Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Prospective Randomized Control Study of Clinical Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis
• Intervention / Treatment: Drug: Cefotetan

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.

• Study Type: Interventional
• Enrollment (Actual): 529
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Suspected cholangitis and GB cancer
2. CBD stone history
3. Preoperative administration of antibiotics within 7days.
4. Suspected pregnancy
5. Open conversion.
6. Patients refuse this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Antibiotic treatment group; They were Antibiotic treatment group (AG, cefotetan 1g, 1 dose/prophylactic) before surgery.	Drug: Cefotetan; Cefotetan (as Disodium) 1 GM Injection before surgery; Other Names: antibiotics group
NO_INTERVENTION: Non-antibiotic treatment group; They were Non-antibiotics treatment such as cefotetan 1g before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical complication	surgical site infection	30days

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Investigators: Study Director: Jae Do Yang, Chonkbuk national university

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): September 25, 2017

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (ACTUAL): January 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: GB stone
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Anti-Infective Agents; Anti-Bacterial Agents; Cefotetan
• Other Study ID Numbers: ChonbukNUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No