A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis.

BACKGROUND: Antibiotic therapy has been proposed as an alternative to surgery for the treatment of appendicitis. METHODS: We conducted a pragmatic, nonblinded, noninferiority, randomized trial comparing antibiotic therapy (10-day course) with appendectomy in patients with appendicitis at 25 U.S. centers. The primary outcome was 30-day health status, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire (scores range from 0 to 1, with higher scores indicating better health status; noninferiority margin, 0.05 points). Secondary outcomes included appendectomy in the antibiotics group and complications through 90 days; analyses were prespecified in subgroups defined according to the presence or absence of an appendicolith. RESULTS: In total, 1552 adults (414 with an appendicolith) underwent randomization; 776 were assigned to receive antibiotics (47% of whom were not hospitalized for the index treatment) and 776 to undergo appendectomy (96% of whom underwent a laparoscopic procedure). Antibiotics were noninferior to appendectomy on the basis of 30-day EQ-5D scores (mean difference, 0.01 points; 95% confidence interval [CI], -0.001 to 0.03). In the antibiotics group, 29% had undergone appendectomy by 90 days, including 41% of those with an appendicolith and 25% of those without an appendicolith. Complications were more common in the antibiotics group than in the appendectomy group (8.1 vs. 3.5 per 100 participants; rate ratio, 2.28; 95% CI, 1.30 to 3.98); the higher rate in the antibiotics group could be attributed to those with an appendicolith (20.2 vs. 3.6 per 100 participants; rate ratio, 5.69; 95% CI, 2.11 to 15.38) and not to those without an appendicolith (3.7 vs. 3.5 per 100 participants; rate ratio, 1.05; 95% CI, 0.45 to 2.43). The rate of serious adverse events was 4.0 per 100 participants in the antibiotics group and 3.0 per 100 participants in the appendectomy group (rate ratio, 1.29; 95% CI, 0.67 to 2.50). CONCLUSIONS: For the treatment of appendicitis, antibiotics were noninferior to appendectomy on the basis of results of a standard health-status measure. In the antibiotics group, nearly 3 in 10 participants had undergone appendectomy by 90 days. Participants with an appendicolith were at a higher risk for appendectomy and for complications than those without an appendicolith. (Funded by the Patient-Centered Outcomes Research Institute; CODA ClinicalTrials.gov number, NCT02800785.).

Intraoperative cholangiography: a stepping stone to streamlining the treatment of choledocholithiasis.

BACKGROUND: An estimated 8-15% of patients undergoing cholecystectomy have concomitant common bile duct stones. In this 14-year study, we utilize data of patients at a high-volume tertiary care academic center and compare the clinical outcomes of patients undergoing intraoperative cholangiography (IOC) and endoscopic retrograde pancreatography (ERCP). METHODS: The charts of 1715 patients in the institutional NSQIP database who underwent cholecystectomy between October 1st, 2005 and September 30th, 2019 were retrospectively reviewed. Patients who underwent cholecystectomy in relation to a malignancy diagnosis or who underwent an ERCP in a different index hospitalization were excluded. Main outcomes included hospital length of stay (LOS), post-operative morbidity, and rate of readmissions. RESULTS: Of the 1409 patients included in the final analysis, 185 patients underwent ERCP, while 95 patients underwent IOC. Use of IOC compared to preoperative ERCP resulted in a shorter LOS (2.6 vs. 5.3 days, p < 0.001), lower rate of readmission (1.1% vs. 6.5%, p = 0.040), and similar rates of post-operative complications. Mean operative time increased by only 15 min in the IOC compared to the ERCP group (129 vs.114 min, p = 0.047). Additional variables that increased LOS on multivariable logistic regression included age, ASA classification, post-operative complications, and increased number of preoperative tests. CONCLUSIONS: This study demonstrates that use of IOC during cholecystectomy results in shorter LOS and fewer readmissions compared to ERCP. Future studies comparing these two approaches should focus on patient randomization, a cost-effectiveness analysis, and identifying barriers to implementation of a one-stage approach in the management of suspected choledocholithiasis.

Novel Method Suggests Global Superiority of Short-Duration Antibiotics for Intra-abdominal Infections.

Desirability of outcome ranking and response adjusted for duration of antibiotic risk (DOOR/RADAR) are novel and innovative methods of evaluating data in antibiotic trials. We analyzed data from a noninferiority trial of short-course antimicrobial therapy for intra-abdominal infection (STOP-IT), and results suggest global superiority of short-duration therapy for intra-abdominal infections.

