Explanations for Negative Laparoscopic Appendectomies and Normal Laparoscopies. What Does the Patient Suffer From When the Appendix Proves to be Healthy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Detection of infection with Yersinia spp. (enterocolitica and/or pseudotuberculosis) by microbiological investigation of rectal swab
研究概览
简要总结
Trial The aim of the study is to investigate which infectious diseases might mimic the symptoms of acute appendicitis to a degree to cause a diagnostic laparoscopy or laparoscopic appendectomy. The primary outcome is to compare the incidence of Yersinia spp. infection in patients, who undergo surgery due to suspected appendicitis, between those with and without appendicitis detected by polymerase chain reaction on rectal swabs. The secondary outcomes are comparison of the incidence of bacterial pathogens (Campylobacter spp., Salmonella spp., Shigella spp., Aeromonas spp.) and Enterobius vermicularis in the two groups. Rectal swabs, appendix swabs, and blood samples are collected prospectively and research biobanks will be established. Initially, the rectal samples and serology samples will be investigated, and possible biomarkers and results of the appendix swabs will be evaluated at a later time point.
Ethics The trial will be conducted according to the Helsinki II Declaration after approval from both the local Health Research Ethics Committee and the Danish Data Protection Agency. An informed written consent will be collected from the participants prior to inclusion in the study. Data will be stored according to the approval from the Danish Data Protection Agency. This study is conducted in patients with suspected appendicitis. These patients are fully awake and conscious at time of inclusion. The patients included in this study will not experience any adverse effects due to their participation.
详细描述
Aim The aim of the study is to investigate which infectious diseases might mimic the symptoms of acute appendicitis to a degree that cause a diagnostic laparoscopy or laparoscopic appendectomy.
Primary outcome A comparison of the incidence of Yersinia spp. (enterocolitica and/or pseudotuberculosis) infection diagnosed by PCR on rectal swabs in the two groups: patients with histopathological confirmed inflammation (appendicitis group) and patients with one of the following: a histopathological normal appendix without inflammation, mesenteric lymphadenitis, or a normal diagnostic laparoscopy (normal appendix group).
Secondary outcomes A comparison of the incidence of other microbes: Campylobacter spp., Salmonella spp., Shigella spp., and Aeromonas spp. found by PCR of rectal swabs in the two groups: normal appendix versus appendicitis group.
Patients positive for Yersinia spp. will be evaluated individually in subgroups of the two groups: appendicitis group and normal appendix group. Serological investigation for Yersinia will be conducted if funding is achieved.
A comparison of the incidence of Enterobius vermicularis found in the histopathological examination in the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspicion of acute appendicitis and planned for diagnostic laparoscopy
- •Written informed consent after written and verbal information
排除标准
- •Cannot understand, read or speak Danish
- •Known with inflammatory bowel disease
- •Other intra-abdominal pathology than appendicitis requiring other surgical intervention or treatment (diagnosed either perioperatively, at a preoperative CT-scan, or shortly after the surgery in the histopathological examination)
- •Not undergoing diagnostic laparoscopy, laparoscopic appendectomy, or open appendectomy
- •Use of antimicrobial agents within two weeks prior to inclusion until actual admission for acute abdominal pain
结局指标
主要结局
Detection of infection with Yersinia spp. (enterocolitica and/or pseudotuberculosis) by microbiological investigation of rectal swab
时间窗: We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year.
Specimens (rectal swab) collected prior to surgery are immediately frozen at -80°C and stored at Herlev Hospital in a research biobank. When the last patient has concluded the trial, a fraction of the collected specimens from each patient is sent to the Department of Clinical Microbiology, Hvidovre Hospital and thereafter investigated with a real time PCR for Yersinia spp. These results are noted in the patient's eCRF, but not in the patient's medical record. Samples with a positive PCR result will be cultured for Yersinia spp. and in case of positive culture results, susceptibility testing will be performed (secondary outcome). Hereafter, the collected human material and the cultured Yersinia enterocolitica will be frozen at -80°C and stored for ten years at Hvidovre Hospital as a biobank for future research.
次要结局
- Serology of Yersinia enterocolitica(We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year.)
- Detection of infection with Yersinia spp. by either serology or PCR for Yersinia spp.(We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year.)
- Detection of Shigella spp.(We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year.)
- Detection of Campylobacter spp.(We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year.)
- Detection of Aeromonas spp.(We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year.)
- Detection of Salmonella spp.(We follow every patient from admission through surgery and until pathology report approximately ten days after surgery. The analyses are done after the last patient has concluded the trial. We expect the data collection process to take about a year.)