Antibiotics vs. Appendectomy for the Treatment of CT-Uncomplicated Acute Appendicitis in Adults

Not Applicable

Recruiting

• Conditions: Digestive System; Surgery

• Registration Number: PACTR202203751640059
• Lead Sponsor: EPH Kouba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Patients aged 15-65 years
- Acute uncomplicated appendicitis with a diameter between 6 - 14mm confirmed by an injected CT scan
- AIR score = 5

Exclusion Criteria

- Age over 65 years
- Complicated acute appendicitis (stercolith, peri-appendicular abcess or intraperitoneal fluid, perforation, pneumoperitoneum)
- Appendicular diameter > 14mm (injected CT)
- AIR score = 4
- History of inflammatory bowel disease
- Treatment with corticosteroids
- Pregnancy in progress
- Allergy to iodine
- Renal insufficiency (creatinine clearance <30 ml/min)
- Refusal to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall failure rate: defined as the number of patients operated on (Antibiotics group) or reoperated on (Appendectomy group) for postoperative complications (peritonitis, intestinal obstruction, incisional hernia) during one-year follow-up.

Secondary Outcome Measures

Name	Time	Method
- Recurrences rate: defined as the number of patients with a recurrence of acute appendicitis in the antibiotics group during one year of follow-up.<br>- Pain intensity on day 1: defined as the mean of the VAS values calculated on day 1.<br>- Quantity of analgesic received: mean in grams of analgesic received during hospitalization.<br>- Morbidity rate: number of postoperative complications according to the Clavien-Dindo classification.<br>- Readmission rate: number of re-hospitalizations for recurrence or complications.<br>- Length of hospital stay: number of days in hospital.<br>- Duration of physical disability: number of days the patient is unable to carry out daily activities.