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OpenTrials
Completed

NCT Number: NCT04726046

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.

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefotetan

Drug

Cefotetan (as Disodium) 1 GM Injection before surgery

Other names: antibiotics group

Primary outcomes

  1. surgical complication

    Time frame: 30days

    surgical site infection

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jan 27, 2021
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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