跳至主要内容
临床试验/NCT04253899
NCT04253899招募中不适用

The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations

Marshall University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis

研究概览

简要总结

Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.

A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Men and women of all ages.
  • •Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
  • •Formal consent for the present study must be signed by the patient or his/her parents
  • •Patients with initial presentation of a phlegmon (abscess in evolution)

排除标准

  • •Patients with non-perforated appendicitis
  • •Presentation with initially non-perforated appendicitis but found perforation at surgery
  • •Patient with septic shock
  • •Patients who had previous appendectomy
  • •Current treatment of malignancy
  • •Immunocompromised patients
  • •Positive pregnancy test
  • •No consent for the study

研究组 & 干预措施

Standard pediatric group:

Active Comparator

patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)

干预措施: Appendectomy (Procedure)

Experimental pediatric group:

Experimental

patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)

干预措施: Observation (Other)

Standard adult group:

Active Comparator

patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)

干预措施: Appendectomy (Procedure)

Experimental adult group:

Experimental

Patients ≥18 yo with acute perforated appendicitis and observation (n=25)

干预措施: Observation (Other)

结局指标

主要结局

Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis

时间窗: 12 months

Determine rate and severity of complications after interval appendectomy

时间窗: 12 months

次要结局

  • Determine the rate of complete response after percutaneous drainage and antibiotic therapy(12 months)
  • Determine the mean surgical value (quality/cost) for each group(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Sanabria

Professor of Surgery

Marshall University

研究点 (1)

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