The Role of Postoperative Antibiotics in Laparoscopic Cho... | NCT06607887

Studies
The Role of Postoperative Antibiotics in Laparoscopic Cholecystectomy

NCT06607887

Sponsor

Minia University Hospital

Status

Recruiting

Last Update Posted

Sep 23, 2024Actual

Enrollment

300Estimated

Phase

Phase 4

Conditions

Infection Wound
Antibiotic Resistant Infection

Interventions

IV antibiotic
Oral antibiotic

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2024Actual

Primary Completion Date

Nov 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Sep 19, 2024

First Submission Date that Met QC Criteria

Sep 19, 2024

First Posted Date

Sep 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2024

Last Update Posted Date

Sep 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IV antibiotic	Experimental		Drug: IV antibiotic
Oral Antibiotic	Active Comparator		Drug: Oral antibiotic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IV antibiotic	Drug	Parenteral prophylactic antibiotics (cefazolin), 1st dose at the time of induction of anesthesia, 2nd dose after 12hs from the surgery.	IV antibiotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical site infection	DSSI = deep surgical site infection; SSSI = superficial surgical site infection.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fever		4 weeks
Length of the hospital stay		4 weeks
Hematoma and Seroma formation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Asmaa A Elsayed	Contact	01095727201		asmaa.abdelfattah@pharm.sohag.edu.eg

Overall Officials

Name	Affiliation	Role
Asmaa A Elsayed, Ph.D.	Sohag University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minia University Hospital	Recruiting	Minya			Egypt

ID	Term
D014946	Wound Infection

ID	Term
D007239	Infections

Intervention Browse Module

MeSH Terms

ID	Term
D000900	Anti-Bacterial Agents

Ancestor Terms

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided