a multivitamin and vitamin D 4000 IU/d (intervention arm) or 1200 IU/d (control arm). Preoperative and 12-month postoperative follow-up evaluations included anthropometrics, biochemical parameters, and dual energy X-ray absorptiometry (DEXA).ResultsSixty-two females (median age 29.7 years and median BMI 43.4 kg/m2) were recruited, 87% completed the 12-month follow-up. For the intervention and control arms, significant and similar reductions at 12-months post-surgery were observed in BMD of the hip (−6.8 ± 3.7% vs. −6.0 ± 3.6%; P = 0.646) and of the femoral neck (−7.1 ± 5.8% vs. −7.2 ± 5.5%; P = 0.973). For the intervention compared to the control arm, the 25 hydroxyvitamin D (25(OH)D) increment was greater after 2 months treatment, and vitamin D deficiency rates were lower at 3 and 6-months follow-up (P < 0.016). However, at 12-months postoperative, 25(OH)D values and vitamin D deficiency were comparable between the arms (P > 0.339). Predictors for BMD decline in the total hip were the percentage of excess weight-loss, age>50 years, and lower initial BMI (P ≤ 0.003).ConclusionsSG was associated with a significant decline in BMD of the hip and femoral neck in young and middle-aged women, and was unaffected by preoperative vitamin D supplementation. Females who are peri-menopausal or with greater postoperative weight-loss should be particularly followed for BMD decline.
Perceived facilitators and barriers among physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only in patients eligible for knee replacement: A qualitative interview study nested in the QUADX-1 trial
Clinical guidelines recommend non-surgical treatment before surgery is considered in patients eligible for knee replacement. Surgical treatment is provided by orthopedic surgeons and exercise therapy is provided by physical therapists. The aim of this study was to identify perceived facilitators and barriers-among orthopedic surgeons and physical therapists-towards coordinated non-surgical and surgical treatment of patients eligible for knee replacement using pre-operative home-based exercise therapy with one exercise. This qualitative study is embedded within the QUADX-1 randomized trial that investigates a model of coordinated non-surgical and surgical treatment for patients eligible for knee replacement. Physical therapists and orthopedic surgeons working with patients with knee osteoarthritis in their daily clinical work were interviewed (one focus group and four single interviews) to explore their perceived facilitators and barriers related to pre-operative home-based exercise therapy with one exercise-only in patients eligible for knee replacement. Interviews were analyzed using thematic analysis. From the thematic analysis three main themes emerged: 1) Physical therapists' dilemma with one home-based exercise, 2) Orthopedic surgeons' dilemma with exercise, and 3) Coordinated non-surgical and surgical care. We found that the pre-operative exercise intervention created ambivalence in the professional role of both the physical therapists and orthopedic surgeons. The physical therapists were skeptical towards over-simplified exercise therapy. The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement. The consequence of these barriers and ambivalence in the professional role is important to consider when planning implementation of the model of coordinated non-surgical and surgical treatment. ClinicalTrials.gov, ID: NCT02931058.
Effectiveness of a Group Game Intervention in Reducing Preoperative Anxiety Levels of Children and Parents: A Randomized Controlled Trial
Surgical experiences are often stressful for children and their parents. This study aimed to determine the effect of a group game intervention on the preoperative anxiety levels of 94 parent-child dyads who were awaiting elective minor surgery at a pediatric surgery clinic. The experimental group intervention included routine preoperative preparation and a group (ie, child, parent, and researcher) game. After the parent dressed the child for surgery, a research team member assessed the child's and parent's anxiety levels using the Facial Affective Scale and Visual Facial Anxiety Scale, respectively. Before the child was transferred to the OR, the research team member reassessed both anxiety levels. When compared to the control group, the results showed that children and parents involved in facilitated group play experienced significantly decreased anxiety levels (P < .001).
