Delayed Versus Early Laparoscopic Appendectomy for Adult Patients With Acute Appendicitis: A Randomized Controlled Trial.

OBJECTIVE: To assess whether delaying appendectomy until the following morning is non-inferior to immediate surgery in those with acute appendicitis presenting at night. BACKGROUND: Despite a lack of supporting evidence, those with acute appendicitis who present at night frequently have surgery delayed until the after morning. METHODS: The delay trial is a noninferiority randomized controlled trial conducted between 2018 and 22 at 2 tertiary care hospitals in Canada. Adults with imaging confirmed acute appendicitis who presented at night (8:00 pm -4:00 am ). Delaying surgery until after 6:00 am was compared with immediate surgery. The primary outcome was 30-day postoperative complications. An a prior noninferiority margin of 15% was deemed clinically relevant. RESULTS: One hundred twenty-seven of the planned 140 patients were enrolled in the Delayed Versus Early Laparoscopic Appendectomy (DELAY) trial (59 in the delayed group and 68 in the immediate group). The two groups were similar at baseline. The mean time between the decision to operate and surgery was longer in the delayed group (11.0 vs 4.4 hours, P < 0.0001). The primary outcome occurred in 6/59 (10.2%) of those in the delayed group versus 15/67 (22.4%) of those in the immediate group ( P = 0.07). The difference between groups met the a priori noninferiority criteria of +15% (risk difference -12.2%, 95% CI: -24.4% to +0.4%, test of noninferiority P < 0.0001). CONCLUSIONS: The DELAY study is the first trial to assess delaying appendectomy in those with acute appendicitis. We demonstrate the noninferiority of delaying surgery until the after morning.

Impact of COVID-19 Pandemic on Readmission Rates Following Colorectal Surgery: A Retrospective Cohort Study.

BACKGROUND: The COVID-19 pandemic placed increased pressure to discharge patients early; this could have resulted in rushed discharges requiring patients to return to hospital. The impact of the pandemic on readmission after colorectal surgery is unknown. METHODS: The National Surgical Quality Improvement Program (ACS-NSQIP) database was used to compare patients undergoing elective colorectal surgery in 2019 and 2020, prior to and during the COVID-19 pandemic. Multivariable logistic regression was used to examine variables associated with readmission. Propensity score matching was then used to compare patients in the pre-pandemic and pandemic cohorts. RESULTS: A total of 72,874 colorectal cases were included. There were 17.7% less cases in 2020. Rate of readmission was similar in both groups (9.6% vs. 9.4%). There were fewer patients discharged to a facility such as nursing facility or rehabilitation center in 2020, with more patients discharged home. Year was not associated with readmission on multivariable analysis. In the matched cohort, readmission rates did not differ (9.7% vs. 9.3% p = 0.129) nor did mortality (0.8% vs. 0.8% p = 0.686). CONCLUSIONS: No difference in readmission rates before or during the COVID-19 pandemic was observed; suggesting increased pressure to keep patients out of hospital in the COVID-19 pandemic did not result in patients being rushed home requiring repeat admission. More patients were discharged home with fewer to rehabilitation or nursing facilities in 2020, suggesting success with avoiding transitional services in the right setting.

Passive Versus Active Intra-Abdominal Drainage Following Pancreatic Resection: Does A Superior Drainage System Exist? A Systematic Review and Meta-Analysis.

Postoperative pancreatic fistula (POPF) is a major source of morbidity following pancreatic resection. Surgically placed drains under suction or gravity are routinely used to help mitigate the complications associated with POPF. Controversy exists as to whether one of these drain management strategies is superior. The objective was to identify and compare the incidence of POPF, adverse events, and resource utilization associated with passive gravity (PG) versus active suction (AS) drainage following pancreatic resection. MEDLINE, EMBASE, CINAHL, and Cochrane Library databases were searched from inception to May 18, 2020. Outcomes of interest included POPF, post-pancreatectomy hemorrhage (PPH), surgical site infection (SSI), other major morbidity, and resource utilization. Descriptive qualitative and pooled quantitative meta-analyses were performed. One randomized control trial and five cohort studies involving 10 663 patients were included. Meta-analysis found no difference in the odds of developing POPF between AS and PG (p = 0.78). There were no differences in other endpoints including PPH (p = 0.58), SSI (wound p = 0.21, organ space p = 0.05), major morbidity (p = 0.71), or resource utilization (p = 0.72). The risk of POPF or other adverse outcomes is not impacted by drain management following pancreatic resection. Based on current evidence, a suggestion cannot be made to support the use of one drain over another at this time. There is a trend toward increased intra-abdominal wound infections with AS drains (p = 0.05) that merits further investigation.

Colonoscopy Trainers Experience Greater Stress During Insertion than Withdrawal: Implications for Endoscopic Curricula.

BACKGROUND: Optimal colonoscopy training curricula should minimize stress and cognitive load. This study aimed to determine whether withdrawal or insertion colonoscopy skills training is associated with less stress or cognitive load for trainees or trainers. METHODS: In Phase I, participants were randomized to train on either insertion or withdrawal in a simulated environment. In Phase II, participants were randomized to begin with either insertion or withdrawal in patient encounters. Salivary cortisol levels, heart rate, and State-Trait Anxiety Inventory (STAI) surveys were used to assess stress in trainees and trainers. NASA Task Load Index (TLX) survey was used to assess cognitive workload in trainees. RESULTS: In Phase I, trainee stress increased during the simulation training during both withdrawal and insertion compared to baseline, while trainer stress changed minimally. Cognitive load was higher for trainees during withdrawal (P = 0.005). In Phase II, trainers' STAI scores were greater during insertion training (P = 0.013). Trainees' stress was highest prior to beginning patient training and decreased during training, while trainer's stress increased during training. Trainees reported insertion training being of greater value (70.0%), while trainers reported withdrawal was preferred (77.8%). CONCLUSION: Trainees and trainers exhibit important differences in stress during colonoscopy skills training. Trainees reported more stress during simulation training and greatest cognitive load during simulation withdrawal, whereas trainers reported greatest stress during patient encounters, particularly training of insertion techniques. Attention to the effect of stress on trainees and trainers and the drivers of stress is warranted and could be incorporated in competency based medical education.

Evaluating bowel enterotomy closures in simulated deep body cavities using the reversing half-hitch alternating post and square knots: a randomized controlled trial.

Background: Square knots can be difficult to construct in deep body cavities. The reversing half-hitch alternating post (RHAP) surgical knot has noninferior tensile strength and performance characteristics in deep body cavities. We compared the enterotomy repairs of novice learners in simulated deep body cavities using RHAP versus square knots after proficiency-based training. Methods: Undergraduate students were randomized to RHAP (n = 10) or square knot (n = 10) groups and trained to defined proficiency. They then performed hand-sewn enterotomy repairs of cadaveric porcine small bowels on flat surfaces and in simulated deep body cavities. We recorded time to knot-tying proficiency and to enterotomy repair, and burst pressures for the repair. Results: Mean time-to-proficiency in knot tying was equivalent between the RHAP and square knot groups (23 [standard deviation (SD) 3] v. 21 [SD 2] min, p = 0.33). Mean time for enterotomy repair in deep cavities was shorter for the RHAP group (16 [SD 2] min v. 21 [SD 1] min, p = 0.02). Mean burst pressures for enterotomy repair were equivalent on flat surfaces (128 [SD 41] v. 101 [SD 36] mm Hg, p = 0.31), and were significantly higher for the RHAP group in simulated deep body cavities (32 [SD 13] v. 105 [SD 37] mm Hg, p = 0.05). Conclusion: The RHAP knots appear to have superior performance versus square knots when tied in a deep body cavity by novice learners. Future work should focus on demonstrating the clinical relevance and broad utility of the RHAP knot in abdominal surgery. Both knot types should be taught to novice learners.

Contexte: L'exécution de noeuds plats peut être difficile dans les cavités corporelles profondes. Les noeuds de type demi-clé inversée alternée (RHAP, pour reversing halfhitch alternating post) ont une résistance à la traction et un rendement semblables à ceux des noeuds plats dans ces cavités. Nous avons comparé l'efficacité des noeuds plats et des noeuds de type RHAP réalisés par de nouveaux apprenants dans des cavités profondes simulées, après leur avoir enseigné les compétences nécessaires. Méthodes: Les étudiants de premier cycle ont été aléatoirement répartis en 2 groupes, soit le groupe RHAP (n = 10) et le groupe noeud plat (n = 10), et ont reçu une formation pour développer des compétences prédéfinies. Ils ont ensuite suturé à la main un intestin grêle provenant d'un cadavre de porc, sur une surface plane et à l'intérieur d'une cavité profonde simulée. Nous avons mesuré le temps nécessaire à l'exécution du noeud et à la suture complète de l'incision, de même que la pression que pouvait subir cette suture sans se rompre. Résultats: Le temps moyen d'exécution du noeud était semblable entre les groupes RHAP et noeud plat (23 min [écart type (E.T.) 3 min] c. 21 min [E.T. 2 min]; p = 0,33). Le temps moyen nécessaire à la suture de l'incision dans la cavité profonde était plus court dans le groupe RHAP (16 min [E.T. 2 min] c. 21 min [E.T. 1 min]; p = 0,02). La pression moyenne que pouvait subir la suture sans se rompre était comparable pour les sutures effectuées sur une surface plane (128 mm Hg [E.T. 41 mm Hg] c. 101 mm Hg [E.T. 36 mm Hg]; p = 0,31), mais était significativement plus élevée dans le groupe RHAP pour les sutures faites dans la cavité profonde (32 mm Hg [E.T. 13 mm Hg] c. 105 mm Hg [E.T. 37 mm Hg], p = 0,05). Conclusion: Les noeuds de type RHAP semblent avoir un rendement supérieur à celui des noeuds plats lorsqu'ils sont réalisés dans une cavité profonde par de nouveaux apprenants. Des études ultérieures devraient se pencher sur la pertinence clinique et l'utilité générale de ces noeuds en chirurgie abdominale. Les 2 types de noeuds devraient être enseignés aux nouveaux apprenants.

Delayed vs. Early Appendectomy (DELAY) trial for adult patients with acute appendicitis: Study protocol for a randomized controlled trial.

INTRODUCTION: Early appendectomy in patients diagnosed with acute appendicitis is the current standard of treatment in North America. Timely intervention is suggested to avoid the complications associated with perforated appendicitis; however, safety of nighttime operating is a competing concern, with mixed results demonstrated thus far. OBJECTIVES: This multi-center prospective randomized controlled trial aims to assess whether delaying appendectomy until the following morning versus early appendectomy overnight affects the rate of surgical complications in adult patients diagnosed with acute appendicitis in the evening hours. METHODS: This is a randomized, controlled trial across two academic institutions with blinded outcome assessors. Patients presenting with imaging-confirmed appendicitis with an expected appendectomy between 8 pm and 4 am and within 6 h of decision to operate will be randomized to early appendectomy (with 6 h of randomization, control arm) or delayed to the following morning (after 6 am, intervention arm). Primary outcome will be 30 day postoperative complications, defined as a composite of: mortality, readmission to hospital, emergency department visit, percutaneous drain insertion, reoperation, prolonged hospital stay (>7 days), and postoperative complications. Secondary outcome measures are operative time, length of stay, time to emergency department visit and compliance to treatment. DISCUSSION: This is a feasible and pragmatic clinical trial, intended to provide evidence for challenging decision making for the most common surgical disease worldwide. Results of this study will aid surgeons and health care administrators on how to appropriately triage appendectomies for patients with acute appendicitis who present overnight.

The impact of tranexamic acid on administration of red blood cell transfusions for resection of colorectal liver metastases.

BACKGROUND: Red blood cell transfusions (RBCT) remain a concern for patients undergoing hepatectomy. The effect of tranexamic acid (TXA), an anti-fibrinolytic, on receipt of RBCT in colorectal liver metastases (CRLM) resection was examined. METHODS: Hepatectomies for CRLM over 2009-2014 were included. Primary outcome was 30-day receipt of RBCT. Secondary outcomes were 30-day major morbidity (Clavien-Dindo III-V) and 90-day mortality. Multivariable modelling examined the adjusted association between TXA and outcomes. RESULTS: Of 433 included patients, 146 (34%) received TXA. TXA patients were more likely to have inflow occlusion (41.8% vs. 23.1%; p < 0.01) and major hepatectomies (56.1% vs. 45.6%; p = 0.0193). TXA was independently associated with lower risk of RBCT (Relative risk (RR) 0.59; 95% confidence interval (95%CI): 0.42-0.85), but not with 30-day major morbidity (adjusted RR 1.02; 95%CI: 0.64-1.60) and 90-day mortality (univariable RR 0.99; 95%CI: 0.95-1.03). CONCLUSION: Intraoperative TXA was associated with a 41% reduction in risk of 30 -day receipt of RBCT after hepatectomy for CRLM. This finding is important to potentially improve healthcare resource allocation and patient outcomes. Pending further evidence, intraoperative TXA may be an effective method of reducing RBCT in hepatectomy for CRLM.

Passive Versus Active Intra-Abdominal Drainage Following Pancreaticoduodenectomy: A Retrospective Study Using The American College of Surgeons NSQIP Database.

BACKGROUND: Prophylactic drainage following pancreaticoduodenectomy (PD) reduces morbidity and mortality. Little evidence exists to advise on whether passive gravity (PG) or active suction (AS) drainage systems result in superior outcomes. This study examines the relationship between drainage system and morbidity following PD. METHODS: All patients undergoing elective PD with an operatively placed drain in the 2016 ACS-NSQIP database were included. Pre- and intra-operative factors were examined. Multivariable logistic regression and coarsened exact matching (CEM) were used to assess for an association between drainage system (PG vs. AS) and morbidity. The primary outcome was postoperative pancreatic fistula (POPF). RESULTS: In total, 3430 patients were included: 563 (16.4%) with PG and 2867 (83.6%) with AS drainage system. On multivariable regression, 1787 patients were included. Drainage type was not associated with POPF, surgical site infection, delayed gastric emptying, or re-operation. AS drainage was protective against percutaneous drain insertion (OR 0.65, 95% CI 0.44-0.96, p = 0.033). In the CEM cohort (n = 268), superficial SSI was higher in the AS group (0.8% vs. 6.0%, p = 0.036). There was a trend toward higher rates of composite total SSI (PG 15.7%, AS 23.9%, p = 0.092) and organ space SSI (PG 14.2%, AS 20.2%, p = 0.195) in the AS group; this did not demonstrate statistical significance. CONCLUSIONS: The findings of this study suggest that AS drainage is protective against percutaneous drain insertion, but may be associated with increased risk of SSI. There was no relation between drainage type and POPF. A prospective, randomized controlled trial is warranted to further explore these findings.

Optimizing resource utilization during proficiency-based training of suturing skills in medical students: a randomized controlled trial of faculty-led, peer tutor-led, and holography-augmented methods of teaching.

BACKGROUND: Suturing is a fundamental skill in undergraduate medical education. It can be taught by faculty-led, peer tutor-led, and holography-augmented methods; however, the most educationally effective and cost-efficient method for proficiency-based teaching of suturing is yet to be determined. METHODS: We conducted a randomized controlled trial comparing faculty-led, peer tutor-led, and holography-augmented proficiency-based suturing training in pre-clerkship medical students. Holography-augmented training provided holographic, voice-controlled instructional material. Technical skill was assessed using hand motion analysis every ten sutures and used to construct learning curves. Proficiency was defined by one standard deviation within average faculty surgeon performance. Intervention arms were compared using one-way ANOVA of the number of sutures placed, full-length sutures used, time to proficiency, and incremental costs incurred. Surveys were used to evaluate participant preferences. RESULTS: Forty-four students were randomized to the faculty-led (n = 16), peer tutor-led (n = 14), and holography-augmented (n = 14) intervention arms. At proficiency, there were no differences between groups in the number of sutures placed, full-length sutures used, and time to achieve proficiency. The incremental costs of the holography-augmented method were greater than faculty-led and peer tutor-led instruction ($247.00 ± $12.05, p < 0.001) due to the high cost of the equipment. Faculty-led teaching was the most preferred method (78.0%), while holography-augmented was the least preferred (0%). 90.6% of students reported high confidence in performing simple interrupted sutures, which did not differ between intervention arms (faculty-led 100.0%, peer tutor-led 90.0%, holography-augmented 83.3%, p = 0.409). 93.8% of students felt the program should be offered in the future. CONCLUSION: Faculty-led and peer tutor-led instructional methods of proficiency-based suturing teaching were superior to holography-augmented method with respect to costs and participants' preferences despite being educationally equivalent.

The role of sex in the outcomes of patients with biliary tract cancers remains unclear: A population-based study.

BACKGROUND: Differences in outcomes between males and females with biliary tract cancer (BTC) has been previously reported but not studied. METHODS: This was a population-based retrospective cohort study of patients undergoing BTC resection in Ontario between 2002 and 2012. Descriptive statistics on patient, disease, and treatment-related factors in each BTC subtype were reported. Kaplan Meier Curves and Cox Proportional Hazards analysis were used to examine the univariate relationship between sex and overall survival. RESULTS: 714 patients underwent resection of a BTC. Kaplan Meier Curves shows trends towards different survival for males and females in different BTC subtypes: improved for females with intrahepatic and ampullary cancers and poorer survival for females with perhilar and distal cholangiocarcinomas. These trends were not statistically significant. CONCLUSIONS: Sex may be an important factor in overall survival following resection of BTC. Further work is needed to better characterize the relationship between sex and outcomes of BTC.

