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

NCT02789865 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-06-03

No results posted yet for this study

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.

Conditions

  • Acute Appendicitis

Interventions

DRUG

Ertapenem, Levofloxacin and Metronidazole

The patients will be treated with intravenous broad-spectrum antibiotics (Ertapenem 1g/d) for 3 days and oral antibiotics (Levofloxacin 500mg once daily and Metronidazole 500mg 3 times per day) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated.

PROCEDURE

Endoscopic retrograde appendicitis therapy (ERAT)

The procedures of ERAT will be performed as below：1.Cannulation of the appendiceal lumen. 2.Endoscopic retrograde appendicography (ERA). 3.Irrigation and appendicolith removal. 4.Stenting for drainage.

PROCEDURE

Appendectomy

The patients will receive laparoscopic appendectomy according to standard routines.

Sponsors & Collaborators

  • 3201 Hospital in Hanzhong

    collaborator OTHER

  • Second Affiliated Hospital of Xi'an Jiaotong University

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Yingchao Li, MD,PhD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-04-30
Completion
2019-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789865 on ClinicalTrials.gov