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Appendicitis clinical trials

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NCT ID: NCT05887414 Recruiting - Appendicitis Clinical Trials

TRIAD Appendicitis Decision-making Surveys

TRIAD
Start date: October 1, 2022
Phase:
Study type: Observational

While appendectomy has been the main treatment of appendicitis for over 100 years, recent European studies found that, at least among highly selected patients, antibiotics alone can be an effective alternative. Surgeons and patients alike have a difficult time deciding if surgery or antibiotics are the best choice to treat appendicitis. The goal of the TRIAD is to evaluate the patients who are a part of the TRIAD implementation program and assess satisfaction and decisional regret for patients with appendicitis. This information will be used to inform the design of decision-support interventions to help patients improve their ability to make an informed decision in-line with their preferences and values.

NCT ID: NCT05843630 Recruiting - Acute Appendicitis Clinical Trials

Radiomic Modeling in Differentiating Uncomplicated From Complicated Acute Appendicitis

Start date: January 3, 2023
Phase:
Study type: Observational

Non-operative management (NOM) with antibiotics may be a safe alternative to surgery for uncomplicated appendicitis, but preoperative differentiation between uncomplicated and complicated appendicitis is challenging. The study aimed to develop a clinical-radiomics nomogram to distinguish uncomplicated from complicated appendicitis.

NCT ID: NCT05838248 Recruiting - Appendicitis Clinical Trials

Complex and Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX)

CASA-RELAX
Start date: January 24, 2023
Phase: N/A
Study type: Interventional

This prospective trial will randomize patients who have had an appendectomy to two different durations of antibiotic therapy depending on the status of the appendicitis. For simple appendicitis, patients will be randomized to peri-operative antibiotics or 24 hours duration. For complex appendicitis, patients will be randomized to 24 hours or 4 days duration. Data will be collected prospectively and test the hypothesis that shorter durations of antibiotics will be non-inferior to the longer durations.

NCT ID: NCT05761080 Recruiting - Clinical trials for Complicated Appendicitis

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

FTAA
Start date: April 22, 2021
Phase: Phase 4
Study type: Interventional

Evaluate the application of the new therapeutic model post Fast Track surgery, in complicated acute appendicitis, in pediatric population on the rate of complications postoperative in the form of abdominal abscesses.

NCT ID: NCT05746520 Recruiting - Clinical trials for Appendicitis Surgery

Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

NCT ID: NCT05691348 Recruiting - Appendicitis Clinical Trials

Same Day Ambulatory Appendectomy (SAMBA)

SAMBA
Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system: 1. Optimization of the care pathway, reducing the length of stay in hospital (a major issue in the context of the COVID-19 (coronavirus disease) pandemic) liberating patient beds and staff, and reducing the risk of nosocomial exposure. 2. Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds. 3. Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization. 4. Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.

