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Endoscopic retrograde appendicitis therapy versus antibiotics for treatment of acute uncomplicated appendicitis: an open-label, inferiority, randomized controlled trial

Endoscopic retrograde appendicitis therapy versus antibiotics for treatment of acute uncomplicated appendicitis: an open-label, inferiority, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077218
Enrollment
Unknown
Registered
2023-11-01
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

acute appendicitis

Interventions

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged 18 years or older (no upper age limit); 2) Clinical suspicion of AUA and confirmed by CT scan: a. An appendiceal diameter larger than 6 mm and smaller than 15 mm with a thickened, contrast-enhanced wall along with periappendiceal edema and/or minor fluid collection, with or without appendicolith(s). b. The absence of the criteria of complicated acute appendicitis (presence of gangrene, perforation, abscess, or suspicion of tumor). 3) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Complicated acute appendicitis in a CT scan: presence of gangrene, perforation, periappendicular abscess or suspicion of a tumor; 2) Concurrent acute abdominal conditions, diffuse peritonitis, hemodynamic instability, or sepsis; 3) Severe systemic illness, eg, malignancy requiring active treatment (eg, chemotherapy), a medical condition requiring immunosuppressant medication; 4) Allergy or contraindication to proposed antibiotic therapy; 5) Pregnancy or lactating; 6) Inability to co-operate and give informed consent; 7) Allergy to laxative, contrast media, or iodine; 8) Past history of inflammatory bowel disease (IBD) or intestinal tuberculosis; 9) Actively taking metformin; 10) Kidney insufficiency or serum creatinine value exceeding the upper reference limit; 11) Another infection currently treated with systemic antibiotics; 12) Long-term use of steroids or anticoagulant therapy; 13) Prior enrollment in the study or other investigational drug or vaccine while on study treatment;

Design outcomes

Primary

MeasureTime frame
Treatment success rate;

Secondary

MeasureTime frame
Overall complication rate;The length of hospital stay and the amount of sick leave;Postintervention pain scores (VAS score);Postintervention quality of life;Patient-reported resolution of symptoms;Overall treatment costs;

Countries

China

Contacts

Public ContactXin Yang

The First Affiliated Hospital of Chongqing Medical University

305307293@qq.com+86 138 8377 5022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026