Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial.

BACKGROUND: The management of pain after shoulder surgery typically includes the use of cryotherapy and the prescription of opioid analgesics. Much focus has been placed lately on the opioid epidemic, which in part is fueled by excessive prescription of opioid medication. Previous studies have found a combination of cryotherapy and compression effective at reducing analgesic consumption and increasing recovery in patients undergoing knee and spine surgery; however, efficacy in patients undergoing shoulder surgery has not been evaluated. PURPOSE: To evaluate the effectiveness of a cryo-pneumatic compression device on postoperative shoulder pain, narcotic use, and quality of life when compared with standard care cryotherapy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: In total, 200 patients older than 18 years scheduled for unilateral shoulder surgery were enrolled. Patients were randomized to receive either postoperative cryo-pneumatic compression or standard care. The intervention group received a cryo-pneumatic device, while the standard care group received the treating surgeon's preferred method of postoperative care, including standard cryotherapy. Narcotic use was evaluated by the number of oral morphine milligram equivalents consumed during the postoperative period, as well as the time to cessation of narcotic use. Patient-reported outcome measures consisted of a numeric rating scale pain score, 36-item Short Form Survey, patient experience assessed using the net promoter score, and adverse events. Outcomes were evaluated at 2, 6, and 12 weeks postoperatively. RESULTS: Patients receiving cryo-pneumatic compression reported a significant decrease in opioid consumption when compared with standard care (oral morphine milligram equivalents median, 56.1 vs 112; P = .02468). A significant increase in self-reported function was seen in the cryo-pneumatic compression group at 2 weeks when compared with standard care (mean, 61.2 vs 54.2; P = .0412). CONCLUSION: In patients undergoing unilateral shoulder surgery, the use of cryotherapy with pneumatic compression, when compared with standard care, resulted in significantly decreased opioid consumption as well as increased function at 2 weeks. REGISTRATION: NCT04185064 (ClinicalTrials.gov identifier).

Perceptions in Orthopedic Surgery on the Use of Cannabis in Treating Pain: A Survey of Musculoskeletal Trauma Patients-Results From the Canadian POSIT Study.

OBJECTIVES: To evaluate the patient-reported expectations regarding cannabis for pain following musculoskeletal (MSK) trauma and patients' perceptions and attitudes regarding its use. DESIGN: A cross-sectional retrospective survey-based study. SETTING: Three orthopaedic clinics in Ontario (Level-1 trauma center, Level-2 trauma center, rehabilitation clinic). PATIENTS SELECTION CRITERIA: Adult patients presenting to the clinics from January 24, 2018, to March 7, 2018, with traumatic MSK injuries (fractures/dislocations and muscle/tendon/ligament injury) were administered an anonymous questionnaire on cannabis for MSK pain. OUTCOME MEASURES AND COMPARISONS: Primary outcome measure was the patients' perceived effect of cannabis on MSK pain, reported on a continuous pain scale (0%-100%, 0 being no pain, and 100 unbearable pain). Secondary outcomes included preferences, such as administration route, distribution method, timing, and barriers (lack of knowledge, concerns for side effects/addiction, moral/religious opposition, etc.) regarding cannabis use. RESULTS: In total, 440 patients were included in this study, 217 (49.3%) of whom were female and 222 (50.5%) were male, with a mean age of 45.6 years (range 18-92 years, standard deviations 15.6). Patients estimated that cannabis could treat 56.5% (95% CI 54.0%-59.0%) of their pain and replace 46.2% (95% CI 42.8%-49.6%) of their current analgesics. Nearly one-third (131/430, 30.5%) reported that they had used medical cannabis and more than one-quarter (123/430, 28.6%) used it in the previous year. Most felt that cannabis may be beneficial to treat pain (304/334, 91.0%) and reduce opioid use (293/331, 88.5%). Not considering using cannabis for their injury (132/350, 37.7%) was the most common reason for not discussing cannabis with physicians. Higher reported pain severity (ß = 0.2/point, 95% CI 0.1-0.3, P = 0.005) and previous medical cannabis use were associated with higher perceived pain reduction (ß = 11.1, 95% CI 5.4-16.8, P < 0.001). CONCLUSIONS: One in 3 orthopaedic trauma patients used medical cannabis. Patients considered cannabis could potentially be an effective option for managing traumatic MSK pain and believed that cannabis could reduce opioid usage following acute musculoskeletal trauma. These data will help inform clinicians discussing medical cannabis usage with orthopaedic trauma patients moving forward.

Psilocybin for clinical indications: A scoping review.

BACKGROUND: Psychedelic drugs have been of interest in medicine since the early 1950s. There has recently been a resurgence of interest in psychedelics. AIMS: The objective of this study is to determine the extent of the available literature on psilocybin for medical indications including the designs used, study characteristics, indications studied, doses, and authors' conclusions. We identify areas for further study where there are research gaps. METHODS: We conducted a systematic scoping review of clinical indications for psilocybin, encompassing psychiatric and medical conditions. We systematically searched Medline and Embase using keywords related to psilocybin. We reviewed titles and texts in duplicate using Covidence software. We extracted data individually in duplicate using Covidence software and a senior reviewer resolved all author conflicts. We analyzed data descriptively. RESULTS: We included 193 published and 80 ongoing studies. Thirty-seven percent of included studies were systematic reviews. Only 12% of included studies were randomized controlled trials. The median number of participants was 22 with a median of 18 participants who had taken psilocybin. Thirty-eight percent of studies reported at least one potential conflict of interest. The most common indication was depression (28%). Also commonly studied were substance use (14%), mental health in life-threatening illness (9%), headaches (6%), depression and anxiety (6%), obsessive-compulsive disorder (3%), and anxiety disorders (3%). CONCLUSIONS: Most studies involving the administration of psilocybin have small sample sizes and the most common focus has been psychiatric disorders. There is a need for high-quality randomized trials on psilocybin and to expand consideration to other promising indications, such as chronic pain.

Appropriateness and Quality of Composite Endpoint Use and Reporting in Spine Surgery: A Systematic Review.

BACKGROUND: A composite endpoint (CEP) is a measure comprising 2 or more separate component outcomes. The use of these constructs is increasing. We sought to conduct a systematic review on the usage, quality of reporting, and appropriate use of CEPs in spine surgery research. METHODS: A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Articles reporting randomized controlled trials of a spine surgery intervention using a CEP as a primary outcome were included. We assessed the quality of CEP reporting, appropriateness of CEP use, and correspondence between CEP treatment effect and component outcome treatment effect in the included trials. RESULTS: Of 2,321 initial titles, 43 citations were included for analysis, which reported on 20 unique trials. All trials reported the CEP construct well. In 85% of trials, the CEP design was driven by US Food and Drug Administration guidance. In the majority of trials, the reporting of CEP results did not adhere to published recommendations: 43% of tests that reported statistically significant results on component outcomes were not statistically significant when adjusted for multiple testing. 67% of trials did not meet appropriateness criteria for CEP use. In addition, CEP treatment effect tended to be 6% higher than the median treatment effect for component outcomes. CONCLUSION: Given that CEP analysis was not appropriate for the majority of spine surgery trials and the inherent challenges in the reporting and interpretation of CEP analysis, CEP use should not be mandated by regulatory bodies in spine surgery trials. LEVEL OF EVIDENCE: Level I. See Instructions for Authors for a complete description of levels of evidence.

Trends in using intraoperative parathyroid hormone monitoring during parathyroidectomy: Protocol and rationale for a cross-sectional survey study of North American surgeons.

Hyperparathyroidism is a common endocrine disorder that occurs secondary to abnormal parathyroid gland functioning. Depending on the type of hyperparathyroidism, surgical extirpation of hyperfunctioning parathyroid glands can be considered for disease cure. Intraoperative parathyroid hormone (IOPTH) monitoring improves outcomes in patients undergoing surgery for primary hyperparathyroidism, but studies are needed to characterize its institutional adoption and its role in surgery for secondary and tertiary hyperparathyroidism, as these entities can be difficult to cure. Hence, we will perform a cross-sectional survey study of surgeon rationale, operational details, and barriers associated with IOPTH monitoring adoption across North America. We will utilize a convenience sampling technique to distribute an online survey to head and neck surgeons and endocrine surgeons across North America. This survey will be distributed via email to three North American professional societies (i.e., Canadian Society for Otolaryngologists-Head and Neck Surgeons, American Head and Neck Society, and American Association of Endocrine Surgeons). The survey will consist of 30 multiple choice questions that are divided into three concepts: (1) participant demographics and training details, (2) details of surgical adjuncts during parathyroidectomy, and (3) barriers to adoption of IOPTH. Descriptive analyses and multiple logistic regression will be used to evaluate the impact of demographic, institutional, and training variables on the use of IOPTH monitoring in surgery for all types of hyperparathyroidism and barriers to IOPTH monitoring adoption. Ethics approval was obtained by the Hamilton Integrated Research Ethics Board (2024-17173-GRA). These findings will characterize surgeon and institutional practices with regards to IOPTH monitoring during parathyroid surgery and will inform future trials aimed to optimize the use of IOPTH monitoring in secondary and tertiary hyperparathyroidism.

Exploring the fragility of meta-analyses in ophthalmology: a systematic review.

OBJECTIVE: The fragility index (FI) of a meta-analysis evaluates the extent that the statistical significance can be changed by modifying the event status of individuals from included trials. Understanding the FI improves the interpretation of the results of meta-analyses and can help to inform changes to clinical practice. This review determined the fragility of ophthalmology-related meta-analyses. METHODS: Meta-analyses of randomized controlled trials with binary outcomes published in a journal classified as 'Ophthalmology' according to the Journal Citation Report or an Ophthalmology-related Cochrane Review were included. An iterative process determined the FI of each meta-analysis. Multivariable linear regression modeling evaluated the relationship between the FI and potential predictive factors in statistically significant and non-significant meta-analyses. RESULTS: 175 meta-analyses were included. The median FI was 6 (Q1-Q3: 3-12). This meant that moving 6 outcomes from one group to another would reverse the study's findings. The FI was 1 for 18 (10.2%) of the included meta-analyses and was ≤5 for 75 (42.4%) of the included meta-analyses. The number of events (p < 0.001) and the p-value (p < 0.001) were the best predictors of the FI in both significant and non-significant meta-analyses. CONCLUSION: The statistical significance of meta-analyses in ophthalmology often hinges on the outcome of a few patients. The number of events and the p-value are the most important factors in determining the fragility of the evidence. The FI is an easily interpretable measure that can supplement the reader's understanding of the strength of the evidence being presented. PROSPERO REGISTRATION: CRD42022377589.

Time from injury to hip-fracture surgery in low-income and middle-income regions: a secondary analysis of data from the International Orthopaedic Multicentre Study in Fracture Care (INORMUS).

BACKGROUND: Globally, fall-related injuries are a substantial problem, and 80% of fatal falls occur in low-income and middle-income countries. We aimed to measure time from injury to hip-fracture surgery in people aged 50 years or older living in low-income and middle-income regions, as well as to measure the proportion of patients with surgical stabilisation of their hip fracture within 72 h of admission to hospital and to identify risk factors associated with surgical delay. METHODS: For this secondary analysis, we analysed data collected from Africa, Latin America, China, India, and Asia (excluding China and India) for the International Orthopaedic Multicentre Study in Fracture Care (INORMUS) between March 29, 2014, and June 15, 2022. Patients from INORMUS were included in this analysis if they were aged 50 years or older and had an isolated, primary hip fracture sustained from a ground-level fall. Staff at participating hospitals identified patients with musculoskeletal injury and referred them for assessment of eligibility. We report time from injury to surgery as three distinct time periods: time from injury to hospital admission, time from admission to surgery, and a total time from injury to surgery. Date and time of injury were self-reported by patients at the time of study recruitment. If time to hospital admission after injury exceeded 24 h, patients reported the primary reason for delayed admission. Reasons for surgery, no surgery, and surgical delay were reported by the treating team. For patients undergoing surgery, multivariable regression analyses were used to identify risk factors for surgical delay. FINDINGS: 4486 adults aged 50 years or older with an isolated, primary hip fracture were enrolled in INORMUS from 55 hospitals in 24 countries. Countries were grouped into five regions: Africa (418 [9·3%] of 4486), Latin America (558 [12·4%]), China (1680 [37·4%]), India (1059 [23·6%]) and Asia (excluding China and India; 771 [17·2%]). Of 4486 patients, 3805 (84·8%) received surgery. The rate of surgery was similar in all regions except in Africa, where only 193 (46·3%) of 418 patients had surgery. Overall, 2791 (62·2%) of 4486 patients were admitted to hospital within 24 h of injury. However, 1019 (22·7%) of 4486 patients had delayed hospital admission of 72 h or more from injury. The two most common reasons for delayed admission of more than 24 h were transfer from another hospital (522 [36·2%] of 1441) and delayed care-seeking because patients thought the injury would heal on its own (480 [33·3%]). Once admitted to hospital, 1451 (38·1%) of 3805 patients who received surgery did so within 72 h (median 4·0 days [IQR 1·7-6·0]). Regional variation was seen in the proportion of patients receiving surgery within 72 h of hospital admission (92 [17·9%] of 514 in Latin America, 53 [27·5%] of 193 in Africa, 454 [30·9%] of 1471 in China, 318 [44·4%] of 716 in Asia [excluding China and India], and 534 [58·6%] of 911 in India). Of all 3805 patients who received operative treatment, 2353 (61·8%) waited 72 h or more from hospital admission. From time of injury, the proportion of patients who were surgically stabilised within 72 h was 889 (23·4%) of 3805 (50 [9·7%] of 517 in Latin America, 31 [16·1%] of 193 in Africa, 277 [18·8%] of 1471 in China, 189 [26·4%] of 716 in Asia [excluding China and India], and 342 [37·5%] of 911 in India). INTERPRETATION: Access to surgery within 72 h of hospital admission was poor, with factors that affected time to surgery varying by region. Data are necessary to understand existing pathways of hip-fracture care to inform the local development of quality-improvement initiatives. FUNDING: The National Health and Medical Research Council of Australia, the Canadian Institutes of Health Research, McMaster Surgical Associates, Hamilton Health Sciences, and the US National Institutes of Health.

Duodeno-ileal diversion with self-forming magnets in a sutureless neodymium anastomosis procedure (SNAP) for weight recidivism after sleeve gastrectomy: feasibility and 9-month results.

BACKGROUND: The sleeve gastrectomy (SG) has become the most common bariatric procedure worldwide. However, insufficient weight loss or weight recidivism is frequent, which may require effective and safe revisional procedures. OBJECTIVE: To determine the technical feasibility and safety of a minimally invasive, duodeno-ileal side-to-side anastomosis using a Sutureless Neodymium Anastomosis Procedure (SNAP) for patients with weight recidivism or inadequate weight loss following SG. METHODS: This is a prospective, single-arm, open-label pilot study that enrolled patients with obesity to assist in weight reduction following an SG performed > 12 months prior. For the SNAP, self-assembling magnets were deployed into the ileum (laparoscopically) and duodenum (per-oral endoscopy). Magnets were coupled under laparoscopic and fluoroscopic guidance to create a compression anastomosis. The primary endpoints were technical feasibility, weight loss, and rate of serious adverse events (SAEs). RESULTS: Successful duodeno-ileal diversions were created with SNAP in 27 participants (mean age: 50.6 ± 9.1, mean BMI: 38.1 ± 4.6 kg/m2) with no device-related serious adverse events. Upper endoscopy at 3 months confirmed patent, healthy anastomoses in all patients. At 9 months, patients (n = 24) experienced 11.9 ± 6.2%, 14.5 ± 10.8%, and 17.0 ± 13.9% TBWL at 3, 6, and 9 months, respectively. There were no device-related SAEs. CONCLUSION: The SNAP is technically feasible and relatively safe, with all patients presenting widely patent anastomosis at 3 months. Patients experienced a progressive, clinically meaningful weight loss. Further studies are needed to confirm our findings.

