Polymerase Chain Reaction and Cultivation of the Peritoneal Fluid at Operation for Appendicitis and Postoperative Enteral Antibiotic Treatment. A Feasibility and Non-inferiority Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PCR answer within 24 hours
研究概览
简要总结
Patients diagnosed with acute appendicitis receives antibiotics during the operation, and only patients where the surgeon suspects a complicated appendicitis with spread inflammation to the abdominal cavity receive antibiotics for 3 days postoperative.
In a previous study at the surgical department, the investigators were able to show that the surgeon's assessment during the surgery of whether the appendicitis are complicated or not is very uncertain. This means that some patients receive antibiotics after surgery for no reason, and others might have benefited from antibiotics. The aim of this study is to solve this problem.
By extracting some of the peritoneal fluid, it is possible to investigate whether there are bacteria or not in the abdominal cavity. Today when the fluid is cultivated, the answer will appear after 3-4 days. Therefore a new method is needed which confirms the presence of bacteria in the abdominal cavity within 24 hours.
In this study growth of bacteria in cultivation is examined and determined within 24 hours. The study also want to use PCR analysis. It is a special technique, which examines the fluid from the abdominal cavity for bacteria and provide answer within a few hours. It is investigated whether it is possible to perform this method in the daily routine of the department.
New research also shows that if patients needs antibiotics after surgery they can be treated with tablets instead of injection into the blood vessel. Antibiotic treatment with tablets will mean that the patient can be discharged earlier.
The primary purpose of this study is to investigate whether it is possible with the PCR technique or cultivation to determine whether there are bacteria in the abdominal cavity of patients undergoing surgery for acute appendicitis or not, so that any continued antibiotic treatment after surgery can be targeted to the individual patient. The secondary purpose is to investigate whether antibiotic treatment with tablets are as effective as getting antibiotics into the blood vessel.
The patients participating in the project will undergo the usual routine treatment and surgery. The only exception is retrieval of the naturally occurring fluid from the abdominal cavity. This will be done during the operation by special suction equipment that can be fitted to the usual operating equipment. It will not cause any discomfort or inconvenience to the patient. The technique of extracting fluid from the abdominal cavity has been used in previous studies of patients operated on for acute appendicitis.
The benefit for the patient will be a more targeted antibiotic treatment so that both unnecessary treatment is avoided, and patients who previously would not have received treatment can benefit from this. For society a more targeted antibiotic treatment will mean less risk of developing resistance and less hospitalization.
详细描述
Aim The primary aim is to investigate whether it is possible to determine if there are bacteria in the patient's peritoneal fluid either from PCR (polymerase chain reaction) or cultivation within 24 hours in patients undergoing surgery for acute appendicitis.
The secondary purpose is to investigate whether oral administered postoperative antibiotic treatment is non-inferior to prior standard intravenous administration therapy focusing on wound infection and intra-abdominal abscess.
The clinical issues
Previous studies from our department have shown that both over- and under treatment with antibiotics in patients operated for acute appendicitis is reality. It has not previously been possible to control the treatment based on the result of peritoneal fluid culture, because the final response to conventional cultivation is first available after a 3-4 days. The PCR (polymerase chain reaction) technique allows diagnostics within hours.
The second problem is that conventional postoperative antibiotic treatment is most often the only reason for the patient to remain hospitalized for at least 3 days. With oral antibiotic treatment the patient can be treated at home.
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
- •Patients undergoing diagnostic laparoscopy with suspected acute appendicitis
- •Admitted by the Emergency Department (FAM), at Odense University Hospital (OUH) or Svendborg
- •Gets a laparoscopic appendectomy.
- •Speaks and understands Danish
排除标准
- •Age under 18
- •Pregnant or breastfeeding
- •Language difficulties
- •Sepsis preoperatively assessed via the SIRS criteria leading to preoperatively administered antibiotics.
- •Patients with known gastrointestinal disorders as chronic inflammatory bowel disease or previous cancer disease.
- •Open appendectomy
- •Other illness than acute appendicitis
结局指标
主要结局
PCR answer within 24 hours
时间窗: 24 hours after surgery
A sample of peritoneal fluid is analysed with the PCR-method. The outcome is either positive (detection of bacterial DNA) or negative (no detection of bacterial DNA)
Complications
时间窗: 30 days follow up
Wound infection, intraabdominal abscess and other
Cultivation answer within 24 hours
时间窗: 24 hours after surgery
A sample of peritoneal fluid is observed for growth of bacteria in Department of Clinical Microbiology within 24 hours after surgery. The answer is either positive (growth of bacteria) or negative (no growth of bacteria).
次要结局
- Descriptive data - sex(1 day)
- Descriptive data - height(1 day)
- Descriptive data - smoking status(1 day)
- Descrptive data - alcohol status(1 day)
- Descrriptive data - weight(1 day)
- Descriptive data - American Society of Anesthesiologists (ASA) score(1 day)
- Descriptive data - Systemic Inflammatoric Response Syndrome (SIRS) criteria(1 day)