NCT06607887

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 19, 2024

Last Update Submit

September 19, 2024

Conditions

Infection WoundAntibiotic Resistant Infection

Keywords

antibioticprophylaxischolecystectomypostoperative

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

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

    4 weeks

Secondary Outcomes (3)

  • Fever

    4 weeks

  • Length of the hospital stay

    4 weeks

  • Hematoma and Seroma formation

    4 weeks

Study Arms (2)

IV antibiotic

EXPERIMENTAL
Drug: IV antibiotic

Oral Antibiotic

ACTIVE COMPARATOR
Drug: Oral antibiotic

Interventions

IV antibioticDRUG

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

IV antibiotic
Oral antibioticDRUG

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

Oral Antibiotic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Wound Infection

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Asmaa A Elsayed, Ph.D.

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa A Elsayed

CONTACT

01095727201asmaa.abdelfattah@pharm.sohag.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of clinical pharmacy

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

August 30, 2024

Primary Completion

November 30, 2024

Study Completion

December 30, 2024

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations

EG(1)