Myocardial Injury in Patients with Hip Fracture: A HIP ATTACK Randomized Trial Substudy.

BACKGROUND: Myocardial injury after a hip fracture is common and has a poor prognosis. Patients with a hip fracture and myocardial injury may benefit from accelerated surgery to remove the physiological stress associated with the hip fracture. This study aimed to determine if accelerated surgery is superior to standard care in terms of the 90-day risk of death in patients with a hip fracture who presented with an elevated cardiac biomarker/enzyme measurement at hospital arrival. METHODS: The HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) trial was a randomized controlled trial designed to determine whether accelerated surgery for hip fracture was superior to standard care in reducing death or major complications. This substudy is a post-hoc analysis of 1392 patients (from the original study of 2970 patients) who had a cardiac biomarker/enzyme measurement (>99.9% had a troponin measurement and thus "troponin" is the term used throughout the paper) at hospital arrival. The primary outcome was all-cause mortality. The secondary composite outcome included all-cause mortality and non-fatal myocardial infarction, stroke, and congestive heart failure 90 days after randomization. RESULTS: Three hundred and twenty-two (23%) of the 1392 patients had troponin elevation at hospital arrival. Among the patients with troponin elevation, the median time from hip fracture diagnosis to surgery was 6 hours (interquartile range [IQR] = 5 to 13) in the accelerated surgery group and 29 hours (IQR = 19 to 52) in the standard care group. Patients with troponin elevation had a lower risk of mortality with accelerated surgery compared with standard care (17 [10%] of 163 versus 36 [23%] of 159; hazard ratio [HR] = 0.43 [95% confidence interval (CI) = 0.24 to 0.77]) and a lower risk of the secondary composite outcome (23 [14%] of 163 versus 47 [30%] of 159; HR = 0.43 [95% CI = 0.26 to 0.72]). CONCLUSIONS: One in 5 patients with a hip fracture presented with myocardial injury. Accelerated surgery resulted in a lower mortality risk than standard care for these patients; however, these findings need to be confirmed. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

A prospective cohort study of chronic postsurgical pain after ambulatory surgeries.

OBJECTIVE: The incidence and factors associated with chronic postsurgical pain (CPSP) after ambulatory surgeries have not been well studied. Our primary objective was to determine the incidence of CPSP and secondary objectives included assessment of intensity of CPSP, incidence of moderate-to-severe CPSP, and exploration of factors associated with CPSP. METHODS: This is a prospective cohort study of ambulatory surgery patients having procedures with a potential to cause moderate-to-severe postoperative pain. All patients had participated in a randomized controlled trial (RCT) showing no difference in achieving satisfactory analgesia in a recovery unit with either morphine or hydromorphone. CPSP was defined as chronic pain that developed or increased in intensity after the surgical procedure and is localized to the surgical field or within the innervation territory of a nerve in the surgical field, and has persisted for 3 months post-surgery, with the exclusion of other causes of pain. Incidences of CPSP were reported as rate (%) with 95% CI, and intensity using a 0-10 numerical rating scale (95% CI). We used logistic regression to explore factors associated with CPSP adjusting for baseline catastrophizing and depression. RESULTS: Among 402 RCT patients, 208 provided data for the 3-month outcome. Incidence of CPSP was 18.8% (39/208), 95% CI = 13.7%-24.7% and 78% (28/39) of them had moderate-to-severe CPSP. Average CPSP intensity was 5.5, 95% CI = 4.7-6.4. Every unit increase in pain over the first 24 h was significantly associated with increased odds of moderate-to-severe CPSP at 3 months; odds ratio = 1.28, 95% CI = 1.04-1.58. CONCLUSIONS: Nearly one in five patients develop CPSP after ambulatory surgeries with the majority of them having moderate-to-severe pain. Considering that acute pain after discharge is associated with CPSP and that there are no formal care pathways to address this need, studies need to focus on evaluating feasible strategies to provide continuing care.