Three point transfusion risk score in hepatectomy: an external validation using the American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP).

BACKGROUND: Risk of red blood cell transfusion (RBCT) in partial hepatectomy is 17-27%; strategies to reduce transfusions can be targeted in patients at increased risk. A Three Point Transfusion Risk Score (TRS) was previously developed to predict patients' risk of transfusion during and following hepatectomy. Here, it was subject to external validation using the ACS-NSQIP database. METHODS: TRIPOD guidelines were followed. A validation cohort was created with the ACS-NSQIP dataset. Risk groups for RBCT were created using the TRS: anemia (hematocrit ≤36%), major liver resection (≥4 segments) and primary liver malignancy. Concordance index was used to assess the discrimination. The Hosmer-Lemeshow test for goodness of fit and calibration curves were used to assess calibration. RESULTS: Of 2854 hepatectomies, 18.9% received RBCT. The TRS stratified patients from low (8.5% risk of RBCT) to very high risk (40.6%) of RBCT. The concordance was 0.68 (95% CI 0.66-0.70). Hosmer-Lemeshow test and calibration curves supported good predictive performance of the model. CONCLUSION: The TRS adequately discriminated risk of RBCT in an external sample of patients undergoing hepatectomy. It provides a simple method to identify patients at high transfusion risk. It can be used to tailor patient blood management initiatives and reduce the use of RBCT.

Elevated Lactate is Independently Associated with Adverse Outcomes Following Hepatectomy.

BACKGROUND: Arterial lactate is frequently monitored to indicate tissue hypoxia and direct therapy. We sought to determine whether early post-hepatectomy lactate (PHL) is associated with adverse outcomes and define factors associated with PHL. METHODS: Hepatectomy patients at a single institution from 2003 to 2012 with PHL available were included. Univariable and multivariable analyses examined factors associated with PHL and the relationship between PHL and 30-day major morbidity (Clavien grade III-V), 90-day mortality, and length of stay (LOS). RESULTS: Of 749 hepatectomies, 490 were included of whom 71.4% had elevated PHL (≥2 mmol/L). Cirrhosis (coefficient 0.31, p = 0.039), Charlson comorbidity index (coefficient 0.05, p < 0.001), major resections (coefficient 0.34, p < 0.001), procedure time (coefficient 0.08, p < 0.001), and blood loss (coefficient 0.11, p < 0.001) were associated with PHL. As lactate increased from <2 to ≥6 mmol/L, morbidity rose from 11.6 to 40.6%, and mortality from 0.7 to 22.7%. PHL was independently associated with 90-day mortality (OR 1.52 p < 0.001) and 30-day morbidity (OR 1.19, p = 0.002), but not LOS (rate ratio 1.03, p = 0.071). CONCLUSION: Patients with elevated PHL in the initial postoperative period should be carefully monitored due to increased risk of major morbidity and mortality. Further research on the impact of lactate-directed fluid therapy is warranted.

Validation of clinical risk score for colorectal liver metastases resected in a contemporary multicenter cohort.

BACKGROUND: Recent advances in care for colorectal liver metastases (CRLM) have lengthened 5-year survival. In this new era, prognostic tools such as the clinical risk score (CRS) for colorectal liver metastases require reevaluation. METHODS: Patients undergoing resection for CRLM between 2008 and 2012 at 4 specialty hepatobiliary centers in Canada (N = 740) were stratified by CRS and analyzed in Kaplan-Meier survival curves. Primary outcome of overall survival (OS) and secondary outcome of recurrence-free survival (RFS). Multivariate Cox regression compared CRS to patient factors. RESULTS: Median OS not reached (>60 months), median RFS 16 months. Original CRS strata was a significant (p < 0.001) predictor of both OS (5-year OS: 0; 75%, 1; 71%, 2; 57%, 3; 57%, 4; 46%) and RFS (5-year RFS: 0; 39%, 1; 33%, 2; 21%, 3; 21%, 4; 8%). The presence of extrahepatic colorectal metastatic disease increased recurrence risk (RFS hazard ratio of 1.32 (1.06-1.65)), and the use of intraoperative portal pedicle clamping reduced recurrence risk (RFS hazard ratio of 0.78 (0.61-0.99)). CONCLUSIONS: The CRS remains a relevant tool for predicting long-term outcomes for patients undergoing resection of CRLM. Additional factors such as the presence of extrahepatic colorectal metastatic disease and the use of intraoperative portal pedicle clamping may improve the prognostic power of the CRS.