Effect of preoperative smoking intervention on postoperative complications: a randomised clinical trial
Smokers are at higher risk of cardiopulmonary and wound-related postoperative complications than nonsmokers. Our aim was to investigate the effect of preoperative smoking intervention on the frequency of postoperative complications in patients undergoing hip and knee replacement. We did a randomised trial in three hospitals in Denmark. 120 patients were randomly assigned 6–8 weeks before scheduled surgery to either the control (n=60) or smoking intervention (60) group. Smoking intervention was counselling and nicotine replacement therapy, and either smoking cessation or at least 50% smoking reduction. An assessor, who was masked to the intervention, registered the occurrence of cardiopulmonary, renal, neurological, or surgical complications and duration of hospital admittance. The main analysis was by intention to treat. Eight controls and four patients from the intervention group were excluded from the final analysis because their operations were either postponed or cancelled. Thus, 52 and 56 patients, respectively, were analysed for outcome. The overall complication rate was 18% in the smoking intervention group and 52% in controls (p=0·0003). The most significant effects of intervention were seen for wound-related complications (5%vs 31%, p=0·001), cardiovascular complications (0%vs 10%, p=0·08), and secondary surgery (4%vs 15%, p=0·07). The median length of stay was 11 days (range 7–55) in the intervention group and 13 days (8–65) in the control group. An effective smoking intervention programme 6–8 weeks before surgery reduces postoperative morbidity, and we recommend, on the basis of our results, this programme be adopted.
Quality assurance of the PREOPANC trial (2012-003181-40) for preoperative radiochemotherapy in pancreatic cancer
Background The Dutch Pancreatic Cancer Group initiated the national, multicentre, controlled PREOPANC trial, randomising between preoperative radiochemotherapy and direct explorative laparotomy for patients with (borderline) resectable pancreatic cancer. The aim of this dummy run is to evaluate compliance with the radiotherapy protocol of this trial, and the quality of delineation and radiation plans. Methods Eleven radiation oncology departments open for accrual of patients in the PREOPANC trial were provided with all necessary information of a selected ‘dummy’ patient. Each institute was asked to delineate the target volumes, including gross tumour volume, internal gross tumour volume (iGTV), internal clinical target volume, and planning target volume. The institutions were also asked to provide a radiation treatment plan in accordance with the PREOPANC trial protocol. Results The range of the iGTV was 19.3–77.2 cm 3 with a mean iGTV of 41.5 cm 3 (standard deviation 14.8 cm 3 ). Nine institutions made a treatment plan using an arc technique for treatment delivery, one an intensity modulated technique and one a 3-field conformal technique. All institutions reached the prescribed target coverage, without exceeding the organs at risk constraints. The institution with the 3‑field conformal technique was advised to use a more sophisticated technique (e. g. volumetric modulated arc therapy) to reduce the dose to the spinal cord. Conclusion All institutions showed acceptable deviations from the PREOPANC trial protocol and achieved an acceptable quality of delineation and radiation technique. All institutions were allowed to continue participation in the PREOPANC trial.
Effects of preoperative carbohydrate loading on glucose metabolism and gastric contents in patients undergoing moderate surgery: A randomized, controlled trial
Despite contrary evidence, the practice of overnight fasting before elective surgery maintains its place in tradition. However, prolonged starvation, by its catabolic action, may increase the detrimental effects of surgery. In this study, we evaluated the effects of preoperative carbohydrate loading on the gastric contents of patients and perioperative metabolism. Seventy patients scheduled for cholecystectomy or thyroidectomy randomly were assigned to the treatment or control group. Patients in the treatment group ( n = 34) received 800 mL of a carbohydrate-rich fluid on the evening before surgery and 400 mL of the same fluid 2 h preoperatively. Conversely, control patients ( n = 36) underwent overnight fasting. Plasma glucose and serum insulin levels were obtained across the perioperative period and during anesthesia induction. The volume and pH of preoperative residual gastric contents also were measured. Preoperative plasma glucose levels were found to remain significantly higher in patients who had received the carbohydrate-rich fluid. Serum insulin levels that were elevated initially in the study group returned to control levels by the time of anesthesia induction. There was no statistical difference between the two groups with respect to gastric residue contents or gastric fluid pH. The preoperative intake of carbohydrate-rich fluids does not appear to alter the amount or pH of gastric contents, suggesting that this is a safe procedure, in terms of aspiration risk. Furthermore, the intake of such fluid might prevent energy malnutrition.