PReoperative very low-Energy diets for obese PAtients undergoing non-bariatric surgery Randomized Evaluation (PREPARE): a protocol for a pilot randomized controlled trial.

BACKGROUND: Patients with obesity presenting in need of surgical intervention are at 2-to-sixfold higher risk of prolonged hospitalization, infectious morbidity, venous thromboembolism, and more. To mitigate some of these concerns, prescribed preoperative weight loss via very low-energy diets (VLEDs) has become a standard of care for patients with obesity undergoing bariatric surgery. While VLEDs have become standard prior to bariatric surgery, their application in other surgical settings remains limited. A large, definitive trial is required to resolve the uncertainty surrounding their use in these patients. Prior to a definitive trial to compare the efficacy of VLEDs in patients with obesity undergoing major non-bariatric surgery, we require a pilot trial. We argue a pilot trial will provide the following critical feasibility insights: (1) assessment of recruitment ability, (2) evaluation of adherence to VLED regimens, and (3) assessment of our ability follow patients completely. METHODS: The proposed trial will be a multi-center, surgeon, outcome assessor, and data-analyst blinded, parallel pilot randomized controlled trial (RCT). Patients older than 18 years of age with a body mass index (BMI) of greater than 30 kg/m2 undergoing major elective non-bariatric surgery will be eligible for inclusion. Consecutive patients will be allocated 1:1 according to a computer-generated randomization schedule. Randomization will be stratified by center and will employ randomly permutated blocks. All patients in the intervention group will receive standard patient counseling on weight loss and an active VLED protocol. The preoperative VLED protocol will utilize commercially available weight loss products for three weeks preoperatively. The primary outcomes (randomization percentage, recruitment rate, intervention adherence, follow-up completion, network development) will assess feasibility. Descriptive statistics will be used to characterize the study sample. DISCUSSION: The PREPARE pilot RCT will aim to provide feasibility and safety data that will allow for the successful completion of the definitive PREPARE trial that has the potential to provide practice changing data pertaining to the regular use of VLEDs as a means of pre-habilitation for patients with obesity undergoing major non-bariatric surgery. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov (reference #NCT05918471) on June 23, 2023.

Adaptive clinical trials in surgery: A scoping review of methodological and reporting quality.

IMPORTANCE: Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical. OBJECTIVE: Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials. EVIDENCE REVIEW: We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods. FINDINGS: Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment. CONCLUSION AND RELEVANCE: Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

PREscribing preoperative weight loss prior to major non-bariatric abdominal surgery for patients with Elevated weight: Patient and Provider Survey Protocols (PREPARE surveys).

