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Acute Appendicitis clinical trials

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NCT ID: NCT03324165 Active, not recruiting - Acute Appendicitis Clinical Trials

Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis

RCTAppAlg
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

Acute appendicitis is one of the most common causes of acute abdominal pain requiring surgical intervention. In the current era, with diagnostic imaging technique like Computed Tomography (CT), negative appendectomy rates have been greatly reduced. However, the radiation risk with CT poses as a concern. Rules for clinical decision guiding CT utilization is thus essential to minimize unnecessary CT scans, which not only poses a radiation risk but also contributes to increased healthcare costs. Through the development of an algorithm based on Alvarado Score for the management of acute appendicitis, investigators hope to reduce CT utilization with an acceptable negative appendectomy rate, and hence reducing unnecessary radiation and the healthcare costs involved.

NCT ID: NCT03257423 Enrolling by invitation - Acute Appendicitis Clinical Trials

Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects

MAPPAC
Start date: April 4, 2017
Phase: N/A
Study type: Interventional

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.

NCT ID: NCT03252561 Withdrawn - Acute Appendicitis Clinical Trials

TAP Block for Laparoscopic Appendicectomy in Adults

Start date: August 2014
Phase: N/A
Study type: Interventional

Laparoscopic (key-hole) appendicectomy is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. Opioids are associated with an increased incidence of nausea, vomiting and sedation which can complicate post-operative recovery. Different techniques of intraoperative infiltration of local anaesthetic to control postoperative pain are also being used. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, a reduction in post-operative nausea and vomiting and earlier hospital discharge. The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in the investigator's hospital.

NCT ID: NCT03236961 Active, not recruiting - Acute Appendicitis Clinical Trials

Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis

APPACII
Start date: April 3, 2017
Phase: N/A
Study type: Interventional

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. The aim of this randomized prospective study is to optimize antibiotic therapy for uncomplicated acute appendicitis by comparing different antibiotic regimens; intravenous antibiotic (ertapenem) followed by per oral antibiotic (levofloxacin and metronidazole) with only per oral antibiotics (moxifloxacin). Before randomization, the diagnosis of acute uncomplicated appendicitis is confirmed with a CT scan. The hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital resources are not necessary for the treatment of uncomplicated acute appendicitis and that per oral mono therapy is non-inferior to the combination of intravenous and per oral antibiotic therapy.

NCT ID: NCT03234296 Enrolling by invitation - Acute Appendicitis Clinical Trials

Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis

APPACIII
Start date: August 9, 2017
Phase: N/A
Study type: Interventional

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. Our previous APPAC study, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with CT-diagnosed uncomplicated appendicitis treated successfully with antibiotics within one-year follow-up. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. Already in 1886 Fitz noted that 1/3 of patients in a large series of autopsies from the pre-appendicectomy era had evidence of prior appendices inflammation suggesting spontaneous resolution of acute appendicitis. Acute appendicitis is thought to be similar to acute diverticulitis ("left-sided appendicitis") and this similarity has been shown in epidemiological studies. Recent studies have shown no benefit of antibiotic treatment in the treatment of uncomplicated diverticulitis with outpatient management without antibiotics proving safe and well-functioning. The aim of this randomised double-blinded study is to compare antibiotic therapy with placebo to evaluate the role of antibiotic therapy in the resolution of CT-diagnosed uncomplicated acute appendicitis. The hypothesis is that antibiotic therapy is necessary in the treatment of acute uncomplicated appendicitis and that antibiotic therapy is superior to spontaneous resolution (placebo) with the primary endpoint evaluated at ten days after the intervention.

NCT ID: NCT03198065 Recruiting - Acute Appendicitis Clinical Trials

Single-incision Laparoscopic Surgery in Acute Abdomen

Start date: June 17, 2017
Phase: N/A
Study type: Interventional

Since Semm et.al. reported the first case of laparoscopic appendectomy in 1983, minimally invasive surgery has become the main stay for treating of many surgical diseases. After the booming in the advancement of surgical instrument and breakthrough in surgical skills, the minimally invasive surgery has been widely applied to neurosurgery, spinal surgery, breast, thyroid, hernia surgery, etc. It has been proved that minimally invasive surgery is safe and effective, and further it achieves compatible results and outcomes in oncology and functional diseases. Minimally invasive surgery in alimentary tract, known as laparoscopic surgery, has been performed in gastric surgery (e.g. gastric cancer, tumor, functional disorders and bariatric surgery), hepatobiliary and pancreatic surgery (e.g. hepatectomy, cholecystectomy, and pancreatectomy), and colorectal surgery (e.g. colorectal cancer and functional bowel disease). Under a superior heritage of surgical skills from Taiwan university hospital, we introduced laparoscopic surgery in 1996 and currently, laparoscopic surgery becomes the mainstay of surgery in Yunlin branch. In 2015, there were 600 laparoscopic surgery in our hospital, while 150 colorectal laparoscopic surgery in the same year. In recent years, single-incisional laparoscopic surgery has emerged to become one of the focused topic in the world and seemly in our department. Through single-incision surgery, we attempted to minimize the incision wound to achieve better cosmesis and faster recovery. By the valuable clinical experiences gathering in our hospital (Yunlin branch) in recent 10 years, we contemplate two-step plans: first, by retrospective data collection, we can explain the clinical problems based on current statistical results. Second, based on prior (step 1) retrospective findings, a prospective study could be conducted for more evident results.