Pasireotide for the Prevention of Pancreatic Fistula Following Pancreaticoduodenectomy: A Cost-effectiveness Analysis.

OBJECTIVE: To determine the cost-effectiveness of perioperative administration of pasireotide for reduction of pancreatic fistula (PF). SUMMARY: PF is a major complication following pancreaticoduodenectomy (PD), associated with significant morbidity and healthcare-related costs. Pasireotide is a novel multireceptor ligand somatostatin analogue, which has been demonstrated to reduce the incidence of PF following pancreas resection; however, the drug cost is significant. This study sought to estimate the cost-effectiveness of routine administration of pasireotide to patients undergoing PD, compared with no intervention from the perspective of the hospital system. METHODS: A decision-analytic model was developed to compare costs for perioperative administration of pasireotide versus no pasireotide. The model was populated using an institutional database containing all PDs performed 2002 to 2012 at a single institution, including data regarding clinically significant PF (International Study Group on Pancreatic Fistula Grade B or C) and hospital-related inpatient costs for 90 days following PD, converted to 2014 $USD. Relative risk of PF associated with pasireotide was estimated from the published literature. Deterministic and probabilistic sensitivity analyses were performed to test robustness of the model. RESULTS: Mean institutional cost of index admissions was $67,417 and $31,950 for patients with and without PF, respectively. Pasireotide was the dominant strategy, associated with savings of $1685, and a mean reduction of 1.5 days length of stay. Univariate sensitivity analyses demonstrated cost-savings down to a PF rate of 5.6%, up to a relative risk of PF of 0.775, and up to a drug cost of $2817. Probabilistic sensitivity analysis showed 79% of simulations were cost saving. CONCLUSIONS: Pasireotide appears to be a cost-saving treatment following PD across a wide variation of clinical and cost scenarios.

Patient Adherence and Experience with Extended Use of Prophylactic Low-Molecular-Weight Heparin Following Pancreas and Liver Resection.

BACKGROUND: Guidelines recommend 28 days venous thromboembolism (VTE) prophylaxis with low-molecular-weight heparin (LMWH) following major abdominal surgery for cancer. Overall adherence with these recommendations is poor, but little is known about feasibility and tolerability from a patient perspective. METHODS: An institution-wide policy for routine administration of 28 days of post-operative LMWH following major hepatic or pancreatic resection for cancer was implemented in April 2013. Patients having surgery from July 2013 to June 2015 were approached to participate in an interview examining adherence and experience with extended duration LMWH. RESULTS: There were 100 patients included, with 81.4 % reporting perfect adherence with the regimen. The most frequent reasons for non-adherence were that a healthcare provider stopped the regimen or because of poor experience with injections. Most patients were able to correctly recall the reason for being prescribed LMWH (82.6 %), and 78.4 % of patients performed all injections themselves. Over half the patients (55.7 %) did not find the injections bothersome. CONCLUSION: Patients reported high adherence and a manageable experience with post-operative extended-duration LMWH in an ambulatory setting following liver or pancreas resection. These findings suggest that patient adherence is not a major contributor to poor compliance with VTE prophylaxis guidelines.

A decision model and cost analysis of intra-operative cell salvage during hepatic resection.

BACKGROUND: Intraoperative cell salvage (ICS) can reduce allogeneic transfusions but with notable direct costs. This study assessed whether routine use of ICS is cost minimizing in hepatectomy and defines a subpopulation of patients where ICS is most cost minimizing based on patient transfusion risk. METHODS: A decision model from a health systems perspective was developed to examine adoption and non-adoption of ICS use for hepatectomy. A prospectively maintained database of hepatectomy patients provided data to populate the model. Probabilistic sensitivity analysis was used to determine the probability of ICS being cost-minimizing at specified transfusion risks. One-way sensitivity analysis was used to identify factors most relevant to institutions considering adoption of ICS for hepatectomies. RESULTS: In the base case analysis (transfusion risk of 28.8%) the probability that routine utilization of ICS is cost-minimizing is 64%. The probability that ICS is cost-minimizing exceeds 50% if the patient transfusion risk exceeds 25%. The model was most sensitive to patient transfusion risk, variation in costs of allogeneic blood, and number of appropriate cases the device could be used for. CONCLUSIONS: ICS is cost-minimizing for routine use in liver resection, particularly when used for patients with a risk of transfusion of 25% or greater.

