Identifying Indications for Neoadjuvant Therapy in Cholangiocarcinoma.

The recent Hot Topics section focuses on survival rates for patients with cholangiocarcinoma.

Scalability and Sustainability of a Surgical Infection Prevention Program in Low-Income Environments.

Importance: Surgical infections are a major cause of perioperative morbidity and mortality, particularly in low-resource settings. Clean Cut, a 6-month quality improvement program developed by the global nonprofit organization Lifebox, has demonstrated improvements in postoperative infectious complications. However, the pilot program required intense external programmatic and resource support. Objective: To examine the improvement in adherence to infection prevention and control standards and rates of postoperative infections in hospitals in the Clean Cut program after implementation strategies were updated and program execution was refined. Design, Setting, and Participants: This cohort study evaluated and refined the Clean Cut implementation strategy to enhance scalability based on a qualitative study of its pilot phase, including formalizing programmatic and educational materials, building an automated data entry and analysis platform, and reorganizing hospital-based team composition. Clean Cut was introduced from January 1, 2019, to February 28, 2022, in 7 Ethiopian hospitals that had not previously participated in the program. Prospective data initiated on arrival in the operating room were collected, and patients were followed up through hospital discharge and with 30-day follow-up telephone calls. Exposure: Implementation of the refined Clean Cut program. Main Outcomes and Measures: The primary outcome was surgical site infection (SSI); secondary outcomes were adherence to 6 infection prevention standards, mortality, hospital length of stay, and other infectious complications. Results: A total of 3364 patients (mean [SD] age, 26.5 [38.0] years; 2196 [65.3%] female) from 7 Ethiopian hospitals were studied (1575 at baseline and 1789 after intervention). After controlling for confounders, the relative risk of SSIs was reduced by 34.0% after program implementation (relative risk, 0.66; 95% CI, 0.54-0.81; P < .001). Appropriate Surgical Safety Checklist use increased from 16.3% to 43.0% (P < .001), surgeon hand and patient skin antisepsis improved from 46.0% to 66.0% (P < .001), and timely antibiotic administration improved from 17.8% to 39.0% (P < .001). Surgical instrument (38.7% vs 10.2%), linen sterility (35.5% vs 12.8%), and gauze counting (89.2% vs 82.5%; P < .001 for all comparisons) also improved significantly. Conclusions and Relevance: A modified implementation strategy for the Clean Cut program focusing on reduced external resource and programmatic input from Lifebox, structured education and training materials, and wider hospital engagement resulted in outcomes that matched our pilot study, with improved adherence to recognized infection prevention standards resulting in a reduction in SSIs. The demonstration of scalability reinforces the value of this SSI prevention program.

Value and Feasibility of Telephone Follow-Up in Ethiopian Surgical Patients.

Background: Surgical site infections (SSIs) represent a major cause of morbidity and mortality in Ethiopia. Lack of post-discharge follow-up, including identification of SSIs, is a barrier to continued patient care, often because of financial and travel constraints. As part of a surgical quality improvement initiative, we aimed to assess patient outcomes at 30 days post-operative with a telephone call. Patients and Methods: We conducted mobile telephone follow-up as part of Lifebox's ongoing Clean Cut program, which aims to improve compliance with intra-operative infection prevention standards. One urban tertiary referral hospital and one rural district general hospital in Ethiopia were included in this phase of the study; hospital nursing staff called patients at 30 days post-operative inquiring about signs of SSIs, health-care-seeking behavior, and treatments provided if patients had any healthcare encounters since discharge. Results: A total of 701 patients were included; overall 77% of patients were reached by telephone call after discharge. The rural study site reached 362 patients (87%) by telephone; the urban site reached 176 patients (62%) (p < 0.001). Of the 39 SSIs identified, 19 (49%) were captured as outpatient during the telephone follow-up (p < 0.001); 22 (34%) of all complications were captured following discharge (p < 0.001). Telephone follow-up improved from 65%-78% in the first half of project implementation to 77%-89% in the second half of project implementation. Conclusion: Telephone follow-up after surgery in Ethiopia is feasible and valuable, and identified nearly half of all SSIs and one-third of total complications in our cohort. Follow-up improved over the course of the program, likely indicating a learning curve that, once overcome, is a more accurate marker of its practicability. Given the increasing use of mobile telephones in Ethiopia and ease of implementation, this model could be practical in other low-resource surgical settings.

Qualitative outcomes of Clean Cut: implementation lessons from reducing surgical infections in Ethiopia.

