Effectiveness of Prophylactic Antibiotics Therapy in Lapa... | NCT04726046

Studies
Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

NCT04726046

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Jan 27, 2021Actual

Enrollment

529Actual

Phase

Phase 1

Conditions

Cholecystitis

Interventions

Cefotetan

Countries

Not provided

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 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2014Actual

Primary Completion Date

Aug 1, 2015Actual

Completion Date

Sep 25, 2017Actual

First Submitted Date

Sep 18, 2017

First Submission Date that Met QC Criteria

Jan 25, 2021

First Posted Date

Jan 27, 2021Actual

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

Jan 25, 2021

Last Update Posted Date

Jan 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria.

They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

Detailed Description

529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

529Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antibiotic treatment group	Experimental	They were Antibiotic treatment group (AG, cefotetan 1g, 1 dose/prophylactic) before surgery.	Drug: Cefotetan
Non-antibiotic treatment group	No Intervention	They were Non-antibiotics treatment such as cefotetan 1g before surgery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cefotetan	Drug	Cefotetan (as Disodium) 1 GM Injection before surgery	Antibiotic treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical complication	surgical site infection	30days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who have diagnosed -cholecystitis with / without GB stone, GB polyp

Exclusion Criteria:

Suspected cholangitis and GB cancer
CBD stone history
Preoperative administration of antibiotics within 7days.
Suspected pregnancy
Open conversion.
Patients refuse this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jae Do Yang	Chonkbuk national university	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015313	Cefotetan

Ancestor Terms

ID	Term
D002513	Cephamycins
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577

Browse Leaves

Not provided

Browse Branches

Not provided