Health TrialsbyHealthPanel

The Role of Postoperative Antibiotics in Laparoscopic Cholecystectomy

ConditionsInfection WoundAntibiotic Resistant Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinia University Hospital

About this trial

Comparison between postoperative parenteral prophylactic antibiotics, and oral antibiotics regarding the incidence of post laparoscopic cholecystectomy infection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (aged above 18 years) undergoing laparoscopic cholecystectomy.

Disqualifiers

patients with comorbidities (Diabetes, malignancies, Immunosuppressed). Lost of follow-up. Patients received antibiotics within 72 hr before admission. Complicated cases involved, gangrenous and perforated cholecystitis and abscess.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IV antibiotic

    Drug

    Parenteral prophylactic antibiotics (cefazolin), 1st dose at the time of induction of anesthesia, 2nd dose after 12hs from the surgery.

  • Oral antibiotic

    Drug

    Parenteral prophylactic antibiotic (cefazolin), dose at the time of induction of anesthesia and then oral antibiotic for five days postoperative.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: IV antibioticExperimental treatment 1 intervention
Group B: Oral AntibioticActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical site infection

DSSI = deep surgical site infection; SSSI = superficial surgical site infection.

Time frame
4 weeks

Secondary outcomes

1

Fever

Time frame
4 weeks
2

Length of the hospital stay

Time frame
4 weeks
3

Hematoma and Seroma formation

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University Hospital

Lead sponsor

Sohag University

Sponsor institution

Source ClinicalTrials.gov
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