A custom-made guide-wire positioning device for Hip Surface Replacement Arthroplasty: description and first results
Background Hip surface replacement arthroplasty (SRA) can be an alternative for total hip arthroplasty. The short and long-term outcome of hip surface replacement arthroplasty mainly relies on the optimal size and position of the femoral component. This can be defined before surgery with pre-operative templating. Reproducing the optimal, templated femoral implant position during surgery relies on guide wire positioning devices in combination with visual inspection and experience of the surgeon. Another method of transferring the templated position into surgery is by navigation or Computer Assisted Surgery (CAS). Though CAS is documented to increase accurate placement particularly in case of normal hip anatomy, it requires bulky equipment that is not readily available in each centre. Methods A custom made neck jig device is presented as well as the results of a pilot study. The device is produced based on data pre-operatively acquired with CT-scan. The position of the guide wire is chosen as the anatomical axis of the femoral neck. Adjustments to the design of the jig are made based on the orthopedic surgeon's recommendations for the drill direction. The SRA jig is designed as a slightly more-than-hemispherical cage to fit the anterior part of the femoral head. The cage is connected to an anterior neck support. Four knifes are attached on the central arch of the cage. A drill guide cylinder is attached to the cage, thus allowing guide wire positioning as pre-operatively planned. Custom made devices were tested in 5 patients scheduled for total hip arthroplasty. The orthopedic surgeons reported the practical aspects of the use of the neck-jig device. The retrieved femoral heads were analyzed to assess the achieved drill place in mm deviation from the predefined location and orientation compared to the predefined orientation. Results The orthopedic surgeons rated the passive stability, full contact with neck portion of the jig and knife contact with femoral head, positive. There were no guide failures. The jig unique position and the number of steps required to put the guide in place were rated 1, while the complexity to put the guide into place was rated 1-2. In all five cases the guide wire was accurately positioned. Maximum angular deviation was 2.9° and maximum distance between insertion points was 2.1 mm. Conclusions Pilot testing of a custom made jig for use during SRA indicated that the device was (1) successfully applied and user friendly and (2) allowed for accurate guide wire placement according to the preoperative plan.
Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures
Open fractures frequently result in serious complications for patients, including infections, wound healing problems, and failure of fracture healing, many of which necessitate subsequent operations. One of the most important steps in the initial management of open fractures is a thorough wound irrigation and debridement to remove any contaminants. There is, however, currently no consensus regarding the optimal approach to irrigating open fracture wounds during the initial operative procedure. The selection of both the type of irrigating fluid and the pressure of fluid delivery remain controversial. The primary objective of this study is to investigate the effects of irrigation solutions (soap vs. normal saline) and pressure (low vs. high; gravity flow vs. high; low vs. gravity flow) on re-operation within one year among patients with open fractures. The FLOW study is a multi-center, randomized controlled trial using a 2 x 3 factorial design. Surgeons at clinical sites in North America, Europe, Australia, and Asia will recruit 2 280 patients who will be centrally randomized into one of the 6 treatment arms (soap + low pressure; soap + gravity flow pressure; soap + high pressure; saline + low pressure; saline + gravity flow pressure; saline + high pressure). The primary outcome of the study is re-operation to promote wound or bone healing, or to treat an infection. This composite endpoint of re-operation includes a narrow spectrum of patient-important procedures: irrigation and debridement for infected wound, revision and closure for wound dehiscence, wound coverage procedures for infected or necrotic wound, bone grafts or implant exchange procedures for established nonunion in patients with postoperative fracture gaps less than 1 cm, intramedullary nail dynamizations in the operating room, and fasciotomies for compartment syndrome. Patients, outcome adjudicators, and data analysts will be blinded. We will compare rates of re-operation at 12 months across soap vs. saline, low pressure vs. high pressure, gravity flow pressure vs. high pressure, and low pressure vs. gravity flow pressure. We will measure function and quality of life with the Short Form-12 (SF-12) and the EuroQol-5 Dimensions (EQ-5D) at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months after initial surgical management, and measure patients' illness beliefs with the Somatic Pre-Occupation and Coping (SPOC) questionnaire at 1 and 6 weeks. We will also compare non-operatively managed infections, wound healing, and fracture healing problems at 12 months after initial surgery. This study represents a major international effort to identify a simple and easily applicable strategy for emergency wound management. The importance of the question and the potential to identify a low cost treatment strategy argues strongly for global participation, especially in low and middle income countries such as India and China where disability from traumatic injuries is substantial. This trial is registered at ClinicalTrials.gov (NCT00788398).
Evaluating the accuracy of ChatGPT-4 in predicting ASA scores: A prospective multicentric study ChatGPT-4 in ASA score prediction
This study investigates the potential of ChatGPT-4, developed by OpenAI, in enhancing medical decision-making processes, particularly in preoperative assessments using the American Society of Anesthesiologists (ASA) scoring system. The ASA score, a critical tool in evaluating patients' health status and anesthesia risks before surgery, categorizes patients from I to VI based on their overall health and risk factors. Despite its widespread use, determining accurate ASA scores remains a subjective process that may benefit from AI-supported assessments. This research aims to evaluate ChatGPT-4's capability to predict ASA scores accurately compared to expert anesthesiologists' assessments. In this prospective multicentric study, ethical board approval was obtained, and the study was registered with clinicaltrials.gov (NCT06321445). We included 2851 patients from anesthesiology outpatient clinics, spanning neonates to all age groups and genders, with ASA scores between I-IV. Exclusion criteria were set for ASA V and VI scores, emergency operations, and insufficient information for ASA score determination. Data on patients' demographics, health conditions, and ASA scores by anesthesiologists were collected and anonymized. ChatGPT-4 was then tasked with assigning ASA scores based on the standardized patient data. Our results indicate a high level of concordance between ChatGPT-4 predictions and anesthesiologists' evaluations, with Cohen's kappa analysis showing a kappa value of 0.858 (p = 0.000). While the model demonstrated over 90% accuracy in predicting ASA scores I to III, it showed a notable variance in ASA IV scores, suggesting a potential limitation in assessing patients with more complex health conditions. The findings suggest that ChatGPT-4 can significantly contribute to the medical field by supporting anesthesiologists in preoperative assessments. This study not only demonstrates ChatGPT-4's efficacy in medical data analysis and decision-making but also opens new avenues for AI applications in healthcare, particularly in enhancing patient safety and optimizing surgical outcomes. Further research is needed to refine AI models for complex case assessments and integrate them seamlessly into clinical workflows. •Introduced ChatGPT-4's capability in accurately predicting American Society of Anesthesiologists (ASA) scores, marking a significant advancement in preoperative patient assessments.•Conducted a prospective multicentric study involving 2851 patients, ensuring a comprehensive evaluation across diverse patient demographics.•Demonstrated high concordance between ChatGPT-4 predictions and expert anesthesiologists’ evaluations, with a notable kappa value of 0.858.•Identified limitations and areas for improvement in AI’s assessment of complex health conditions, particularly in patients with ASA IV scores.•Highlighted the potential of integrating artificial intelligence in enhancing the objectivity and efficiency of preoperative assessments, contributing to safer anesthesia practices and optimized surgical outcomes.