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The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis (other than for generalized peritonitis): a prospective, randomized, open-label, non-inferiority Phase III study.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515834-34-00
Acronym
PI2017_843_0002
Enrollment
1494
Registered
2024-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-20

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

Conditions

complicated acute appendicitis

Brief summary

proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the centre of disease control and prevention (CDC) (29) as infections that occur within 30 days of surgery AND appear to be related to the surgery AND affect the organ or the cavity around the surgical site (i.e. any anatomical structure – other than the incision – that is opened or handled during surgery) AND for which at least one sign defined in the protocol is observed

Detailed description

Quality of life prior to surgery and on discharge, using the SF36 questionnaires., The proportion of patients with superficial SSIs, The post-operative infection rates by POD30, including SSIs and remote infections, The number of antibiotic-free days between randomization and POD30., The description of the microbial flora, as found in the antibiogram of the per-operative sample that is collected in all cases, The balance between antibiotic therapy and microbial resistance. The antibiotic treatment will be considered to be adequate if no germs are found in the per-operative sample or if all of the detected germs are sensitive to the administered antibiotic therapy. The antibiotic treatment will be considered to be inadequate if the per-operative sample is positive for resistant germs, Morbidity and mortality according to the Dindo-Clavien classification (31) and the CCI, Slankamenac, Ann Surg, 2014; 260:757-62) (32), LOS, defined as the number of days of hospitalization between surgery and discharge, The rehospitalization rate, defined as rehospitalization during the study period

Interventions

DRUGMETRONIDAZOLE
DRUGCEFTRIAXONE
DRUGSODIUM CHLORIDE
DRUGLEVOFLOXACIN

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the centre of disease control and prevention (CDC) (29) as infections that occur within 30 days of surgery AND appear to be related to the surgery AND affect the organ or the cavity around the surgical site (i.e. any anatomical structure – other than the incision – that is opened or handled during surgery) AND for which at least one sign defined in the protocol is observed

Secondary

MeasureTime frame
Quality of life prior to surgery and on discharge, using the SF36 questionnaires., The proportion of patients with superficial SSIs, The post-operative infection rates by POD30, including SSIs and remote infections, The number of antibiotic-free days between randomization and POD30., The description of the microbial flora, as found in the antibiogram of the per-operative sample that is collected in all cases, The balance between antibiotic therapy and microbial resistance. The antibiotic treatment will be considered to be adequate if no germs are found in the per-operative sample or if all of the detected germs are sensitive to the administered antibiotic therapy. The antibiotic treatment will be considered to be inadequate if the per-operative sample is positive for resistant germs, Morbidity and mortality according to the Dindo-Clavien classification (31) and the CCI, Slankamenac, Ann Surg, 2014; 260:757-62) (32), LOS, defined as the number of days of hospitalization between surgery

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026