- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789865
Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
Multicenter Prospective Randomized Clinical Trial Comparing Endoscopic Retrograde Appendicitis Therapy (ERAT) vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
Study Overview
Status
Conditions
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:
- 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.
- 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).
- 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.
- 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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yingchao Li, MD,PhD
- Phone Number: 0086-18991232662
- Email: lych123@126.com
Study Locations
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Shaanxi
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Hanzhong, Shaanxi, China, 723000
- 3201 Hospital of Hanzhong
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Contact:
- Zhufang Ma, MD
- Phone Number: 0086-18292172137
- Email: 1304101066@qq.com
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Xi'an, Shaanxi, China, 710061
- First Affiliated Hospital of Xian Jiaotong University
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Contact:
- Yingchao Li, MD,PhD
- Phone Number: 0086-18991232662
- Email: lych123@126.com
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Xi'an, Shaanxi, China, 710004
- Second Affiliated Hospital of Xi'an JiaoTong University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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).
|
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.
|
The patients will receive laparoscopic appendectomy according to standard routines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
duration of abdominal pain
Time Frame: up to 10 days
|
up to 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean hospital stay
Time Frame: up to 10 days
|
up to 10 days
|
duration of fever
Time Frame: up to 10 days
|
up to 10 days
|
duration of leukocytosis
Time Frame: up to 10 days
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up to 10 days
|
bed time
Time Frame: up to 10 days
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up to 10 days
|
rate of complication
Time Frame: during follow-up period of 1 year
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during follow-up period of 1 year
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rate of recurrence
Time Frame: during follow-up period of 1 year
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during follow-up period of 1 year
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rate of appendectomy
Time Frame: during follow-up period of 1 year
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during follow-up period of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yingchao Li, MD,PhD, First Affiliated Hospital Xi'an Jiaotong University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Disease Attributes
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Cecal Diseases
- Intraabdominal Infections
- Acute Disease
- Appendicitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Metronidazole
- Levofloxacin
- Ofloxacin
- Ertapenem
Other Study ID Numbers
- XJTU1AF-CRF-2015-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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