Quantifying the Prognostic Value of Preoperative Surgeon Intuition: Comparing Surgeon Intuition and Clinical Risk Prediction as Derived from the American College of Surgeons NSQIP Risk Calculator.

BACKGROUND: Surgical risk prediction models traditionally use patient attributes and measures of physiology to generate predictions about postoperative outcomes. However, the surgeon's assessment of the patient may be a valuable predictor, given the surgeon's ability to detect and incorporate factors that existing models cannot capture. We compare the predictive utility of surgeon intuition and a risk calculator derived from the American College of Surgeons (ACS) NSQIP. STUDY DESIGN: From January 10, 2021 to January 9, 2022, surgeons were surveyed immediately before performing surgery to assess their perception of a patient's risk of developing any postoperative complication. Clinical data were abstracted from ACS NSQIP. Both sources of data were independently used to build models to predict the likelihood of a patient experiencing any 30-day postoperative complication as defined by ACS NSQIP. RESULTS: Preoperative surgeon assessment was obtained for 216 patients. NSQIP data were available for 9,182 patients who underwent general surgery (January 1, 2017 to January 9, 2022). A binomial regression model trained on clinical data alone had an area under the receiver operating characteristic curve (AUC) of 0.83 (95% CI 0.80 to 0.85) in predicting any complication. A model trained on only preoperative surgeon intuition had an AUC of 0.70 (95% CI 0.63 to 0.78). A model trained on surgeon intuition and a subset of clinical predictors had an AUC of 0.83 (95% CI 0.77 to 0.89). CONCLUSIONS: Preoperative surgeon intuition alone is an independent predictor of patient outcomes; however, a risk calculator derived from ACS NSQIP is a more robust predictor of postoperative complication. Combining intuition and clinical data did not strengthen prediction.

The Effect of Anticoagulation and Antiplatelet Use in Trauma Patients on Mortality and Length of Stay.

BACKGROUND: Though many trauma patients are on anticoagulation or antiplatelet therapy (AAT), there are few generalizable data on the risks for these patients. The purpose of this study was to analyze the impact of anticoagulation (AC) and antiplatelet (AP) therapy on mortality and length of stay (LOS) in general trauma patients. METHODS: A retrospective review was performed of patients in the institutional trauma registry during 2019 to determine AAT use on admission and discharge. Outcomes were compared using standard statistics. RESULTS: Of 2261 patients who met the inclusion criteria, 2 were excluded due to an incomplete medication reconciliation, resulting in 2259 patients. Patients on AAT had a higher mortality (4.5% vs 2.1%). On multivariable analysis, preadmission AC (odds ratio OR, 3.325, P = .001), age (OR 1.040, P < .001), and injury severity score ((ISS) 1.094, P < .001) were associated with mortality. Anticoagulation use was also associated with longer LOS on multivariable analysis (OR: 1.626, P = .005). Antiplatelet use was not associated with higher mortality or longer LOS. More patients on AAT were unable to be discharged home. However, patients on AAT did not have a greater blood transfusion requirement or need more hemorrhage control procedures. Lastly, 23.7% of patients on preadmission AAT were not discharged on any AAT. DISCUSSION: These data demonstrate that patients on AC, but not AP, have greater mortality and longer hospital LOS. This may provide guidance for those being newly started on AAT. Further work to determine which patients benefit most from restarting AAT would lead to improvement in the care of trauma patients.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Importance: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. Objective: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. Design, Setting, and Participants: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. Interventions: Appendectomy vs antibiotics. Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. Results: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. Conclusions and Relevance: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.

IMPORTANCE: Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making. OBJECTIVE: To assess patient factors associated with undergoing appendectomy within 30 days of initiating antibiotics for appendicitis. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial, characteristics among patients who initiated antibiotics were compared between those who did and did not undergo appendectomy within 30 days. The study was conducted at 25 US medical centers; participants were enrolled between May 3, 2016, and February 5, 2020. A total of 1552 participants with acute appendicitis were randomized to antibiotics (776 participants) or appendectomy (776 participants). Data were analyzed from September 2020 to July 2021. EXPOSURES: Appendectomy vs antibiotics. MAIN OUTCOMES AND MEASURES: Conditional logistic regression models were fit to estimate associations between specific patient factors and the odds of undergoing appendectomy within 30 days after initiating antibiotics. A sensitivity analysis was performed excluding participants who underwent appendectomy within 30 days for nonclinical reasons. RESULTS: Of 776 participants initiating antibiotics (mean [SD] age, 38.3 [13.4] years; 286 [37%] women and 490 [63%] men), 735 participants had 30-day outcomes, including 154 participants (21%) who underwent appendectomy within 30 days. After adjustment for other factors, female sex (odds ratio [OR], 1.53; 95% CI, 1.01-2.31), radiographic finding of wider appendiceal diameter (OR per 1-mm increase, 1.09; 95% CI, 1.00-1.18), and presence of appendicolith (OR, 1.99; 95% CI, 1.28-3.10) were associated with increased odds of undergoing appendectomy within 30 days. Characteristics that are often associated with increased risk of complications (eg, advanced age, comorbid conditions) and those clinicians often use to describe appendicitis severity (eg, fever: OR, 1.28; 95% CI, 0.82-1.98) were not associated with odds of 30-day appendectomy. The sensitivity analysis limited to appendectomies performed for clinical reasons provided similar results regarding appendicolith (adjusted OR, 2.41; 95% CI, 1.49-3.91). CONCLUSIONS AND RELEVANCE: This cohort study found that presence of an appendicolith was associated with a nearly 2-fold increased risk of undergoing appendectomy within 30 days of initiating antibiotics. Clinical characteristics often used to describe severity of appendicitis were not associated with odds of 30-day appendectomy. This information may help guide more individualized decision-making for people with appendicitis.

Cervical spine MRI in patients with negative CT: A prospective, multicenter study of the Research Consortium of New England Centers for Trauma (ReCONECT).

BACKGROUND: Although cervical spine CT (CSCT) accurately detects bony injuries, it may not identify all soft tissue injuries. Although some clinicians rely exclusively on a negative CT to remove spine precautions in unevaluable patients or patients with cervicalgia, others use MRI for that purpose. The objective of this study was to determine the rates of abnormal MRI after a negative CSCT. METHODS: Blunt trauma patients who either were unevaluable or had persistent midline cervicalgia and underwent an MRI of the C-spine after a negative CSCT were enrolled prospectively in eight Level I and II New England trauma centers. Demographics, injury patterns, CT and MRI results, and any changes in cervical spine management as a result of MRI imaging were recorded. RESULTS: A total of 767 patients had MRI because of cervicalgia (43.0%), inability to evaluate (44.1%), or both (9.4%). MRI was abnormal in 23.6% of all patients, including ligamentous injury (16.6%), soft tissue swelling (4.3%), vertebral disc injury (1.4%), and dural hematomas (1.3%). Rates of abnormal neurological signs or symptoms were not different among patients with normal versus abnormal MRI. (15.2 vs. 18.8%, p = 0.25). The c-collar was removed in 88.1% of patients with normal MRI and 13.3% of patients with an abnormal MRI. No patient required halo placement, but 11 patients underwent cervical spine surgery after the MRI results. Six of the eleven had neurological signs or symptoms. CONCLUSIONS: In a select population of patients, MRI identified additional injuries in 23.6% of patients despite a normal CSCT. It is uncertain if this is a true limitation of CT technology or represents subtle injuries missed in the interpretation of the scan. The clinical significance of these abnormal MRI findings cannot be determined from this study group. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Lithopedion presenting as intra-abdominal abscess and fecal fistula: report of a case and review of the literature.

A rare case of unrecognized and long-standing lithopedion ("stone baby") with erosion into the bowel with fecal fistula formation is described. A literature review is also presented.

Diabetes insipidus uncovered during conservative management of complicated acute appendicitis.

Diabetes insipidus (DI) arises from impaired function of antidiuretic hormone, characterized by hypovolemia, hypernatremia, polyuria, and polydipsia. This case is a reminder of the rare but challenging obstacle that undiagnosed DI poses in fasting surgical patients, requiring prompt recognition and vigilant management of marked homeostatic imbalances.

Extremes of shock index predicts death in trauma patients.

CONTEXT: We noted a bimodal relationship between mortality and shock index (SI), the ratio of heart rate to systolic blood pressure. AIMS: To determine if extremes of SI can predict mortality in trauma patients. SETTINGS AND DESIGNS: Retrospective evaluation of adult trauma patients at a tertiary care center from 2000 to 2012 in the United States. MATERIALS AND METHODS: We examined the SI in trauma patients and determined the adjusted mortality for patients with and without head injuries. STATISTICAL ANALYSIS USED: Descriptive statistics and multivariable logistic regression. RESULTS: SI values demonstrated a U-shaped relationship with mortality. Compared with patients with a SI between 0.5 and 0.7, patients with a SI of <0.3 had an odds ratio for death of 2.2 (95% confidence interval [CI] 21.2-4.1) after adjustment for age, Glasgow Coma score, and injury severity score while patients with SI >1.3 had an odds ratio of death of 3.1. (95% CI 1.6-5.9). Elevated SI is associated with increased mortality in patients with isolated torso injuries, and is associated with death at both low and high values in patients with head injury. CONCLUSION: Our data indicate a bimodal relationship between SI and mortality in head injured patients that persists after correction for various co-factors. The distribution of mortality is different between head injured patients and patients without head injuries. Elevated SI predicts death in all trauma patients, but low SI values only predict death in head injured patients.

The rate of adenocarcinoma in endoscopically removed colorectal polyps.

The purpose of this study was to determine the rate of cancer in a modern series of colorectal polyps. All pathology reports from colon and rectal polyps from 1999 to 2002 were reviewed. Reports of bowel resections, cancer-free polyps, and polyp-free mucosal biopsies were excluded. Polyps were grouped by size, and the rate of adenocarcinoma was determined. x2 was used for analysis. A total of 4,443 polyps were found, of which 3,225 were adenomatous [2,883 (89.4%) tubular adenomas, 399 (9.3%) tubulo-villous adenomas, 32 (1.0%) villous adenomas, and 11 (0.3%) carcinomas]. The rate of adenocarcinoma by size was 0.07 per cent for polyps <1 cm, 2.41 per cent for polyps 1-2 cm, and 19.35 per cent for polyps >2 cm, representing significantly fewer cancers for each category of polyp size than the accepted standard. The rate of carcinoma in colon polyps is much lower than previously thought and currently stated in many texts. These data do not alter the recommendations for polyp removal, however, failure to retrieve a specimen in a polyp <1 cm in size is unlikely to have an adverse outcome because the chances of malignancy are very low.

Evidence-based medicine applied to sentinel lymph node biopsy in patients with breast cancer.

Sentinel lymph node biopsy (SLNB) has not been examined using the principles of evidence-based medicine (EBM). Specifically, likelihood ratios have not been used to assess the validity of SLNB. The Surveillance, Epidemiology, and End Results (SEER) public database of the National Cancer Institute was used to establish the baseline or pretest probability of finding a positive lymph axillary node for each stage of breast cancer. Rates of false negative results of SLNB for all breast cancer stages were determined from the surgical literature. Positive and negative likelihood ratios (LR) were calculated. For each stage of breast cancer, the Bayesian nomogram was used to find the post-test probability of missing a metastatic axillary node when the SLN was negative. The SEER database of 213,292 female patients with breast cancer yielded the following rates of positivity of axillary lymph nodes for each breast tumor size: T1a, 7.8 per cent; T1b, 13.3 per cent; T1c, 28.5 per cent; T2, 50.2 per cent; T3, 70.1 per cent. The combined data from 13 published studies of SLNB (6444 successful SLNBs) demonstrated a false negative rate of 8.5 per cent. The LR of a negative test is 0.086. According to the nomogram, the chances of missing a positive node for stage of cancer are as follows: T1a, 0.7 per cent; T1b, 1.5 per cent; T1c, 3.0 per cent; T2, 7 per cent; T3, 18 per cent. The risk of missing a positive axillary node can accurately be estimated for each stage of breast cancer using the LR, which is much more useful than the simple false negative rate. Surgeons should use this information when deciding whether to perform SLNB and in their informed consent discussions.

Pathologic findings suggest long-term abnormality after conservative management of complex acute appendicitis.

Perforated or phlegmonous appendicitis is often treated with antibiotics and drainage as needed. The rationale, risk of recurrence, timing, or even the necessity of subsequent elective interval appendectomy (IA) is debated. We retrospectively reviewed all appendectomies performed at Beth Israel Deaconess Medical Center between 1997 and 2011. We determined if the appendix was removed emergently or as IA. Demographic characteristics, hospital length of stay, computed tomography (CT) results, and operation type (open or laparoscopic) were determined. In IA specimens, narrative pathology reports were assessed for evidence of anatomic, acute, or chronic abnormality. A total of 3562 patients had their appendix removed during this time period. Thirty-four patients were identified as having IA. Of these, only three (8.8%) had a pathologically normal appendix. All three patients were female and all had initially abnormal CT scans. Eight specimens (23.5%) had evidence of chronic and 10 (29.4%) had evidence of acute appendicitis. An additional 10 (29.4%) specimens contained a combination of acute and chronic inflammation. Mean time to operation in the IA group was 57.1 days (range, nine to 234 days) after index diagnosis by CT scan. Given the high percentage of IA specimens with acute or chronic appendicitis and the extremely high proportion (91%) of patients with pathologically abnormal specimens, it appears that IA may be justified in most cases.

Automated analysis of vital signs to identify patients with substantial bleeding before hospital arrival: a feasibility study.

Trauma outcomes are improved by protocols for substantial bleeding, typically activated after physician evaluation at a hospital. Previous analysis suggested that prehospital vital signs contained patterns indicating the presence or absence of substantial bleeding. In an observational study of adults (aged ≥18 years) transported to level I trauma centers by helicopter, we investigated the diagnostic performance of the Automated Processing of the Physiological Registry for Assessment of Injury Severity (APPRAISE) system, a computational platform for real-time analysis of vital signs, for identification of substantial bleeding in trauma patients with explicitly hemorrhagic injuries. We studied 209 subjects prospectively and 646 retrospectively. In our multivariate analysis, prospective performance was not significantly different from retrospective. The APPRAISE system was 76% sensitive for 24-h packed red blood cells of 9 or more units (95% confidence interval, 59% - 89%) and significantly more sensitive (P < 0.05) than any prehospital Shock Index of 1.4 or higher; sensitivity, 59%; initial systolic blood pressure (SBP) less than 110 mmHg, 50%; and any prehospital SBP less than 90 mmHg, 50%. The APPRAISE specificity for 24-h packed red blood cells of 0 units was 87% (88% for any Shock Index ≥1.4, 88% for initial SBP <110 mmHg, and 90% for any prehospital SBP <90 mmHg). Median APPRAISE hemorrhage notification time was 20 min before arrival at the trauma center. In conclusion, APPRAISE identified bleeding before trauma center arrival. En route, this capability could allow medics to focus on direct patient care rather than the monitor and, via advance radio notification, could expedite hospital interventions for patients with substantial blood loss.

Recurrence of a solitary fibrous tumor of the pleura: a case report.

We report a case of an 80-year-old female with two prior thoracotomies for benign solitary fibrous tumor of the pleura (SFTP) presenting with a two-month history of shortness of breath. Computed tomography revealed a pleural-based recurrence and operative excision revealed multiple adherent tumors throughout the thoracic cavity. Pathologic examination demonstrated malignant degeneration of this previously benign tumor. We consider the importance of recurrence of benign SFTP and the significance of surgical care and follow up of patients with this rare tumor.

Requirement for hourly Glasgow Coma Scores in the emergency department: process or outcome based?

BACKGROUND: The lack of hourly Glasgow Coma Score (GCS) documentation in trauma patients while in the emergency department (ED) is frequently cited by American College of Surgeons (ACS) Trauma Center Verification Review Committee site visitors. The basis for this requirement is unclear. We suspected that hourly recording of GCS has no impact on patient outcome. METHODS: The trauma registry of a 300-bed ACS-verified, state-designated Level II trauma center was reviewed retrospectively for head trauma patients over 16 years of age. Demographic data, field and ED GCS, presence or absence of hourly GCS in the ED, objective injury scores, complications, discharge status, and hospital length of stay were determined. RESULTS: A total of 463 patients were identified. Hourly GCS was recorded in the ED in 244 (53%) patients. No significant difference was found in the Trauma and Injury Severity Score or the Abbreviated Injury Score of the head between those who had hourly GCS recorded and those who did not. Patients who had hourly GCS recorded were significantly younger, 42.3 +/- 19.7 years vs 53.9 +/- 24.9 years for those who did not have hourly GCS recorded (P < 0.001). Seventy percent (126/179) of patients involved in a motorcycle or motor vehicle crash had hourly GCS recorded while only 39% (69/175) of patients admitted for falls had hourly GCS (P < 0.001). There were no differences in mortality or complication rates between the groups. CONCLUSION: The recording of hourly GCS on head injured patients is reflective of the initial presentation of the patient and not an objective evaluation of the patient. The presence or absence of hourly GCS in the ED was not associated with any increase in complications or mortality. The ACS should reevaluate the requirement for hourly recording of GCS in trauma patients.