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

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ClinicalTrials.gov Identifier: NCT02789865
Recruitment Status : Unknown
Verified April 2016 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Collaborators:
3201 Hospital in Hanzhong
Second Affiliated Hospital of Xi'an Jiaotong University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Tracking Information
First Submitted Date  ICMJE April 24, 2016
First Posted Date  ICMJE June 3, 2016
Last Update Posted Date June 3, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2016)
duration of abdominal pain [ Time Frame: up to 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2016)
  • mean hospital stay [ Time Frame: up to 10 days ]
  • duration of fever [ Time Frame: up to 10 days ]
  • duration of leukocytosis [ Time Frame: up to 10 days ]
  • bed time [ Time Frame: up to 10 days ]
  • rate of complication [ Time Frame: during follow-up period of 1 year ]
  • rate of recurrence [ Time Frame: during follow-up period of 1 year ]
  • rate of appendectomy [ Time Frame: during follow-up period of 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
Official Title  ICMJE Multicenter Prospective Randomized Clinical Trial Comparing Endoscopic Retrograde Appendicitis Therapy (ERAT) vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
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.
Detailed Description

Intervention

The patients with uncomplicated acute appendicitis will be divided into three groups randomly: ERAT group, antibiotic therapy group and appendectomy group.

1) ERAT group: In preparation for ERAT, low-pressure cleansing enemas (500 mL normal saline solution per enema) will be administered for three times before the procedures for bowel preparation. Antibiotic therapy (levofloxacin + metronidazole) will be intravenously administrated to the patients in the perioperative period.

The procedures of ERAT will be performed as below:

  1. Cannulation of the appendiceal lumen: Colonoscopic examination under direct vision of the whole colon, ileocecal junction and terminal ileum will be performed to exclude other abnormalities first, and focus on the appendiceal orifice and the surrounding mucosa. Colonoscope attached by a transparent cap will be positioned close to the appendiceal orifice. Gerlach's valve will be pushed aside using the transparent cap, a standard catheter loaded with a 0.035-inch guidewire (loop-tip or hydrophilic-tip) will be placed in the appendiceal orifice. The guidewire will be probed gently to insert into the appendiceal lumen. The catheter will be then subsequently moved forward after the guidewire inserting deeply into the lumen under fluoroscopic guidance.
  2. Endoscopic retrograde appendicography (ERA): After cannulation of the appendiceal lumen, decompression of lumen will be achieved by suction using a 5-mL syringe attached to the catheter. A soluble contrast agent (iobitridol) will be then used to fill the appendix while being monitored by fluoroscopy to check the radiographic features of the appendix (including position, length, contour, mobility, intraluminal content and inner diameter of appendiceal lumen).
  3. Irrigation and appendicolith removal: The appendiceal lumen will be irrigated with normal saline solution to clear away the pus and the sand-like appendicoliths, while the large appendicoliths will be extracted using a balloon catheter or an extraction basket.
  4. Stenting for drainage: If the pus is massive or the lumen is stenosis, a plastic straight stent (8.5F) will be placed into the lumen over the guidewire for luminal decompression with the plan to retrieve the stent after about one week.

2) Antibiotic therapy group: The patients will be treated with intravenous broad-spectrum antibiotics (Carbapenems) for 3 days and oral antibiotics (Levofloxacin and Metronidazole) 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.

3) Appendectomy group: The patients will undergo laparoscopic appendectomy according to standard routines.

Follow-up and outcome measures

Follow-up will be performed until the end of the study period. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Appendicitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Antibiotic therapy group
    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.
    Intervention: Drug: Ertapenem, Levofloxacin and Metronidazole
  • Experimental: ERAT group
    The patients will receive emergent endoscopic retrograde appendicitis therapy (ERAT).
    Intervention: Procedure: Endoscopic retrograde appendicitis therapy (ERAT)
  • Active Comparator: Appendectomy group
    The patients will receive laparoscopic appendectomy according to standard routines.
    Intervention: Procedure: Appendectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2016)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02789865
Other Study ID Numbers  ICMJE XJTU1AF-CRF-2015-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor  ICMJE First Affiliated Hospital Xi'an Jiaotong University
Collaborators  ICMJE
  • 3201 Hospital in Hanzhong
  • Second Affiliated Hospital of Xi'an Jiaotong University
Investigators  ICMJE
Principal Investigator: Yingchao Li, MD,PhD First Affiliated Hospital Xi'an Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP