NCT02789865

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2016

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 3, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

April 24, 2016

Last Update Submit

May 29, 2016

Conditions

Acute Appendicitis

Keywords

Acute appendicitisEndoscopic retrograde appendicitis therapyEndoscopic retrograde appendicographyEndoscopic therapyAppendectomyAntibiotic Therapy

Outcome Measures

Primary Outcomes (1)

  • duration of abdominal pain

    up to 10 days

Secondary Outcomes (7)

  • mean hospital stay

    up to 10 days

  • duration of fever

    up to 10 days

  • duration of leukocytosis

    up to 10 days

  • bed time

    up to 10 days

  • rate of complication

    during follow-up period of 1 year

  • +2 more secondary outcomes

Study Arms (3)

Antibiotic therapy group

ACTIVE COMPARATOR

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.

Drug: Ertapenem, Levofloxacin and Metronidazole

ERAT group

EXPERIMENTAL

The patients will receive emergent endoscopic retrograde appendicitis therapy (ERAT).

Procedure: Endoscopic retrograde appendicitis therapy (ERAT)

Appendectomy group

ACTIVE COMPARATOR

The patients will receive laparoscopic appendectomy according to standard routines.

Procedure: Appendectomy

Interventions

Ertapenem, Levofloxacin and MetronidazoleDRUG

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.

Antibiotic therapy group
Endoscopic retrograde appendicitis therapy (ERAT)PROCEDURE

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.

ERAT group
AppendectomyPROCEDURE

The patients will receive laparoscopic appendectomy according to standard routines.

Appendectomy group

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • perforated appendicitis
  • periappendiceal abscess
  • contraindications for colonoscopy
  • allergy to contrast media or iodine
  • pregnancy
  • unable to cooperate or provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

3201 Hospital of Hanzhong

Hanzhong, Shaanxi, 723000, China

Location

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (3)

  • Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.

    PMID: 21550483BACKGROUND

  • Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.

    PMID: 26080338BACKGROUND

  • Liu BR, Ma X, Feng J, Yang Z, Qu B, Feng ZT, Ma SR, Yin JB, Sun R, Guo LL, Liu WG. Endoscopic retrograde appendicitis therapy (ERAT) : a multicenter retrospective study in China. Surg Endosc. 2015 Apr;29(4):905-9. doi: 10.1007/s00464-014-3750-0. Epub 2014 Aug 9.

    PMID: 25106722BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

ErtapenemLevofloxacinMetronidazoleAppendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yingchao Li, MD,PhD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingchao Li, MD,PhD

CONTACT

0086-18991232662lych123@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2016

First Posted

June 3, 2016

Study Start

May 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2019

Last Updated

June 3, 2016

Record last verified: 2016-04

Locations

CN(3)