Appendicitis

This prospective, multicentre, global cohort study will capture patients within an overall study window of 3 February 2025 to 25 May 2025. Any hospital performing appendicectomy worldwide will be eligible to participate, collecting data over 14 days for consecutive patients undergoing appendicectomy for suspected or confirmed acute appendicitis. The primary aim is to identify areas for system strengthening in emergency surgery using appendicitis as a tracer condition with a pre-defined key performance measurement set. The secondary aims of this study are to evaluate variations in the presentation, diagnosis, management, access to minimally invasive surgery, and outcomes of patients that have surgery for suspected acute appendicitis. Variation could be assessed across groups stratified by human development index, hospital funding, urban/rural, and facility level. All consecutive patients undergoing appendicectomy for suspected or confirmed appendicitis are eligible for inclusion and should be captured in the study. No additional follow-up is required for this study. Follow-up data will be collected from routine health records. Based on previous NIHR-GSU prospective cohort studies, this study is anticipated to include around 500 hospitals. Based on an average of one appendectomy per day and two 14-day data collection blocks per hospital, we anticipate capturing data for 14,000 patients.

Trauma is a leading cause of death in children in the US. Abdominal trauma accounts for 30% of all pediatric traumatic deaths, second only to traumatic brain injury. Although CT is the reference standard for diagnosing intra-abdominal injury, it is associated with ionizing radiation, inducing malignancies at an estimated rate of 1 per 500 abdominal CT scans in children \<5 years and 1 per 600 scans in adolescents. Thus, CT use should be limited to those at non-negligible risk of intra-abdominal injury. The Focused Assessment with Sonography for Trauma (FAST) examination has also evolved as a diagnostic test for the evaluation for intra-abdominal injury; however, it is used primarily in adults. The FAST examination uses abdominal ultrasonography to detect the presence of intraperitoneal fluid in injured patients. If intraperitoneal fluid is identified following a traumatic injury, this fluid is presumed to be blood (hemoperitoneum). The FAST examination for detection of hemoperitoneum in trauma consists of several images. These include a right hepatorenal interface (Morison's pouch), perisplenic view, and longitudinal and transverse views of the pelvis. Potential advantages of initial ED evaluation of the injured child using the FAST examination include: 1) bedside evaluation during initial patient ED evaluation and resuscitation; 2) rapid completion of the diagnostic test (within 3-5 minutes); 3) performance of the test and interpretation of results by ED physicians or trauma surgeons caring for the child; 4) no radiation exposure; and 5) reduced patient-care costs compared to routine use of abdominal CT. In adults, a positive FAST examination is the best predictor of intra-abdominal injury. In two adult randomized controlled trials, the use of FAST demonstrated improved patient care by decreasing abdominal CT use, complications and costs. Although the sensitivity of the FAST exam for intra-abdominal injury is lower than CT, as a screening test, it may decrease the need for abdominal CT in both low risk injured adults and children. The long-term objective of this research study is to determine appropriate evaluation strategies to optimize the care of injured children, leading to improved quality of care and a reduction in morbidity and mortality. The specific aims of this proposal are to: 1) perform a randomized, controlled trial of the FAST examination in injured children and compare the frequency of abdominal CT scanning between children who are randomized to the FAST and non-FAST arms; 2) identify if an evaluation strategy including the FAST examination results in a similar frequency of missed or delayed diagnoses of intra-abdominal injuries than a strategy without the FAST examination; and 3) identify patient, physician, and system factors associated with obtaining abdominal CT scans in patients considered low risk for intra-abdominal injuries by the clinician after a negative FAST examination. Such a study has the potential for significant impact in improving the lives of injured children, if found to be successful. This randomized controlled trial will follow the methods of the one prior randomized controlled trial of FAST in injured children which enrolled 925 injured children at a single center. This study incorporate a total of six centers to increase the sample size and generalizability of the results.

The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD

The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.