BACKGROUND: Preoperative very low energy diet (VLED) interventions are used routinely in patients undergoing bariatric surgery, a surgical subspecialty that deals almost exclusively with patients with obesity. Yet, their use and study has been limited in non-bariatric abdominal surgery. To investigate the use of VLEDs in non-bariatric surgery, we plan on conducting a randomized controlled trial (RCT). Prior to proceeding, however, we have designed two surveys as important pre-emptive studies aimed at elucidating patient and provider perspectives regarding these interventions. METHODS: The patient survey is a cross-sectional, single-center survey aimed at assessing the safety, adherence, barriers to adherence, and willingness to participate in preoperative optimization protocols with VLEDs prior to undergoing elective non-bariatric intra-abdominal surgery (S1 File). The population of interest is all adult patients with obesity undergoing elective non-bariatric intra-abdominal surgery at St. Joseph's Healthcare Hamilton who were prescribed a course of preoperative VLED. The primary outcomes will be safety and adherence. The target sample size is 35 survey responses. The provider survey is a cross-sectional national survey of practicing surgeons in Canada who perform major non-bariatric abdominal surgery aimed assessing the willingness and ability to prescribe preoperative weight loss interventions amongst practicing Canadian surgeons who perform major non-bariatric abdominal surgery (S2 File). The population of interest is independent practicing surgeons in Canada who perform major non-bariatric abdominal surgery. The primary outcome will be willingness to prescribe preoperative VLED to patients with obesity undergoing major non-bariatric abdominal surgery for both benign and malignant indications. The target sample size is 61 survey responses. Descriptive statistics will be used to characterize the sample populations. To determine variables associated with primary outcomes in the surveys, regression analyses will be performed. DISCUSSION: These survey data will ultimately inform the design of an RCT evaluating the efficacy of preoperative VLEDs for patients with obesity undergoing major abdominal surgery.

Technical Variations and Considerations around OAGB in IFSO-APC and IFSO-MENAC Chapters, an Expert Survey.

OBJECTIVE: This study aimed to evaluate the technical variations of one-anastomosis gastric bypass (OAGB) among IFSO-APC and MENAC experts. BACKGROUND: The multitude of technical variations and patient selection challenges among metabolic and bariatric surgeons worldwide necessitates a heightened awareness of these issues. Understanding different perspectives and viewpoints can empower surgeons performing OAGB to adapt their techniques, leading to improved outcomes and reduced complications. METHODS: The scientific team of IFSO-APC, consisting of skilled bariatric and metabolic surgeons specializing in OAGB, conducted a confidential online survey. The survey aimed to assess technical variations and considerations related to OAGB within the IFSO-APC and IFSO-MENAC chapters. A total of 85 OAGB experts participated in the survey, providing their responses through a 35-question online format. The survey took place from January 1, 2024, to February 15, 2024. RESULTS: Most experts do not perform OAGB for children and adolescents younger than 18 years. Most experts create the gastric pouch over a 36-40-F bougie and prefer to create a gastrojejunostomy, at the posterior wall of the gastric pouch. An anti-reflux suture during OAGB is performed in all patients by 51.8% of experts. Most experts set a common limb length of > 4 m in revisional and conversional OAGBs to prevent nutritional complications. CONCLUSION: The ongoing debate among metabolic and bariatric surgeons regarding the technical variations and patient selection in OAGB remains a significant point of discussion. This survey demonstrated the variations in technical aspects and patient selection for OAGB among MBS surgeons in the IFSO-APC and IFSO-MENAC chapters. Standardizing the OAGB technique is crucial to ensure optimal safety and efficacy in this procedure.

Investigation of divergent thinking among surgeons and surgeon trainees in Canada (IDEAS): a mixed-methods study.

OBJECTIVE: To assess the creative potential of surgeons and surgeon trainees, as measured by divergent thinking. The secondary objectives were to identify factors associated with divergent thinking, assess confidence in creative problem-solving and the perceived effect of surgical training on creative potential, and explore the value of creativity in surgery. DESIGN: We used a mixed-methods design, conducting a survey of divergent thinking ability using a validated questionnaire followed by two semi-structured interviews with top-scoring participants. PARTICIPANTS & SETTING: Surgeons and surgeon trainees in the Department of Surgery at McMaster University. OUTCOMES: The primary outcome was divergent thinking, assessed with the Abbreviated Torrance Test for Adults. Participants also self-assessed their confidence in creative problem-solving and the effect of surgical training on their creative potential. We performed descriptive analyses and multivariable linear regression to identify factors associated with divergent thinking. We conducted a thematic analysis of the interview responses. RESULTS: 82 surgeons and surgeon trainees were surveyed; 43 were junior trainees and 28 were senior trainees. General surgery, orthopaedic surgery and plastic surgery represented 71.9% of the participants. The median participant age was 28 years (range 24-73), 51.2% of whom were female. Participants demonstrated levels of divergent thinking that were higher but not meaningfully different from the adult norm (62.39 (95% CI 61.25, 63.53), p<0.001). While participants scored significantly higher than the average adult on fluency (the ability to produce quantities of ideas) and flexibility (the ability to process information in different ways) (p<0.001 for both), they scored below average on originality (the ability to produce uncommon, new or unique ideas) (p<0.001). Regression analysis identified higher divergent thinking scores among females (estimated ß=-3.58 (95% CI -6.25 to -0.90), p=0.010). CONCLUSIONS: The divergent thinking ability among surgeons and surgeon trainees was not meaningfully different from the adult normative score; however, their ability to generate original ideas was below average.

