Is nonoperative management of appendicitis inferior in the COVID-19 era?

BACKGROUND: Previous studies on nonoperative management (NOM) of acute appendicitis (AA) indicated comparable outcomes to surgery, but the effect of COVID-19 infection on appendicitis outcomes remains unknown. Thus, we evaluate appendicitis outcomes during the COVID-19 pandemic to determine the effect of COVID-19 infection status and treatment modality. We hypothesized that active COVID-19 patients would have worse outcomes than COVID-negative patients, but that outcomes would not differ between recovered COVID-19 and COVID-negative patients. Moreover, we hypothesized that outcomes would not differ between nonoperative and operative management groups, regardless of COVID-19 status. METHODS: We queried the National COVID Cohort Collaborative from 2020 to 2023 to identify adults with AA who underwent operative or NOM. COVID-19 status was denoted as follows: COVID-negative, COVID-active, or COVID-recovered. Intention to treat was used for NOM. Propensity score-balanced analysis was performed to compare outcomes within COVID groups, as well as within treatment modalities. RESULTS: A total of 37,868 patients were included: 34,866 COVID-negative, 2,540 COVID-active, and 460 COVID-recovered. COVID-active and recovered less often underwent operative management. Unadjusted, there was no difference in mortality between COVID groups for operative management. There was no difference in rate of failure of NOM between COVID groups. Adjusted analysis indicated, compared with operative, NOM carried higher odds of mortality and readmission for COVID-negative and COVID-active patients. CONCLUSION: This study demonstrates higher odds of mortality among NOM of appendicitis and near equivalent outcomes for operative management regardless of COVID-19 status. We conclude that NOM of appendicitis is associated with worse outcomes for COVID-active and COVID-negative patients. In addition, we conclude that a positive COVID test or recent COVID-19 illness alone should not preclude a patient from appendectomy for AA. Surgeon clinical judgment of a patient's physiology and surgical risk should, of course, inform the decision to proceed to the operating room. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Acute Care Surgery and Surgical Rescue: Expanding the Definition.

BACKGROUND: Surgical rescue (SR) is the recovery of patients with surgical complications. Patients transferred (TP) for surgical diagnoses to higher-level care or inpatients (IP) admitted to nonsurgical services may develop intra-abdominal infection (IAI) and require emergency surgery (ES). The aims were to characterize the SR population by the site of ES consultation, open abdomen (OA), and risk of mortality. STUDY DESIGN: This was an international, multi-institutional prospective observational study of patients requiring ES for IAI. Laparotomy before the transfer was an exclusion criterion. Patients were divided into groups: clinic/ED (C/ED), IP, or TP. Data collected included demographics, the severity of illness (SOI), procedures, OA, and number of laparotomies. The primary outcome was mortality. Multivariable logistic regression models were constructed. RESULTS: There were 752 study patients (C/ED 63.8% vs TP 23.4% and IP 12.8%), with a mean age of 59 years and 43.6% women. IP had worse SOI scores (Charlson Comorbidity Index, American Society of Anesthesiologists Physical Status Classification System, and Sequential Organ Failure Assessment). The most common procedures were small and large bowel (77.3%). IP and TP had similar rates of OA (IP 52.1% and TP 52.3 %) vs C/ED (37.7%, p < 0.001), and IP had more relaparotomies (3 or 4). The unadjusted mortality rate was highest in IP (n = 24, 25.0%) vs TP (n = 29, 16.5%) and C/ED (n = 68, 14.2%, p = 0.03). Adjusting for age and SOI, only SOI had an impact on the risk of mortality (area under the curve 86%). CONCLUSIONS: IP had the highest unadjusted mortality after ES for IAI and was followed by the TP; SOI drove the risk of mortality. SR must be extended to IP for timely recognition of the IAI.

Not All Fluid Collections Are Created Equal: Clinical Course and Outcomes of Pancreatic Pseudocysts and Acute Peripancreatic Fluid Collections Requiring Intervention.

BACKGROUND: Knowledge on pancreatic pseudocyst (PP) management has mostly involved large database analysis, which limits understanding of a complex and heterogeneous disease. We aimed to review the clinical course and outcomes of PP and acute peripancreatic fluid collections (APFC) that require intervention at 1 high-volume center. METHODS: Retrospective review of patients with APFC and PP undergoing drainage (2011-2018) was performed. Patients were divided into groups based on initial intervention: surgical (SR), percutaneous (PC), or endoscopic (EN) drainage. Primary outcome was mortality by initial intervention type. Secondary outcomes included subsequent interventions required, length of stay (LOS), readmission rates, and discharge disposition. RESULTS: Of 88 patients, 40 (46.1%) underwent SR, 40 (44.9%) PC, and 8 (9.0%) EN. No patients in EN group had APACHE II scores>20. Pancreatic necrosis was higher in SR (80.5%) and PC (62.5%) groups (P = .006). There were no differences in mortality, LOS, or readmission rates. Ten patients in the PC group underwent subsequent surgical intervention, of which 9 were due to bowel ischemia. The PC group was 3.4 times more likely to be discharged to rehabilitation over home when compared to the other 2 groups (P = .04). CONCLUSION: Patients undergoing surgical or percutaneous drainage of APFC and PP have a greater burden of illness and more local complications requiring intervention compared to endoscopic drainage. The heterogeneity in presentation of peripancreatic fluid collections in acute pancreatitis must be considered when evaluating the benefits of each intervention.

Open reduction internal fixation of rib fractures: a biomechanical comparison between the RibLoc U Plus® system and anterior plate in rib implants.

OBJECTIVES: In this study, we assessed the bending strength of two surgical repairs of rib fracture using RibLoc® U Plus system made by Acute Innovations and the anterior plate by Synthes. METHODS: After a rib fracture was created in seven pairs of cadaveric rib specimens, one side was repaired with the anterior plate and the other side repaired with the RibLoc U Plus® plate. Each of the rib is loaded using a custom device over 360,000 bending cycles to simulate in vivo fatiguing related to respiration. Upon completion of the cyclic loading, the specimens were compressively loaded to failure and the failure bending moment was determined. RESULTS: The ribs repaired with the RibLoc U Plus® system showed 79% higher failure bending moment than that of the anterior plate, with a p value of 0.033. The ribs repaired with RibLoc U Plus® showed a trend of less stiffness reduction over the 360,000 loading cycles. CONCLUSION: The biomechanical study showed that the RibLoc U Plus® system is stronger in the bending moment loading of repaired ribs, possibly due to the U-shape structure supporting both the inner and outer cortices of a repaired rib.

Cost Differences Between Teaching and Nonteaching Hospitals for Older Adults Requiring Emergency General Surgery Procedures in the State of Maryland.

BACKGROUND: Older adults (OAs; ≥ 65 years) comprise a growing population in the United States and are anticipated to require an increasing number of emergency general surgery procedures (EGSPs). The aims of this study were to identify the frequency of EGSPs and compare cost of care in OAs managed at teaching hospitals (THs) vs nonteaching hospitals (NTHs). METHODS: A retrospective review of data from the Maryland Health Services Cost Review Commission database from 2009 to 2018 for OAs undergoing EGSPs was undertaken. Data collected included demographics, all patient-refined (APR)-severity of illness (SOI), APR-risk of mortality (ROM), Charlson Comorbidity Index (CCI), EGSPs (partial colectomy (PC), small bowel resection, cholecystectomy, operative management of peptic ulcers, lysis of adhesions, appendectomy, and laparotomy, categorized hospital charges, length of stay (LOS), and mortality. RESULTS: Of the 55,401 OAs undergoing EGSPs in this study, 28,575 (51.6%) were treated at THs and 26,826 (48.4%) at NTHs. OAs at THs presented with greater APR-ROM (major 25.6% vs 24.9%, extreme 22.6% vs 22.0%, P=.01), and CCI (3.1±3 vs 2.7±2.8, P<.001) compared to NTHs. Lysis of adhesions, cholecystectomy, and PC comprised the overall most common EGSPs. Older adults at THs incurred comparatively higher median hospital charges for every EGSP due to increased room charges and LOS. Mortality was higher at THs (6.13% vs 5.33%, P<.001). CONCLUSION: While acuity of illness appears similar, cost of undergoing EGSPs for OAs is higher in THs vs NTHs due to increased LOS. Future work is warranted to determine and mitigate factors that increase LOS at THs.

Validation of the American Association for the Surgery of Trauma Emergency General Surgery Grading System for Colorectal Resection: An EAST Multicenter Study.

BACKGROUND: The American Association for the Surgery of Trauma (AAST) has developed a grading system for emergency general surgery (EGS) conditions. We sought to validate the AAST EGS grades for patients undergoing urgent/emergent colorectal resection. METHODS: Patients enrolled in the "Eastern Association for the Surgery of Trauma Multicenter Colorectal Resection in EGS-to anastomose or not to anastomose" study undergoing urgent/emergent surgery for obstruction, ischemia, or diverticulitis were included. Baseline demographics, comorbidity severity as defined by Charlson comorbidity index (CCI), procedure type, and AAST grade were prospectively collected. Outcomes included length of stay (LOS) in-hospital mortality, and surgical complications (superficial/deep/organ-space surgical site infection, anastomotic leak, stoma complication, fascial dehiscence, and need for further intervention). Multivariable logistic regression models were used to describe outcomes and risk factors for surgical complication or mortality. RESULTS: There were 367 patients, with a mean (± SD) age of 62 ± 15 years. 39% were women. The median interquartile range (IQR) CCI was 4 (2-6). Overall, the pathologies encompassed the following AAST EGS grades: I (17, 5%), II (54, 15%), III (115, 31%), IV (95, 26%), and V (86, 23%). Management included laparoscopic (24, 7%), open (319, 87%), and laparoscopy converted to laparotomy (24, 6%). Higher AAST grade was associated with laparotomy (P = .01). The median LOS was 13 days (8-22). At least 1 surgical complication occurred in 33% of patients and the mortality rate was 14%. Development of at least 1 surgical complication, need for unplanned intervention, mortality, and increased LOS were associated with increasing AAST severity grade. On multivariable analysis, factors predictive of in-hospital mortality included AAST organ grade, CCI, and preoperative vasopressor use (odds ratio (OR) 1.9, 1.6, 3.1, respectively). The American Association for the Surgery of Trauma emergency general surgery grade was also associated with the development of at least 1 surgical complication (OR 2.5), while CCI, preoperative vasopressor use, respiratory failure, and pneumoperitoneum were not. CONCLUSION: The American Association for the Surgery of Trauma emergency general surgery grading systems display construct validity for mortality and surgical complications after urgent/emergent colorectal resection. These results support incorporation of AAST EGS grades for quality benchmarking and surgical outcomes research.

Effect of Antibiotic Duration in Emergency General Surgery Patients with Intra-Abdominal Infection Managed with Open vs Closed Abdomen.

BACKGROUND: Data on duration of antibiotics in patients managed with an open abdomen (OA) due to intra-abdominal infection (IAI) are scarce. We hypothesized that patients with IAI managed with OA rather than closed abdomen (CA) would have higher rates of secondary infections (SIs) independent of the duration of the antibiotic treatment. METHODS: This was an observational, prospective, multicenter, international study of patients with IAI requiring laparotomy for source control. Demographic and antibiotic duration values were collected. Primary outcomes were SI (surgical site, bloodstream, pneumonia, urinary tract) and mortality. Statistical analysis included ANOVA, chi-square/Fisher's exact test, and logistic regression. RESULTS: Twenty-one centers contributed 752 patients. The average age was 59.6 years, 43.6% were women, and 43.9% were managed with OA. Overall mortality was 16.1%, with higher rates among OA patients (31.6% vs 4.4%, p < 0.001). OA patients had higher Sequential Organ Failure Assessment (4.7 vs 1.8, p < 0.001), American Society of Anesthesiologists Physical Status (3.6 vs 2.7, p < 0.001), and APACHE II scores (16.1 vs 9.4, p < 0.001). The mean duration of antibiotics was 6.5 days (8.0 OA vs 5.4 CA, p < 0.001). A total of 179 (23.8%) patients developed SI (33.1% OA vs 16.8% CA, p < 0.001). Longer antibiotic duration was associated with increased rates of SI: 1 to 2 days, 15.8%; 3 to 5 days, 20.4%; 6 to 14 days, 26.6%; and more than 14 days, 46.8% (p < 0.001). CONCLUSIONS: Patients with IAI managed with OA had higher rates of SI and increased mortality compared with CA. A prolonged duration of antibiotics was associated with increased rates of SI. Increased antibiotic duration is not associated with improved outcomes in patients with IAI and OA.

A core outcome set for damage control laparotomy via modified Delphi method.