Background: China's healthcare system for children faces significant challenges, particularly due to the limited pediatric service capacity of primary healthcare institutions. A shortage of effective and accessible training tools for primary care doctors further hinders progress in addressing this gap. Technological advancements, especially in artificial intelligence, offer a potential solution to improve pediatric care. Artificial intelligence-driven virtual standardized patients (VSPs), leveraging internet and virtual simulation technologies, simulate clinical cases with specific disease characteristics, providing an innovative, efficient, and flexible training method. VSPs are increasingly utilized in medical education, clinical reasoning, and licensure exams. This study focuses on using VSPs to improve the management of common pediatric conditions, which are major health concerns for children and impose significant psychological and financial burdens on families. Methods: This study will involve a three-arm randomized controlled trial to evaluate the effectiveness of a virtual pediatric standardized patient platform in enhancing primary care doctors' management of common pediatric diseases. At least 459 participants, including general practitioners, internal medicine practitioners, surgeons, and pediatricians from more than 10 provinces across China, will be randomly assigned to one of three groups: the virtual patient platform group, the case teaching manual group, or the case teaching video group. Five virtual patient cases covering pneumococcal pneumonia, rotavirus enteritis with hypovolemic shock, hand-foot-and-mouth disease, acute appendicitis, and respiratory failure will be developed, along with corresponding case teaching materials. After a two-week learning period, participants' disease management abilities will be assessed using clinical vignettes. The primary outcome is adherence to best clinical practice guidelines, categorized into full adherence, partial adherence, and nonadherence. Discussion: This study aims to leverage artificial intelligence for capacity enhancement, targeting the shortcomings of primary care pediatrics and using VSP to help enhance primary care pediatrics capacity. It is a randomized controlled trial involving over 300 primary healthcare institutions across more than 10 provinces in China, ensuring broad and representative participation from both developed and underdeveloped regions.

The goal of this observational cohort study is to evaluate the standard of care for general surgerical patients undergoing emergency laparotomy and assess factors affecting clinical outcomes, as well as evaluating the quality of life in the year after abdominal surgery. The main questions it aims to answer are: 1. what factors are associated with adverse post-operative events 2. are patients treated differently based on sex or age 3. how does quality of life look like and possibly change over the coarse of a year after surgery This is an evaluation of the current standard of care and the outcomes of this patient group prior to the implementation of a standardised care protocols for emergency laparotomy patients. Secondly, the study aims to, over time, compare results before and after the introduction of this standardised care protocol.