BACKGROUND: Clean Cut is a six month, multi-modal, adaptive intervention aimed at reducing surgical infections through improving six critical perioperative processes: 1) handwashing/skin preparation, 2) surgical gown/drape integrity, 3) antibiotic administration, 4) instrument sterility, 5) gauze counts, and 6) WHO Surgical Safety Checklist use. The aim of this study was to elucidate themes across Clean Cut implementation sites in Ethiopia to improve implementation at future hospitals. METHODS: We conducted semi-structured interviews of 20 clinicians involved in Clean Cut at four hospitals. Participation was limited to Clean Cut team members and included surgeons, anesthetists, operating room (OR) nurses, ward nurses, OR managers, quality improvement personnel, and hospital administrators. Audio recordings were transcribed and coded using qualitative software. A codebook was inductively and iteratively derived between two researchers, tested for inter-rater reliability, and applied to all transcripts. We conducted thematic analysis to derive our final qualitative results. RESULTS: The interviews revealed barriers and facilitators to the implementation of Clean Cut, as well as strategies for future implementation sites. Key barriers included material resource limitations, feelings of job burden, existing gaps in infection prevention education, and communication errors during data collection. Common facilitators included strong hospital leadership support, commitment to improved patient outcomes, and organized Clean Cut training sessions. Future strategies include resource assessments, creating a sense of responsibility among staff, targeted training sessions, and incorporating new standards into daily routine. CONCLUSIONS: The findings of this study highlight the importance of engaging hospital leadership, providers and staff in quality improvement programs, and understanding their work contexts. The identified barriers and facilitators will inform future initiatives in the field of perioperative infection prevention.

Tactics to Prevent Intra-Abdominal Infections in General Surgery.

BACKGROUND: Abdominal infections following surgery have many severe consequences. Several effective, well-evaluated infection prevention and control processes exist to avoid these infections. METHODS: This manuscript reviews and provides supporting evidence for common management strategies useful to avoid postoperative abdominal infection. RESULTS: Prevention of abdominal infection begins with preparation of the environment using standard infection control practices. Peri-operative use of systemic antibiotics, an antibiotic bowel preparation in colorectal surgery, and effective antiseptic preparation of the surgical site all reduce infection rates. Peri-operative supplemental oxygenation, maintenance of core body temperature, and physiologic euglycemia will reduce both incisional and organ-space infections in the abdominal surgery patient. Strategic use of irrigation and drain placement may be useful in some circumstances. CONCLUSION: Specific methods of prevention are documented to reduce intra-abdominal infections. Prevention requires a multi-disciplinary team including the surgeon, anesthesiologist, and all operating room personnel.

Estimating the Incidence of Stray Energy Burns during Laparoscopic Surgery based on Two Statewide Databases and Retrospective Rates: An Opportunity to Improve Patient Safety.

BACKGROUND: The growth of laparoscopic surgery has increased the use of laparoscopic electrosurgical devices based on radiofrequency current. Despite an improvement in most post-operative outcomes, the use of these devices can be associated with inadvertent thermal or mechanical injuries, also called accidental punctures and lacerations (APLs). APLs can occur through either operator error or system error, including insulation failure or capacitive coupling resulting in stray energy burns. Our aim was to estimate the incidence and-as a result-the impact of laparoscopic APLs. METHODS: A retrospective analysis of the Healthcare Cost and Utilization Project (HCUP) State Inpatient Database (SID) was performed for 2009 in California (CA) and Florida (FL). ICD-9 codes and current procedural terminology were used to query for five common general surgery procedures: appendectomy, cholecystectomy, fundoplication, gastric bypass, and gastroplasty with these procedures cross-referenced for any secondary procedure at the time of the initial surgery indicative of APLs. The c2 test was used for comparisons where appropriate. RESULTS: Overall, 192,794 primary laparoscopic procedures were identified in the HCUP database in CA and FL in 2009, with a similar procedure frequency distribution between CA and FL. Six hundred ninety-four procedures were complicated by APL. Gastric bypass and fundoplication were more commonly associated with APLs. CONCLUSION: In this retrospective analysis of procedures performed in CA and FL, the estimated incidence of APL was 3.6 per 1000 cases. Patient morbidity and mortality were likely related to both pilot-error injuries and stray energy burns during laparoscopy. Possible solutions to reduce surgical complications from APL include educational programs to reduce pilot error and the incorporation of fail-safe technologies to eliminate stray energy burns, such as active electrode monitoring and use of non-radiofrequency current (true cautery).

Surgical Instrument Reprocessing in Resource-Constrained Countries: A Scoping Review of Existing Methods, Policies, and Barriers.

BACKGROUND: Surgical infections are a major cause of morbidity and mortality in low- and middle-income countries (LMICs). Inadequately reprocessed surgical instruments can be a vector for pathogens. Little has been published on the current state of surgical instrument reprocessing in LMICs. METHODS: We performed a scoping review of English-language articles in PubMed, Web of Science, and Google Scholar databases describing current methods, policies, and barriers to surgical instrument reprocessing in LMICs. We conducted qualitative analysis of all studies to categorize existing practices and barriers to successful surgical instrument reprocessing. Barriers were non-exclusively categorized by theme: training/education, resource availability, environment, and policies/procedures. Studies associating surgical infections with existing practices were separately evaluated to assess this relationship. RESULTS: Nine hundred seventy-two abstracts were identified. Forty studies met criteria for qualitative analysis and three studies associated patient outcomes with surgical instrument reprocessing. Most studies (n = 28, 70%) discussed institution-specific policies/procedures; half discussed shortcomings in staff training. Sterilization (n = 38, 95%), verification of sterilization (n = 19, 48%), and instrument cleaning and decontamination (n = 16, 40%) were the most common instrument reprocessing practices examined. Poor resource availability and the lack of effective education/training and appropriate policies/procedures were cited as the common barriers. Of the case series investigating surgical instrument reprocessing with patient outcomes, improperly cleaned and sterilized neurosurgical instruments and contaminated rinse water were linked to Pseudomonas aeruginosa ventriculitis and Mycobacterium port site infections, respectively. CONCLUSIONS: Large gaps exist between instrument reprocessing practices in LMICs and recommended policies/procedures. Identified areas for improvement include instrument cleaning and decontamination, sterilization aspects of instrument reprocessing, and verification of sterilization. Education and training of staff responsible for reprocessing instruments and realistic, defined policies and procedures are critical, and lend themselves to improvement interventions.

Developing Process Maps as a Tool for a Surgical Infection Prevention Quality Improvement Initiative in Resource-Constrained Settings.

BACKGROUND: Surgical infections cause substantial morbidity and mortality in low-and middle-income countries (LMICs). To improve adherence to critical perioperative infection prevention standards, we developed Clean Cut, a checklist-based quality improvement program to improve compliance with best practices. We hypothesized that process mapping infection prevention activities can help clinicians identify strategies for improving surgical safety. STUDY DESIGN: We introduced Clean Cut at a tertiary hospital in Ethiopia. Infection prevention standards included skin antisepsis, ensuring a sterile field, instrument decontamination/sterilization, prophylactic antibiotic administration, routine swab/gauze counting, and use of a surgical safety checklist. Processes were mapped by a visiting surgical fellow and local operating theater staff to facilitate the development of contextually relevant solutions; processes were reassessed for improvements. RESULTS: Process mapping helped identify barriers to using alcohol-based hand solution due to skin irritation, inconsistent administration of prophylactic antibiotics due to variable delivery outside of the operating theater, inefficiencies in assuring sterility of surgical instruments through lack of confirmatory measures, and occurrences of retained surgical items through inappropriate guidelines, staffing, and training in proper routine gauze counting. Compliance with most processes improved significantly following organizational changes to align tasks with specific process goals. CONCLUSIONS: Enumerating the steps involved in surgical infection prevention using a process mapping technique helped identify opportunities for improving adherence and plotting contextually relevant solutions, resulting in superior compliance with antiseptic standards. Simplifying these process maps into an adaptable tool could be a powerful strategy for improving safe surgery delivery in LMICs.

An Update on Fatalities Due to Venomous and Nonvenomous Animals in the United States (2008-2015).

INTRODUCTION: To review recent (2008-2015) United States mortality data from deaths caused by nonvenomous and venomous animals and compare with historical data. METHODS: The Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database was queried to return all animal-related fatalities between 2008 and 2015. Mortality frequencies for animal-related fatalities were calculated using the estimated 2011 United States population. Inclusion criteria included all mortalities that were a consequence of bite, contact, attack, or envenomation (International Classification of Diseases 10th revision codes W53-W59 and X20-X29). RESULTS: There were 1610 animal-related fatalities, with the majority from nonvenomous animals (4.8 deaths per 10 million persons annually). The largest proportion of animal-related fatalities was due to "other mammals," largely composed of horses and cattle. Deaths attributable to Hymenoptera (hornets, wasps, and bees) account for 29.7% of the overall animal-related fatalities and have been steady over the last 20 years. Dog-related fatality frequencies are stable, although the fatality frequency of 4.6 deaths per 10 million persons among children 4 years of age or younger was nearly 4-fold greater than in the other age groups. CONCLUSIONS: Appropriate education and prevention measures aimed at decreasing injury from animals should be directed at the high-risk groups of agricultural workers and young children with dogs. Public policy and treatment pricing should align to ensure adequate available medication for those at risk of anaphylaxis from stings from Hymenoptera.

Mortality, hospital admission, and healthcare cost due to injury from venomous and non-venomous animal encounters in the USA: 5-year analysis of the National Emergency Department Sample.

BACKGROUND: Injuries due to encounters with animals can be serious, but are often discussed anecdotally or only for isolated types of encounters. We sought to characterize animal-related injuries presenting to US emergency departments (ED) to determine the impact of these types of injuries. METHODS: All ED encounters with diagnosis codes corresponding to animal-related injury were identified using ICD-9-CM codes from the 2010 2014 National Emergency Department Sample (NEDS). Outcomes assessed included inpatient admission, mortality, and healthcare cost. Survey methodology was applied to univariate and multivariate analyses. Weighted numbers are presented. RESULTS: There were 6 457 534 ED visits resulting from animal-related injuries identified. Bites from non-venomous arthropods (n=2 648 880; 41%), dog bites (n=1 658 295; 26%) and envenomation from hornets, wasps or bees (n=812 357; 13%) constitute the majority of encounters. There were 210 516 patients (3%) admitted as inpatients. Inpatient admission was most common for those suffering from venomous snakes or lizard bites (24%, n=10 332). Death was infrequent occurring in 1162 patients (0.02% of all ED presentations). The greatest number of deaths was due to bites from non-venomous arthropods (24% of deaths, n=278) whereas rat bites proved the most lethal (6.5 deaths per 10 000 bites). Among persons aged 85 years or greater, odds of hospital admission for any animal-related injury was 6.42 (95% CI 5.57 to 7.40) and the OR for death was 27.71 (95% CI 10.38 to 73.99). Female sex was associated with improved survival (OR 0.55, 95% CI 0.41 to 0.73) and lower rates of hospital admission (OR 0.77, 95% CI 0.75 to 0.79). The total healthcare cost for these animal encounters during the observed time period was $5.96 billion (95% CI $5.43 to $6.50 billion). CONCLUSION: The morbidity, mortality, and healthcare cost due to animal encounters in the USA is considerable. Often overlooked, this particular mechanism of injury warrants further public health prevention efforts. LEVEL OF EVIDENCE: Level IV.

Development of a Surgical Infection Surveillance Program at a Tertiary Hospital in Ethiopia: Lessons Learned from Two Surveillance Strategies.

BACKGROUND: Surgical site infections (SSIs) are a leading cause of post-operative morbidity and mortality. We developed Clean Cut, a surgical infection prevention program, with two goals: (1) Increase adherence to evidence-based peri-operative infection prevention standards and (2) establish sustainable surgical infection surveillance. Here we describe our infection surveillance strategy. PATIENTS AND METHODS: Clean Cut was piloted and evaluated at a 523 bed tertiary hospital in Ethiopia. Infection prevention standards included: (1) Hand and surgical site decontamination; (2) integrity of gowns, drapes, and gloves; (3) instrument sterility; (4) prophylactic antibiotic administration; (5) surgical gauze tracking; and (6) checklist compliance. Primary outcome measure was SSI, with secondary outcomes including other infection, re-operation, and length of stay. We prospectively observed all post-surgical wounds in obstetrics over a 12 day period and separately recorded post-operative complications using chart review. Simultaneously, we reviewed the written hospital charts after patient discharge for all patients whose peri-operative adherence to infection prevention standards was captured. RESULTS: Fifty obstetric patients were followed prospectively with recorded rates of SSI 14%, re-operation 6%, and death 2%. Compared with direct observation, chart review alone had a high loss to follow-up (28%) and decreased capture of infectious complications (SSI [n = 2], endometritis [n = 3], re-operations [n = 2], death [n = 1]); further, documentation inconsistencies failed to capture two complications (SSI [n = 1], mastitis [n = 1]). Concurrently, 137 patients were observed for peri-operative infection prevention standard adherence. Of these, we were able to successfully review 95 (69%) patient charts with recorded rates of SSI 5%, re-operation 1%, and death 1%. CONCLUSION: Patient loss to follow-up and poor documentation of infections underestimated overall infectious complications. Direct, prospective follow-up is possible but requires increased time, clinical skill, and training. For accurate surgical infection surveillance, direct follow-up of patients during hospitalization is essential, because chart review does not accurately reflect post-operative complications.

Using the WHO Surgical Safety Checklist to Direct Perioperative Quality Improvement at a Surgical Hospital in Cambodia: The Importance of Objective Confirmation of Process Completion.

BACKGROUND: The WHO surgical safety checklist (SSC) is known to prevent postoperative complications; however, strategies for effective implementation are unclear. In addition to cultural and organizational barriers faced by high-income countries, resource-constrained settings face scarcity of durable and consumable goods. We used the SSC to better understand barriers to improvement at a trauma hospital in Battambang, Cambodia. METHODS: We introduced the SSC and trained data collectors to observe surgical staff performing the checklist. Members of the research team observed cases and data collection. After 3 months, we modified the data collection tool to focus on infection prevention and elicit more accurate responses. RESULTS: Over 16 months we recorded data on 695 operations (304 cases using the first tool and 391 cases with the modified tool). The first tool identified five items as being in high compliance, which were then excluded from further assessment. Two items-instrument sterility confirmation and sponge counting-were identified as being misinterpreted by the data collectors' tool. These items were reworded to capture objective assessment of task completion. Confirmation of instrument sterility was initially never performed but rectified to >95% compliance; sponge counting and prophylactic antibiotic administration were consistently underperformed. CONCLUSIONS: Staff complied with communication elements of the SSC and quickly adopted process improvements. The wording of our data collection tool affected interpretation of compliance with standards. Material resources are not the primary barrier to checklist implementation in this setting, and future work should focus on clarification of protocols and objective confirmation of tasks.

Impact of Surgical Lighting on Intraoperative Safety in Low-Resource Settings: A Cross-Sectional Survey of Surgical Providers.

BACKGROUND: Safe surgery requires high-quality, reliable lighting of the surgical field. Little is reported on the quality or potential safety impact of surgical lighting in low-resource settings, where power failures are common and equipment and resources are limited. METHODS: Members of the Lifebox Foundation created a novel, non-mandatory, 18-item survey tool using an iterative process. This was distributed to surgical providers practicing in low-resource settings through surgical societies and mailing lists. RESULTS: We received 100 complete responses, representing a range of surgical centres from 39 countries. Poor-quality surgical field lighting was reported by 40% of respondents, with 32% reporting delayed or cancelled operations due to poor lighting and 48% reporting electrical power failures at least once per week. Eighty per cent reported the quality of their surgical lighting presents a patient safety risk with 18% having direct experience of poor-quality lighting leading to negative patient outcomes. When power outages occur, 58% of surgeons rely on a backup generator and 29% operate by mobile phone light. Only 9% of respondents regularly use a surgical headlight, with the most common barriers reported as unaffordability and poor in-country suppliers. CONCLUSIONS: In our survey of surgeons working in low-resource settings, a majority report poor surgical lighting as a major risk to patient safety and nearly one-third report delayed or cancelled operations due to poor lighting. Developing and distributing robust, affordable, high-quality surgical headlights could provide an ideal solution to this significant surgical safety issue.

Sex disparities among persons receiving operative care during armed conflicts.

BACKGROUND: Armed conflict increasingly involves civilian populations, and health care needs may be immense. We hypothesized that sex disparities may exist among persons receiving operative care in conflict zones and sought to describe predictors of disparity. METHODS: We performed a retrospective analysis of operative interventions performed between 2008 and 2014 at Médecins Sans Frontières Operation Center Brussels conflict projects. A Médecins Sans Frontières Operation Center Brussels conflict project was defined as a program established in response to human conflict, war, or social unrest. Intervention- and country-level variables were evaluated. For multivariate analysis, multilevel mixed-effects logistic regression was used with random-effect modeling to account for clustering and population differences in conflict zones. RESULTS: Between 2008 and 2014, 49,715 interventions were performed in conflict zones by Médecins Sans Frontières Operation Center Brussels. Median patient age was 24 years (range: 1-105 years), and 34,436 (69%) were men. Patient-level variables associated with decreased interventions on women included: American Society of Anesthesiologists score (P = .003), degree of urgency (P = .02), mechanism (P < .0001), and a country's predominant religion (P = .006). Men were 1.7 times more likely to have an operative intervention in a predominantly Muslim country (P = .006). CONCLUSION: Conflict is an unfortunate consequence of humanity in a world with limited resources. For most operative interventions performed in conflict zones, men were more commonly represented. Predominant religion was the greatest predictor of increased disparity between sexes, irrespective of the number of patients presenting as a result of traumatic injury. It is critical to understand what factors may underlie this disparity to ensure equitable and appropriate care for all patients in an already tragic situation.