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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

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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Drug: Ertapenem, Levofloxacin and Metronidazole Procedure: Endoscopic retrograde appendicitis therapy (ERAT) Procedure: Appendectomy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Clinical Trial Comparing Endoscopic Retrograde Appendicitis Therapy (ERAT) vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
Study Start Date : May 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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

Active Comparator: Appendectomy group
The patients will receive laparoscopic appendectomy according to standard routines.
Procedure: Appendectomy
The patients will receive laparoscopic appendectomy according to standard routines.




Primary Outcome Measures :
  1. duration of abdominal pain [ Time Frame: up to 10 days ]

Secondary Outcome Measures :
  1. mean hospital stay [ Time Frame: up to 10 days ]
  2. duration of fever [ Time Frame: up to 10 days ]
  3. duration of leukocytosis [ Time Frame: up to 10 days ]
  4. bed time [ Time Frame: up to 10 days ]
  5. rate of complication [ Time Frame: during follow-up period of 1 year ]
  6. rate of recurrence [ Time Frame: during follow-up period of 1 year ]
  7. rate of appendectomy [ Time Frame: during follow-up period of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789865


Contacts
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Contact: Yingchao Li, MD,PhD 0086-18991232662 lych123@126.com

Locations
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China, Shaanxi
3201 Hospital of Hanzhong Not yet recruiting
Hanzhong, Shaanxi, China, 723000
Contact: Zhufang Ma, MD    0086-18292172137    1304101066@qq.com   
Second Affiliated Hospital of Xi'an Jiaotong University Active, not recruiting
Xi'an, Shaanxi, China, 710004
First Affiliated Hospital of Xian Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710061
Contact: Yingchao Li, MD,PhD    0086-18991232662    lych123@126.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
3201 Hospital in Hanzhong
Second Affiliated Hospital of Xi'an Jiaotong University
Investigators
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Principal Investigator: Yingchao Li, MD,PhD First Affiliated Hospital Xi'an Jiaotong University

Publications:
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02789865     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2015-010
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Acute appendicitis
Endoscopic retrograde appendicitis therapy
Endoscopic retrograde appendicography
Endoscopic therapy
Appendectomy
Antibiotic Therapy
Additional relevant MeSH terms:
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Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Metronidazole
Levofloxacin
Ofloxacin
Ertapenem
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors