Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02789865
Study type Interventional
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Yingchao Li, MD,PhD
Phone 0086-18991232662
Email lych123@126.com
Status Not yet recruiting
Phase Phase 2
Start date May 2016
Completion date April 2019

See also
  Status Clinical Trial Phase
Completed NCT01697059 - Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis N/A
Completed NCT04649996 - Variation in Acute Appendicitis During COVID-19 Pandemic in Italy
Completed NCT04387370 - The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?
Completed NCT04030741 - Non-operative Treatment of Acute Non-perforated Appendicitis Phase 2/Phase 3
Recruiting NCT04860570 - Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?
Withdrawn NCT05724628 - Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations Phase 1
Completed NCT01024439 - Transumbilical Single Incision Versus Conventional Three Incisions Laparoscopic Appendicectomy N/A
Completed NCT02714023 - Water And Saline Head-to-head In The Blinded Evaluation Study Trial N/A
Active, not recruiting NCT03324165 - Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis N/A
Active, not recruiting NCT01022567 - Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis N/A
Not yet recruiting NCT06051825 - Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis
Not yet recruiting NCT06059365 - Clinical Trial for a Outpatient Clinical Management for Complicated Acute Appendicitis N/A
Recruiting NCT04947748 - Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous N/A
Completed NCT04615728 - MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
Terminated NCT04207645 - Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis
Completed NCT02731924 - Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
Completed NCT05104346 - Presentation and Outcomes of Acute Appendicitis During COVID Pandemic N/A
Completed NCT03886896 - Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy Phase 4
Not yet recruiting NCT01720082 - Laparoscopic Appendectomy by Multi-port vs Single Port. Phase 3
Completed NCT01348464 - A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy N/A