NCT04726046

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
529

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
Last Updated

January 27, 2021

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

September 18, 2017

Last Update Submit

January 25, 2021

Conditions

Cholecystitis

Keywords

GB stone

Outcome Measures

Primary Outcomes (1)

  • surgical complication

    surgical site infection

    30days

Study Arms (2)

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

CefotetanDRUG

Cefotetan (as Disodium) 1 GM Injection before surgery

Also known as: antibiotics group
Antibiotic treatment group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholecystitis

Interventions

Cefotetan

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CephamycinsCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jae Do Yang

    Chonkbuk national university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

January 27, 2021

Study Start

April 1, 2014

Primary Completion

August 1, 2015

Study Completion

September 25, 2017

Last Updated

January 27, 2021

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share