NCT ID: NCT03080103 Completed - Acute Appendicitis Clinical Trials

Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis

ACTUAA
Start date: June 1, 2017
Phase:
Study type: Observational

On September the 15th, 2015, Italian surgeons, radiologists and pathologists with a special interest and expertise in the diagnosis and management of Acute Appendicitis (AA), met up under the auspices of the Italian Society of Hospital Surgeons (ACOI) in Oristano (Italy) to constitute the ACTUAA collaborative working group. The main objectives of the working group are: To create a working basis for analyzing the diagnostic features, treatment modalities and outcomes of interest of both the antibiotic-first approach and appendectomy for patients with uncomplicated AA. To investigate the clinical, laboratory and radiologic modalities adopted for the diagnosis To determine the outcomes of patients treated with antibiotics or appendectomy in the short and long term periods. To compare results according to the type of intervention. To stratify the risk of recurrence for patients treated with antibiotics according to clinical, laboratory and radiology findings. To evaluate the sensibility and specificity of clinical and laboratory scores for the diagnosis of uncomplicated AA. To identify a subgroup of patients with uncomplicated AA for whom antibiotic treatment can be highly effective. General study design The study protocol is designed according to the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials". The study period is estimated to be of 12 month + 12 month of follow-up (with a second session of follow-up following 5-years), beginning on 01/04/2017. Participants All adult patients (aged over 18 years old) with suspected AA will be admitted to the Surgical Department of the nine participating Italian hospitals, where they will be studied carefully by the on call surgeon. Patients will be then informed of the study protocol and invited to give written consent for participation and for sensible data collection for scientific purposes. Subsequently, only patients who will undergo diagnostic imaging (as specified later) and from whom a written informed consent will be obtained, can be enrolled in the study and registered by each Center using a uniform electronic registration form and database. General characteristics, medical history, clinical findings, physical investigation, and blood tests will be reported in the medical record. Pain will be quantified by Visual Analogue Scale (VAS) scoring system before administrating any pain medications and after the treatments. In order to enter the study, patients will have to undergo diagnostic imaging (US and/or CT scan or MRI scan) and only the diagnosis of uncomplicated AA confirmed by diagnostic imaging will permit patient enrollment in the study. Specific aims of the ACTUAA Study The objective of this prospective non-randomized controlled, multicenter, multidisciplinary trial is to compare the antibiotic therapy and emergency appendectomy for the treatment of patients with uncomplicated AA(without abscess or free perforation), confirmed by US and/or CT or MRI scan. No changes in the daily practice regarding the diagnostic, clinical and treatment pathways will be required to the participating centers. However, only the patients with uncomplicated AA, confirmed by one of the above mentioned radiologic tools will be enrolled in the study. The decision on which of the tools are to be adopted will be up to the local lead surgeon. Primary Outcome Measure: Number of participants with complication-free treatment success, defined as success of the initial treatment with uncomplicated course. Secondary Outcome Measures: Length of hospital stay; Pain evaluation; Time to return to normal activity; Period of sick-leave; Complicated appendicitis with peritonitis identified at the time of surgical operation; Quality of life as assessed by the Short Form 12-scale (SF-12)

NCT ID: NCT02867072 Completed - Acute Appendicitis Clinical Trials

Laparoscopic Versus Open Appendectomy

Start date: January 2004
Phase: Phase 4
Study type: Interventional

Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.

NCT ID: NCT02803463 Completed - Acute Appendicitis Clinical Trials

Peritoneal Closure Versus Non Closure During Open Appendectomy

Start date: June 2016
Phase: N/A
Study type: Interventional

There has been no consensus over closure versus non closure of peritoneum during abdominal operations. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.

NCT ID: NCT02789865 Not yet recruiting - Acute Appendicitis Clinical Trials

Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis

Start date: May 2016
Phase: Phase 2
Study type: Interventional

Endoscopic retrograde appendicitis therapy (ERAT) is a new and minimally invasive method for the diagnosis and treatment of acute appendicitis.After a positive diagnosis of acute appendicitis is established by either colonoscopic direct-vision imaging or fluoroscopic endoscopic retrograde appendicography (ERA) imaging in patients with suspected acute appendicitis, the procedures to relieve the appendiceal lumen obstruction including appendiceal luminal irrigation, appendicolith removal, and stenting for drainage whenever necessary will be carried out. In this multicenter prospective randomized clinical trial, the patients with uncomplicated acute appendicitis will be divided into three groups randomly: ERAT group, antibiotic therapy group and appendectomy group. The primary outcome is duration of abdominal pain. The secondary outcomes include mean hospital stay, mean operative time, duration of fever, duration of leukocytosis, bed time, rate of complication, rate of recurrence and rate of appendectomy during follow-up period of 1 year.