The human gut microbiota constitutes one of the densest microbial communities on Earth, encompassing a highly diverse assembly of microorganisms that perform metabolic, immune, and protective functions crucial to human health. The gastrointestinal microbiota is influenced by a variety of factors, including genetics, host physiological status (such as age, disease, and stress), and environmental conditions such as living environment and medication use. Among these numerous perturbing factors, iatrogenic interventions-particularly the bowel cleansing procedure essential before colonoscopy-exert a particularly significant impact on the gut microecosystem. Current colonoscopy preparation involves the administration of large volumes of polyethylene glycol (PEG2000-4000) as a laxative and lubricant. Existing studies indicate that PEG use may markedly reduce microbial richness and diversity. Specifically, PEG ingestion can lead to aberrant proliferation of \*Akkermansia\* species, a reduction in Firmicutes, and an increased load and virulence gene expression of pathogens such as \*Citrobacter\*. Metabolically, PEG use may result in decreased dehydroxylation of primary bile acids and altered cholesterol metabolism, ultimately contributing to diarrhea, weight loss, disruption of lipid and energy metabolism, and intestinal inflammation. Thus, extensive use of PEG may cause long-term and irreversible damage to the gut microbiota, posing substantial risks to health. The appendix, located at the base of the cecum, is an elongated, tubular structure protruding from the posterior wall of the cecum. As an integral component of the intestinal mucosal immune system, its lumen harbors rich biofilm structures that provide an "ecological sanctuary" for commensal bacteria, shielding them from the flushing effect of intestinal contents. Emerging research indicates that under physiological conditions, the appendix continuously receives and shelters specific microbiota from the proximal colon, particularly adherent members of the Firmicutes and Bacteroidetes phyla. When microbial dysbiosis occurs in the host-due to factors such as infection, antibiotic exposure, or bowel cleansing-the appendix can serve as a microbial reservoir, accelerating the process of microecological restoration. Therefore, the appendix is considered a "natural backup system" for the gut microbiota, and its integrity plays an irreplaceable role in resisting microbial disturbances and maintaining microecological resilience. Historically, appendicitis has ranked as the most common acute abdominal emergency, and once acute appendicitis occurs, traditional therapy often involves appendectomy. Extensive epidemiological evidence has shown that post-appendectomy populations have significantly elevated risks of \*Clostridioides difficile\* infection, colorectal cancer, Parkinson's disease, and depression. Metagenomic studies further reveal that appendectomized individuals exhibit reduced gut microbial diversity, persistently low abundance of short-chain fatty acid-producing genera (e.g., \*Faecalibacterium\* and \*Roseburia\*), diminished stability of microbial networks, and compromised resistance and resilience against external disturbances. These findings suggest that appendiceal loss may place the gut microecosystem in a state of "fragile equilibrium," wherein superimposing the strong perturbation of PEG-based bowel cleansing could induce more severe and persistent dysbiosis. This study adopts a parallel-controlled, monitored clinical trial design, enrolling a total of approximately 10 participants. Eligible subjects must have previously undergone appendectomy or right hemicolectomy with appendectomy, be aged 18-75 years, be scheduled for colonoscopy, be generally healthy, and have no history of major organ diseases. Control subjects must be aged 18-75 years, have no history of appendectomy or right hemicolectomy with appendectomy, be generally healthy, and have no history of major organ diseases. Both groups must meet corresponding exclusion criteria, including: contraindications to colonoscopy (e.g., organic diseases such as cardiopulmonary insufficiency), inability to tolerate PEG laxatives, pregnancy, long-standing history of intestinal diseases, or antibiotic use within the past six months. Fecal samples will be collected at multiple time points: before colonoscopy, at the first non-watery stool after colonoscopy, and at one month, three months, and six months post-colonoscopy. Metagenomic sequencing will be used to detect fecal gut microbial information, and bioinformatics analysis will be performed with a focus on: (1) the long-term effects of colonoscopy on the gut microbiota and the disturbance characteristics during gut microecological recovery following appendectomy; (2) designing microecological restoration probiotic formulations based on microbiome features; and (3) screening representative fecal samples for subsequent animal experiments. This study will not use recruitment advertisements; participation is entirely voluntary. Subjects will be informed of potential risks during the experiment and will sign informed consent forms upon agreeing to join the study. Volunteers who consent to participate will complete a questionnaire to assess their intestinal health status and other health conditions and will be screened according to the aforementioned selection and exclusion criteria. Collected samples will be labeled with codes to ensure that no personally identifiable information is disclosed. Throughout the study, participants' identities will be kept confidential, with only codes and disease phenotypes visible. Subjects may withdraw from the study at any time. This study will analyze the composition and structure of participants' gut microbiota, and subjects will be kept informed of the progress of the tests and analyses in a timely manner and will have access to their own relevant data.

This is a single-center, prospective observational study conducted in adult patients presenting to the emergency department with suspected acute appendicitis. Patients aged 18 years or older who undergo computed tomography (CT) after clinical evaluation, have a CT report compatible with acute appendicitis, and subsequently undergo appendectomy will be eligible for inclusion. Patients younger than 18 years, pregnant patients or those with suspected pregnancy, patients taken directly to surgery without CT evaluation, patients whose CT report suggests a diagnosis other than acute appendicitis, patients requiring an additional non-appendectomy surgical procedure because of another intraoperative pathology, and patients who decline participation will be excluded. Clinical and demographic data will be collected prospectively using a standardized study form. Recorded variables will include age, sex, comorbidities, previous abdominal surgery history, symptom duration, physical examination findings, and laboratory parameters relevant to appendicitis assessment. The Appendicitis Inflammatory Response (AIR) score will be calculated using routine clinical and laboratory data. CT examinations obtained as part of routine emergency care will be reviewed according to the official radiology reports. Intraoperative findings will be graded using the American Association for the Surgery of Trauma (AAST) appendicitis severity grading system. Final histopathologic examination of the resected appendix specimen will be used as the reference standard. The primary outcome measure is the negative appendectomy rate, defined as appendectomy with final pathology not confirming acute appendicitis. Secondary outcome measures include agreement between AIR score and final pathology, agreement between CT report and final pathology, agreement between intraoperative AAST grading and final pathology, and differences in diagnostic performance across patient subgroups such as age, sex, and previous abdominal surgery history. No study-specific intervention will be applied beyond routine diagnostic and therapeutic management. Treatment decisions will be made according to standard clinical practice. All data will be coded and recorded without directly identifiable patient information.