NCT ID: NCT05641363 Recruiting - Migraine Clinical Trials

Comparison of Ketorolac at Three Doses in Children With Acute Pain

KETODOSE
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

Hospital Scene #1: A 6-year-old arrives in the Emergency Department at McMaster Children's Hospital (MCH) complaining of pain in his lower right side. His Dad explains the pain has been going on for a few hours and that Advil and Tyelnol haven't helped at all. He's anxious and concerned about his son because he never complains about pain - so this must be bad. After he has been seen by the doctor, the appendix appears to be the problem and the boy needs to have it removed. Dad wants his son's pain to go away but is worried because he once got a high dose of a medication and had some unwanted side effects. Hospital Scene #2: A 14-year-old girl has been experiencing migraine headaches for the past months and is awaiting an appointment with a specialist. Today, however, the pain is the worst it's been. Mom has picked her up from school and brought her to MCH not knowing what else to do to help her. The Advil and Tylenol have not improved her pain. She desperately wants the pain to go away but is worried because she read that some pain medicines are used without any studies done to see if they work and if they are safe. (https://www.ottawalife.com/article/most-medications-prescribed-to-children-have-not-been-ade quately-studied?c=9). In both cases, these children need medicine to help their pain. The treating doctors want to give them pain medicine that will 1) be safe and 2) make the pain go away. This is what parents and the child/teenager, and the doctors want too. Some pain medicines like opioids are often used to help with pain in children. Unfortunately, opioids can have bad side effects and can, when used incorrectly or for a long time, be addictive and even dangerous. A better option would be a non-opioid, like Ketorolac, which also helps pain but is safer and has fewer side effects. The information doctors have about how much Ketorolac to give a child, though, is what has been learned from research in adults. Like with any medication, the smallest amount that a child can take while still getting pain relief is best and safest. Why give more medicine and have a higher risk of getting a side effect, if a lower dose will do the trick? This is what the researchers don't know about Ketorolac and what this study aims to find out. Children 6-17 years old who are reporting bad pain when they are in the Emergency Department or admitted in hospital and who will be getting an intravenous line in their arm will be included in the study. Those who want to participate will understand that the goal of the study is to find out if a smaller amount of medicine improves pain as much as a larger amount. By random chance, like flipping a coin, the child will be placed into a treatment group. The difference between these treatment groups is the amount of Ketorolac they will get. One treatment will be the normal dose that doctors use at MCH, and the other two doses will be smaller. Neither the patient, parent nor doctor will know how much Ketorolac they are getting. Over two hours, the research nurse or assistant will ask the child how much pain they are in. Our research team will also measure how much time it took for the pain to get better, and whether the child had to take any other medicine to help with pain. The research team will also ask families and patients some questions to understand their perceptions of pain control, pain medicines and side effects they know of. This research is important because it may change the way that doctors treat children with pain, not just at MCH but around the world. The results of this study will be shared with doctors through conferences and scientific papers. It's also important that clinicians share information with parents and children so that they can understand more about pain medicines and how these medicines can be used safely with the lowest chance of side effects.

NCT ID: NCT05289713 Recruiting - Appendicitis Clinical Trials

Appendectomy vs. Symptomatic Treatment in Uncomplicated Acute Appendicitis Among Pediatric Patients

APPSYPP
Start date: March 10, 2023
Phase: N/A
Study type: Interventional

The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. Patients are recruited from all five Finnish university hospitals. Inclusion criteria are: 1) age 7-15 years, 2) imaging-confirmed uncomplicated acute appendicitis (no appendicolith, perforation, abscess, or tumor suspicion), and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency appendectomy or symptomatic treatment. In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. In order to ensure patient safety, symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. Primary outcome is treatment success at 30 days defined by not fulfilling any of the treatment failure criteria. In the surgery group, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In the symptomatic treatment group, treatment failure is defined as inability to discharge from hospital without appendectomy within 48 hours after randomization with a finding of histopathologically inflamed appendix, appendectomy during the initial hospital stay due to clinical progression of appendicitis with histopathologically and surgically confirmed complicated acute appendicitis, appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or any complication of appendicitis requiring general anesthesia. Predefined secondary outcomes include later appendectomies, recurrence of histopathologically confirmed appendicitis and associated symptoms, postintervention complications, return to normal daily activities, quality of, resolution of appendicitis in US imagining after 1 month of symptomatic treatment, comparison of US and MRI findings at presentation, and differences in serum biomarkers and fecal microbiota composition.

NCT ID: NCT05256901 Recruiting - Surgery Clinical Trials

Sugammadex vs Neostigmine Reversal in Pediatric Appendectomy

Start date: July 19, 2023
Phase: Phase 4
Study type: Interventional

This study is designed as a randomized controlled trial with patients assigned to neuromuscular reversal with either sugammadex or neostigmine/glycopyrrolate reversal. The study will not be blinded to the anesthesiologist to allow for appropriate decision-making on timing and dosage of reversal. This is a single-center study.

NCT ID: NCT05209061 Recruiting - Diabetes Clinical Trials

Mapping the Human Appendix Using Single Cell Sequencing

APPATA
Start date: February 1, 2023
Phase:
Study type: Observational [Patient Registry]

The overall purpose of this study is to describe the cellular composition of the human appendix and its gene expression using scRNAseq and scATACseq methods. This will potentially provide is with a complete and detailed map of the appendix´ immunological properties and its role in neuro-endocrine/metabolic functions. Our results will be held up against current knowledge of the appendix and its role in the human body and thus hopefully expand our understanding of this organ and the consequences of its removal by appendectomy.