Overview

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

Status:
Unknown status
Trial end date:
2019-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborators:
3201 Hospital in Hanzhong
3201 Hospital of Hanzhong
Second Affiliated Hospital of Xi'an Jiaotong University
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ertapenem
Levofloxacin
Metronidazole
Ofloxacin
Criteria
Inclusion Criteria:

- patients with Alvarado scores ≥7 (with or without US/CT) diagnosed of uncomplicated
acute appendicitis

- patients with Alvarado scores <7 but US/CT suggested uncomplicated acute appendicitis
or could not exclude acute appendicitis.

Exclusion Criteria:

- perforated appendicitis

- periappendiceal abscess

- contraindications for colonoscopy

- allergy to contrast media or iodine

- pregnancy

- unable to cooperate or provide informed consent