Comparative study of three different antibiotic combinations used for the management of acute appendicitis

Prospective randomized comparative study of efficiency and safety of gentamicin with metronidazole, cefuroxime with metronidazole, and ertapenem in the management of community-acquired acute appendicitis in patients who are also treated by surgical management of intra-abdominal infections

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15780064

Enrollment

225

Registered

2020-10-29

Start date

2020-11-09

Completion date

Unknown

Last updated

2026-05-04

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

Conditions

Acute appendicitis Digestive System Acute appendicitis

Interventions

Patients will be treated with surgery as usual, and one of three (combinations of) antibiotics: gentamicin+metronidazole, cefuroxime+metronidazole and ertapenem. After signing an agreement to partici

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Examined in the ER abdominal surgery department of UCML 2. Adults aged =18 years 3. Healthy individuals, no other illnesses 4. Diagnosed with acute appendicitis 5. Indicated for surgery

Exclusion criteria

Exclusion criteria: 1. Minors aged <18 years 2. Polymorbid individual 3. Patient with a serious illness 4. Pregnant or breastfeeding women 5. Known renal impairment

Design outcomes

Primary

Measure	Time frame
1. Differential blood count (DBC), C-reactive protein (CRP), albumins and markers of renal function (blood urea, creatinine and glomerular filtration rate (GFR)) measured using blood samples taken at baseline, on the second day after surgery and the day of discharge from the hospital 2. Urine specific gravity, pH, proteins, glucose, bilirubin, urobilinogen, white and red blood cells, methylketones, haemoglobin in urine and sediment in urine (white and red blood cells, bacteria and epithelial cells) measured using urine samples taken at baseline, on the second day after surgery and the day of discharge from the hospital 3. E. coli spp. in the rectum measured using rectal swab at baseline and day of discharge 4. Pathological diagnostics using microscopy and sterile instruments as soon as the appendix is safely removed. If the surgery is going to be in the night, then the material will be transferred in the morning. 5. Microbiome studied using 16S rDNA sequencing after the appendix is safely removed and the pathologist has performed the diagnostics	—

Measure

Time frame

1. Differential blood count (DBC), C-reactive protein (CRP), albumins and markers of renal function (blood urea, creatinine and glomerular filtration rate (GFR)) measured using blood samples taken at baseline, on the second day after surgery and the day of discharge from the hospital 2. Urine specific gravity, pH, proteins, glucose, bilirubin, urobilinogen, white and red blood cells, methylketones, haemoglobin in urine and sediment in urine (white and red blood cells, bacteria and epithelial cells) measured using urine samples taken at baseline, on the second day after surgery and the day of discharge from the hospital 3. E. coli spp. in the rectum measured using rectal swab at baseline and day of discharge 4. Pathological diagnostics using microscopy and sterile instruments as soon as the appendix is safely removed. If the surgery is going to be in the night, then the material will be transferred in the morning. 5. Microbiome studied using 16S rDNA sequencing after the appendix is safely removed and the pathologist has performed the diagnostics

—

Secondary

Measure	Time frame
Complications of appendectomy measured clinically after 30 days	—

Countries

Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026