OBJECTIVES: Damage control laparotomy (DCL) remains an important tool in the trauma surgeon's armamentarium. Inconsistency in reporting standards have hindered careful scrutiny of DCL outcomes. We sought to develop a core outcome set (COS) for DCL clinical studies to facilitate future pooling of data via meta-analysis and Bayesian statistics while minimizing reporting bias. METHODS: A modified Delphi study was performed using DCL content experts identified through Eastern Association for the Surgery of Trauma (EAST) 'landmark' DCL papers and EAST ad hoc COS task force consensus. RESULTS: Of 28 content experts identified, 20 (71%) participated in round 1, 20/20 (100%) in round 2, and 19/20 (95%) in round 3. Round 1 identified 36 potential COS. Round 2 achieved consensus on 10 core outcomes: mortality, 30-day mortality, fascial closure, days to fascial closure, abdominal complications, major complications requiring reoperation or unplanned re-exploration following closure, gastrointestinal anastomotic leak, secondary intra-abdominal sepsis (including anastomotic leak), enterocutaneous fistula, and 12-month functional outcome. Despite feedback provided between rounds, round 3 achieved no further consensus. CONCLUSIONS: Through an electronic survey-based consensus method, content experts agreed on a core outcome set for damage control laparotomy, which is recommended for future trials in DCL clinical research. Further work is necessary to delineate specific tools and methods for measuring specific outcomes. LEVEL OF EVIDENCE: V, criteria.

Surgical Infection Society Guidelines for Total Abdominal Colectomy versus Diverting Loop Ileostomy with Antegrade Intra-Colonic Lavage for the Surgical Management of Severe or Fulminant, Non-Perforated Clostridioides difficile Colitis.

Background: Clostridioides difficile infection (CDI) can result in life-threatening illness requiring surgery. Surgical options for managing severe or fulminant, non-perforated C. difficile colitis include total abdominal colectomy with end ileostomy or creation of a diverting loop ileostomy with antegrade vancomycin lavage. Methods: The Surgical Infection Society's Therapeutics and Guidelines Committee convened to develop guidelines for summarizing the current SIS recommendations for total abdominal colectomy versus diverting loop ileostomy with antegrade lavage for severe or fulminant, non-perforated C. difficile colitis. PubMed, Embase, and the Cochrane database were searched for pertinent studies. Severe infection was defined as laboratory diagnosis of C. difficile infection with leukocytosis (white blood cell count of ≥15,000 cells/mL) or elevated creatinine (serum creatinine level >1.5 mg/dL). Fulminant infection was defined as laboratory diagnosis of C. difficile infection with hypotension or shock, ileus, or megacolon. Perforation was defined as complete disruption of the colon wall. Total abdominal colectomy was defined as resection of the ascending, transverse, descending, and sigmoid colon with end ileostomy. For the purpose of the guideline, the terms subtotal colectomy, total abdominal colectomy, and rectal-sparing total colectomy were used interchangeably. Diverting loop ileostomy with antegrade enema was defined as creation of both a diverting loop ileostomy with intra-operative colonic lavage and post-operative antegrade vancomycin unless otherwise specified. Evaluation of the published evidence was performed using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. Using a process of iterative consensus, all committee members voted to accept or reject each recommendation. Results: We recommend that total abdominal colectomy be the procedure of choice for definitive therapy of severe or fulminant, non-perforated C. difficile colitis. In select patients, colon preservation using diverting loop ileostomy with intra-colonic vancomycin may be associated with higher rates of ostomy reversal and restoration of gastrointestinal continuity but may lead to development of recurrent C. difficile colitis. Conclusions: This guideline summarizes the current Surgical Infection Society recommendations regarding use of total abdominal colectomy versus diverting loop ileostomy with antegrade lavage for adults with severe or fulminant, non-perforated C. difficile infection.

Emergency General Surgery Procedures and Cost of Care for Older Adults in the State of Maryland.

BACKGROUND: Older adults (OAs) ≥ 65 years of age, representing the fastest growing segment in the United States, are anticipated to require a greater percentage of emergency general surgery procedures (EGSPs) with an associated increase in health care costs. The aims of this study were to identify the frequency of EGSP and charges incurred by OA compared to their younger counterparts in the state of Maryland. METHODS: A retrospective review of the Maryland Health Services Cost Review Commission from 2009 to 2018 was undertaken. Patients undergoing urgent or emergent ESGP were divided into 2 groups (18-64 years and ≥65 years). Data collected included demographics, APR-severity of illness (SOI), APR-risk of mortality (ROM), the EGSP (partial colectomy [PC], small bowel resection [SBR], cholecystectomy, operative management of peptic ulcer disease, lysis of adhesions, appendectomy, and laparotomy), length of stay (LOS), and hospital charges. P-values (P < .05) were significant. RESULTS: Of the 181,283 patients included in the study, 55,401 (38.1%) were ≥65 years of age. Older adults presented with greater APR-SOI (major 37.7% vs 21.3%, extreme 5.2% vs 9.3%), greater APR-ROM (major 25.3% vs 8.7%, extreme 22.3% vs 5.3%), underwent PC (24.5% vs 10.9%) and SBR (12.8% vs 7.0%) more frequently, and incurred significantly higher median hospital charges for every EGSP, consistently between 2009 and 2018 due to increased LOS and complications when compared to those ≤65 years of age. CONCLUSION: These findings stress the need for validated frailty indices and quality improvement initiatives focused on the care of OAs in emergency general surgery to maximize outcomes and optimize cost.