Arthroscopic stabilization surgery for first-time anterior shoulder dislocations: a systematic review and meta-analysis.

BACKGROUND: The optimal management of first-time anterior shoulder dislocations (FTASDs) remains controversial. Therefore, the purpose of this study was to assess the efficacy of arthroscopic stabilization surgery for FTASDs through a systematic review and meta-analysis of existing literature. METHODS: MEDLINE, Embase, and Web of Science were searched from inception to December 18, 2022, for single-arm or comparative studies assessing FTASDs managed with arthroscopic stabilization surgery following first-time dislocation. Eligible comparative studies included studies assessing outcomes following immobilization for an FTASD, or arthroscopic stabilization following recurrent dislocations. Eligible levels of evidence were I to IV. Primary outcomes included rates of shoulder redislocations, cumulative shoulder instability, and subsequent shoulder stabilization surgery. RESULTS: Thirty-four studies with 2222 shoulder dislocations were included. Of these, 5 studies (n = 408 shoulders) were randomized trials comparing immobilization to arthroscopic Bankart repair (ABR) after a first dislocation. Another 16 studies were nonrandomized comparative studies assessing arthroscopic Bankart repair following first-time dislocation (ABR-F) to either immobilization (studies = 8, n = 399 shoulders) or arthroscopic Bankart repair following recurrent dislocations (ABR-R) (studies = 8, n = 943 shoulder). Mean follow-up was 59.4 ± 39.2 months across all studies. Cumulative loss to follow-up was 4.7% (range, 0%-32.7%). A composite rate of pooled redislocation, cumulative instability, and reoperations across ABR-F studies was 6.8%, 11.2%, and 6.1%, respectively. Meta-analysis found statistically significant reductions in rates of redislocation (odds ratio [OR] 0.09, 95% confidence interval [CI] 0.04-0.3, P < .001), cumulative instability (OR 0.05, 95% CI 0.03-0.08, P < .001), and subsequent surgery (OR 0.08, 95% CI 0.04-0.15, P < .001) when comparing ABR-F to immobilization. Rates of cumulative instability (OR 0.32, 95% CI 0.22-0.47, P < .001) and subsequent surgery rates (OR 0.27, 95% CI 0.09-0.76, P = .01) were significantly reduced with ABR-F relative to ABR-R, with point estimate of effect favoring ABR-F for shoulder redislocation rates (OR 0.59, 95% CI 0.19-1.83, P = .36). Return to sport rates to preoperative levels or higher were 3.87 times higher following ABR-F compared to immobilization (95% CI 1.57-9.52, P < .001), with limited ABR-R studies reporting this outcome. The median fragility index of the 5 included randomized controlled trials (RCTs) was 2, meaning reversing only 2 outcome events rendered the trials' findings no longer statistically significant. CONCLUSION: Arthroscopic stabilization surgery for FTASDs leads to lower rates of redislocations, cumulative instability, and subsequent stabilization surgery relative to immobilization or arthroscopic stabilization surgery following recurrence. Although a limited number of RCTs have been published on the subject matter to date, the strength of their conclusions is limited by a small sample size and statistically fragile results.