The Effect of Early Postoperative Non-Steroidal Anti-Inflammatory Drugs on Pancreatic Fistula Following Pancreaticoduodenectomy.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are used commonly for postoperative analgesia but can potentially impair healing. Their effect on pancreaticoduodenectomy (PD) outcomes is unknown. We sought to examine the impact of early postoperative NSAIDs on pancreatic fistula (PF) after PD. METHODS: We reviewed our prospective pancreatectomy database supplemented by medication administration records, including all PDs from 2002 to 2012. Primary outcome was occurrence of clinically significant (grade B-C) PF. Secondary outcomes included major morbidity (Clavien grade III-V) and 90-day mortality. Patients were compared based on early postoperative NSAID use (first 3 days following surgery) using univariate and multivariate analyses. Subgroup analyses were conducted based on NSAID type (COX-2 inhibitors and non-selective inhibitors). RESULTS: We included 251 PDs, of whom 127 (50.6%) patients received NSAIDs postoperatively (35.5% COX-2 inhibitors, 18.3% non-selective inhibitors, and 4.4% both). Use of any NSAIDs was associated with a non-significant increase in PF (16.5 vs 11.3%%; p = 0.23), and no difference in major morbidity and mortality. Use of non-selective inhibitors was not associated with an increase in PF (8.7 vs 15.1%; p = 0.256). COX-2 inhibitors were associated with increased PF (20.2 vs 10.5 %; p = 0.033), but no difference in major morbidity or mortality. After adjusting for Charlson comorbidity and estimated blood loss, use of COX-2 inhibitors was independently associated with PF (odds ratio 2.12; p = 0.044). CONCLUSIONS: COX-2 inhibitors are associated with PF in the early postoperative period. While non-selective inhibitors appear safe in this setting, caution is warranted with the use of COX-2 inhibitors.

Symptom clusters using the Spitzer quality of life index in patients with brain metastases--a reanalysis comparing different statistical methods.

PURPOSE: The purpose of this paper is to determine whether the use of three different statistical methods influences the composition of symptom clusters derived from patients with brain metastases. MATERIALS AND METHODS: The dataset previously compiled from 129 brain metastases patients who completed the Spitzer Quality of Life Index (SQLI) and an additional study-designed 17-item symptom questionnaire was employed in this study. Symptom clusters extracted using principal component analysis in our previous study were compared to clusters determined using hierarchical cluster analysis and exploratory factor analysis. Clusters were identified using the three statistical methods at baseline, and at 1, 2, and 3 months following whole brain radiotherapy. RESULTS: The number and composition of symptom clusters at each time point varied based on the statistical method employed, despite the use of an identical dataset. However, some domains consistently clustered together, such as activity and daily living from the SQLI items. Of the 17 additional symptoms, memory loss, confusion, and trouble concentrating were always present in the same cluster. Nausea and vomiting also occurred in conjunction regardless of the analytical method employed. CONCLUSION: Symptom clusters vary with respect to occurrence, quantity, and composition based on the statistical method utilized to extract them. Further studies should be conducted to determine an ideal statistical method in order to select the optimal method to employ. The use of a single analytical method is essential for consistency and comparison purposes in future symptom cluster research.

Symptom clusters in patients with metastatic cancer: a literature review.

This article reviews the literature reporting empirically determined symptom clusters in patients with metastatic cancer. A literature search was conducted on symptom clusters within heterogeneous metastatic cancer patient populations using MEDLINE, EMBASE, and CINAHL. Studies examining predetermined symptom clusters were excluded. A total of eight relevant studies published between 2005 and 2011 were identified. The number of symptom clusters extracted varied from two to eight clusters per study, comprising of two to eight symptoms per cluster. There were no clusters consistently identified within all eight studies. Notable differences in symptoms assessed, assessment tools, statistical analysis, patient demographics were observed between the studies. The lack of consensus among the inter-study symptom clusters are likely due to the differences in patient population as well as study methodology. Further exploration in metastatic symptom cluster research will ideally improve patient outcomes by facilitating improved symptom management in future clinical practice.