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One Versus Five Days of Antibiotics After Appendectomy

NCT07563933 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a one-day course of antibiotics after appendectomy surgery works as well as a five-day course to prevent infections in children and adults (aged 10 years and older) with uncomplicated acute appendicitis (non-ruptured, non-gangrenous appendix). The main questions it aims to answer are:

* Does a one-day antibiotic regimen result in a similar rate of surgical site infections, intra-abdominal abscesses, or death within 30 days after surgery compared to a five-day regimen?
* What is the rate of hospital readmission, antibiotic-related side effects, and cost-effectiveness for each treatment duration?

Researchers will compare participants receiving 24 hours of intravenous antibiotics to participants receiving 5 days of antibiotics (1 day intravenous followed by 4 days oral) to see if the shorter course is non-inferior (not meaningfully worse) to the longer standard course.

Participants will:

* Undergo appendectomy for uncomplicated acute appendicitis
* Be randomly assigned to receive either one day or five days of postoperative antibiotics
* Receive follow-up at 30 days after surgery, including a telephone call to check for infections, readmissions, or other complications
* Allow study staff to collect information from their medical records regarding hospital stay, antibiotic side effects, and any need for reoperation or restarting antibiotics

Conditions

  • Post Operative Antibiotic Therapy of Acute Appendicitis

Interventions

DRUG

a single day (24 hours) post operative

• Short course (guideline course): 24 hours of postoperative IV antibiotics (ampicillin/sulbactam)

Sponsors & Collaborators

  • Ministry of Health and Population, Egypt

    lead OTHER_GOV

Principal Investigators

  • Shahinda kamal, BSc Pharmacy · Fayoum General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-10-30
Completion
2027-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563933 on ClinicalTrials.gov