Dementia and the Critically Ill Older Adult.

Dementia is a terminal illness that leads to progressive cognitive and functional decline. As the elderly population grows, the incidence of dementia in hospitalized older adults increases and is associated with poor short-term and long-term outcomes. Delirium is associated with an accelerated cognitive decline in hospitalized patients with dementia. The first step in the management of dementia is accurate and early diagnosis. Evidence-based management guidelines in the setting of critical illness and dementia are lacking. The cornerstone of management is defining goals of care early in the course of hospitalization and using palliative care and hospice when deemed appropriate.

Characteristics and Outcomes of Drainage Versus Surgery First in Severe Pancreatitis.

BACKGROUND: Percutaneous drainage as the initial procedure for severe pancreatitis (SP) may not always be optimal. Our aim was to identify the characteristics of patients who failed percutaneous drainage and compare their outcomes with patients who underwent surgical intervention as the initial approach. METHODS: A retrospective review of a prospectively collected emergency general surgery registry of patients admitted to a tertiary-care, academic center with the diagnosis of SP who underwent an intervention was performed (2010-2018). Patients were divided into successful drainage (SD), drainage failure (DF), and surgery first (SF) groups. DF was defined as the need for surgical intervention. RESULTS: The study included 129 patients. Fifty (38.8%) patients underwent SF as their initial management modality. Among 79 patients who underwent drainage, 34 (43.0%) were in the DF group and progressed to surgical intervention. Within that group, 19 (55.9%) underwent open necrosectomy. The DF group was more likely to have lower rates of peripancreatic fluid collections, a higher rate of necrotizing pancreatitis, and a higher Acute Physiology and Chronic Health Evaluation (APACHE) II score when compared with the DS group. Mortality was higher in the DF and SF groups, and total length of stay and ICU length of stay were highest in the DF group. DISCUSSION: Patients who experience failure of drainage for SP have high morbidity and mortality rates and fare worse overall than patients who undergo surgery as the primary intervention. Patients with necrotizing pancreatitis and a higher APACHE II score might warrant surgical intervention over a drainage-first approach.

Resuscitative Endovascular Balloon Occlusion of Aaorta Use in Nontrauma Emergency General Surgery: A Multi-institutional Experience.

BACKGROUND: The aim of this study was to determine the current utilization patterns of resuscitative endovascular balloon occlusion of aorta (REBOA) for hemorrhage control in nontrauma patients. METHODS: Data on REBOA use in nontrauma emergency general surgery patients from six centers, 2014-2019, was pooled for analysis. We performed descriptive analyses using Fisher's exact, Student's t, chi-squared, or Mann-Whitney U tests as appropriate. RESULTS: Thirty-seven patients with acute hemorrhage from nontrauma sources were identified. REBOA placement was primarily performed by trauma attendings (20/37, 54%) and vascular attendings (13/37, 35%). In seven patients (19%), balloons were positioned prophylactically but never inflated. In 24 (65%) of 37 patients, REBOA was placed in the operating room. 28/37 balloons (76%) were advanced to zone 1, 8/37 (22%) were advanced to zone 3, and there was one REBOA use in the inferior vena cava. Most common indications were gastrointestinal and peripartum bleeding. In the 30 cases of balloon inflation, 24 of 30 (80%) resulted in improved hemodynamics. Eleven of 30 patients (37%) died before discharge. One patient developed a distal embolism, but there were no reports of limb loss. Twelve patients (40% of all REBOA inflations and 63% of survivors) were discharged to home. CONCLUSIONS: REBOA has been used in a range of acutely hemorrhaging emergency general surgery patients with low rates of access-related complications. Mortality is high in this patient population and further research is needed; however, appropriate patient selection and early use may improve survival in these life-threatening cases.

Prospective validation of the Emergency Surgery Score in emergency general surgery: An Eastern Association for the Surgery of Trauma multicenter study.

BACKGROUND: The Emergency Surgery Score (ESS) was recently developed and retrospectively validated as an accurate mortality risk calculator for emergency general surgery. We sought to prospectively validate ESS, specifically in the high-risk nontrauma emergency laparotomy (EL) patient. METHODS: This is an Eastern Association for the Surgery of Trauma multicenter prospective observational study. Between April 2018 and June 2019, 19 centers enrolled all adults (aged >18 years) undergoing EL. Preoperative, intraoperative, and postoperative variables were prospectively and systematically collected. Emergency Surgery Score was calculated for each patient and validated using c-statistic methodology by correlating it with three postoperative outcomes: (1) 30-day mortality, (2) 30-day complications (e.g., respiratory/renal failure, infection), and (3) postoperative intensive care unit (ICU) admission. RESULTS: A total of 1,649 patients were included. The mean age was 60.5 years, 50.3% were female, and 71.4% were white. The mean ESS was 6, and the most common indication for EL was hollow viscus perforation. The 30-day mortality and complication rates were 14.8% and 53.3%; 57.0% of patients required ICU admission. Emergency Surgery Score gradually and accurately predicted 30-day mortality; 3.5%, 50.0%, and 85.7% of patients with ESS of 3, 12, and 17 died after surgery, respectively, with a c-statistic of 0.84. Similarly, ESS gradually and accurately predicted complications; 21.0%, 57.1%, and 88.9% of patients with ESS of 1, 6, and 13 developed postoperative complications, with a c-statistic of 0.74. Emergency Surgery Score also accurately predicted which patients required intensive care unit admission (c-statistic, 0.80). CONCLUSION: This is the first prospective multicenter study to validate ESS as an accurate predictor of outcome in the EL patient. Emergency Surgery Score can prove useful for (1) perioperative patient and family counseling, (2) triaging patients to the intensive care unit, and (3) benchmarking the quality of emergency general surgery care. LEVEL OF EVIDENCE: Prognostic study, level III.

Correction to: Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

[This corrects the article DOI: 10.1186/s13017-019-0259-9.].

Evaluation of a water-soluble contrast protocol for small bowel obstruction: A southwestern surgical congress multicenter trial.

Differentiation between SBO that will resolve with supportive measures and those requiring surgery remains challenging. WSC administration may be diagnostic and therapeutic. The purpose of this study was to evaluate use of a SBO protocol using WSC challenge. A protocol was implemented at five tertiary care centers. Demographics, prior surgical history, time to operation, complications, and LOS were analyzed. 283 patients were admitted with SBO; 13% underwent immediate laparotomy; these patients had a median LOS of 7.5 days. The remaining 245 were candidates for WSC challenge. Of those, 80% received contrast. 139 (71%) had contrast passage to the colon. LOS in these patients was 4 days. Sixty-five patients (29%) failed contrast passage within 24 h and underwent surgery. LOS was 9 days. 8% of patients in whom contrast passage was observed at 24 h nevertheless subsequently underwent surgery. 4% of patients who failed WSC challenge did not proceed to surgery. Our multicenter trial revealed that implementation of a WSC protocol may facilitate early recognition of partial from complete obstruction.

Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

Background: Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study (https://clinicaltrials.gov/ct2/show/NCT03163095) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body: Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions: A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.

Interhospital Transfers with Wide Variability in Emergency General Surgery.

Interhospital transfer of emergency general surgery (EGS) patients is a common occurrence. Modern individual hospital practices for interhospital transfers have unknown variability. A retrospective review of the Maryland Health Services Cost Review Commission database was undertaken from 2013 to 2015. EGS encounters were divided into three groups: encounters not transferred, encounters transferred from a hospital, and encounters transferred to a hospital. In total, 380,405 EGS encounters were identified, including 12,153 (3.2%) encounters transferred to a hospital, 10,163 (2.7%) encounters transferred from a hospital, and 358,089 (94.1%) encounters not transferred. For individual hospitals, percentage of encounters transferred to a hospital ranged from 0 to 30.05 per cent, encounters transferred from a hospital from 0.02 to 14.62 per cent, and encounters not transferred from 69.25 to 99.95 per cent of total encounters at individual hospitals. Percentage of encounters transferred from individual hospitals was inversely correlated with annual EGS hospital volume (P < 0.001, r = -0.59), whereas percentage of encounters transferred to individual hospitals was directly correlated with annual EGS hospital volume (P < 0.001, r = 0.51). Individual hospital practices for interhospital transfer of EGS patients have substantial variability. This is the first study to describe individual hospital interhospital transfer practices for EGS.