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Optimizing the treatment for uncomplicated acute appendicitis: a multicenter study in China

Optimizing the treatment for uncomplicated acute appendicitis: a multicenter, prospective randomised double blind study in China

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018896
Enrollment
Unknown
Registered
2018-10-16
Start date
2021-12-31
Completion date
Unknown
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute appendicitis

Interventions

Group 1:Ceftazidime combined with ornidazole
Group 2:Ceftazidime

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old male and female; 2. Patients with acute appendicitis who were first visit within 48 hours of onset; 3. Clinical manifestations of suspected acute appendicitis, the following signs have at least two: 1) Acute right lower abdominal pain (including shifting pain in right lower quadrant or persistent right lower abdominal pain); 2) Right lower quadrant tenderness and rebound pain; 3) The white blood cell count is increased or greater than 10^9/L; 4) Increased body temperature or body temperature > 38.5 degree C for anal temperature or sputum temperature,or 38 degree C for mouth temperature; 5) CRP > 10mg/L in recently tested; 4. Patients with acute appendicitis diagnosed by imaging (ultrasound, CT or MRI) with the following signs: 1) The appendix diameter is over 6 mm; 2) Thickening of the appendix wall, contrast enhancement was seen in CT, or no thickening of the appendix wall but significant expansion of the appendix lumen; 3) Inflammatory edema around the appendix and a small amount of effusion; 4) Ultrasound to check the position of the maximum tender point, showing a concentric layered, incompressible sausage-like structure; 5) Hyperechoic submucosal structure partially or completely disappeared or progressive swollen in ultrasound examination; 6) Peripheral fat echo enhancement, may be accompanied by increased intravascular fat flow signal in ultrasound examination; 5. The patient or authorized family member agrees to participate in the study and sign a written consent form.

Exclusion criteria

Exclusion criteria: (1) Imaging confirmed appendiceal abscess or perforation; (2) The indirect sign of imaging includes the appendix stercolith; (3) Imaging confirmed the presence of soft tissue mass of the appendix and suspected appendiceal tumor; (4) Patients diagnosed with appendiceal phlegmona or diffuse peritonitis; (5) History of acute appendicitis; (6) Patients with history of chronic appendicitis; (7) Adverse reactions are known to occur in patients with leornidazole or cephalosporins; (8) Patients who had received at least two doses of antibiotics before this admission; (9) Infectious diseases requiring systemic anti-infective medication other than appendicitis; (10) Septic shock was diagnosed according to the criteria of sepsis 3.0; (11) Suspected inflammatory bowel disease (IBD) or definitive diagnosis of IBD; (12) Suspected tuberculosis or having a history of tuberculosis; (13) Patients with surgical implants (such as left ventricular assist device and peritoneal dialysis device); (14) Patients with contraindication for surgery; (15) Patients who have received abdominal or pelvic surgery in the past six months; (16) Patients with severe peripheral and central nervous system diseases or with a history of epilepsy; (17) Patients with severe chronic liver disease (child-pugh classification C); (18) Patients with serum creatinine was greater than or equal to 176.8 mol/L; (19) Pregnant or lactating women who have been pregnant or scheduled for nearly 3 months; (20) Low hematopoietic function; (21) Alcoholics; (22) Patients with severe systemic disease or serious complications requiring hospitalization, such as cardiopulmonary dysfunction, immune deficiency, and malignant tumors (chemotherapy); (23) Patients who have participanted other clinical trails in the past six months.

Design outcomes

Primary

MeasureTime frame
cure rate;

Secondary

MeasureTime frame
Mortality;length of stay;length of stay in ICU;medical cost;Recurrence rate of appendicitis;pain score;

Countries

China

Contacts

Public ContactJianan Ren

Jinling Hospital, Medical School of Nanjing University

jiananr@gmail.com+86 13605169808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026