All patients will be recruited into the study and these patients will be randomized in permuted blocks of 4 to 6 to one of two arms. Each arm will have two treatments which will be given to the patient depending on the case nature: acute or complicated. Comparisons in DOOR outcome will be compared only within the case nature strata by treatment; since the stratification criteria makes comparisons between strata not feasible. In order to attempt to retrieve the expected rates of DOOR outcomes from a Randomized Controlled Trial (RCT) propensity score matching via the MatchIt algorithm was utilized. The issue being mitigated is that our patients were part of an observation where treatment was a byproduct of patient characteristics which would introduce selection into treatment bias and our direct estimates of DOOR outcomes would not be valid for powering an RCT. AAST clinical grade, body mass index, age, Charlson Comorbidity Index (CCI), and prior operations were used in the matching. 1:1 matching was utilized resulting in 479 match pairs from the MUSTANG dataset and diagnostics for matches were explored and it suggested that good matches were obtained. Below are the rates from the matched set, one observation was added to every cell to ensure that there were no zero probabilities in the assumptions. The investigators will recruit patients until a sufficient number of complicated cases to be sufficiently powered for our comparison on treatment within the complicated strata. Since the investigators expect fewer than 50% to be complicated cases, a larger sample size should be available for analysis in the acute (simple) arm. Thus, the clinical trial will be powered for an even larger effect size for simple appendicitis and if a statistically significant difference is not found, it is very likely that if there is a difference it would not be clinically meaningful. Also, since each analysis will depend on a mutually exclusive set of patients, the investigators can consider these to be independent samples for which no adjustment for multiple testing is required. Difference in DOOR score will be tested restrictive versus liberal strategies via proportional odds regression, accounting for enrollment site and age strata. The primary endpoint will be analyzed using an intention-to treat analysis. In case a significant difference is discovered, the investigators plan to calculate the Fragility Index to determine the fragility of the study results. Significance will be determined at an alpha of 0.05. All analyses will be performed in R version 3.6.1 using the clusrank package. Potential subjects will be identified by the clinical team (Acute Care Surgery) during the course of usual clinical care, and the clinical team will inform the subjects about the study and seek their verbal approval to being approached by the study research team. The patient will then be approached by the research team (in the emergency department, pre-operative holding area, or hospital ward) for detailed discussion about the study and for informed consent as outlined in the consent procedures below. If the subject consents to participate and agrees to be randomized, randomization will take place and the subject will be assigned to one of the two study groups (restricted or liberal). If the subject consents to participate but declines to be randomized, we will seek to enroll the patient in an observational arm; the clinician will decide the duration of post-operative antibiotic therapy and data will be collected from the subject's medical records and through a telephone call at approximately 1 month after hospital discharge. It is not possible to obtain consent to participate in this study on another day because if the patient has simple acute appendicitis (80% of cases), they are usually discharged home immediately after surgery or within 12 hours of surgery. For complicated appendicitis patients (20%), the restrictive arm is randomized to only 1 day of post-operative antibiotics and obtaining consent the following day would be too late to assign the subject to this arm. Recruitment will not involve restrictions on socio-demographic factors including gender or ethnic characteristics. Recruitment will be devoid of any procedures which could be constructed as coercive. Study researchers and clinicians will stress that participation is voluntary, that patients are not obliged to participate, and that the decision not to participate in the study will not affect patient care. All subjects will be contacted by telephone at approximately 1 month or later after the index operation and will be assigned to 7 mutually exclusive hierarchical (ie, ordinal) categories in decreasing order of desirability: 1. Cure; no adverse effects 2. Infectious/antibiotic complication requiring antibiotic treatment only only or no specific treatment 3. Infectious/antibiotic complication requiring Emergency Department visit 4. Infectious/antibiotic complication requiring hospital readmission 5. Infectious/antibiotic complication requiring percutaneous drainage 6. Infectious/antibiotic complication requiring operative intervention 7. Death Study subjects will be assigned unique study numbers that will be used in all study documents. No actual names will be used in the study. Only the researchers will know the actual names of the subjects. Study database and documents will be stored in a locked research office at William G Cheadle's office in the ambulatory care building within the Department of Surgery with key access only and will only be accessible to the researchers. A copy of the de-identified data will be stored on REDCap

This is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.