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Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?

NCT02490293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2017-04-07

Study results available
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Summary

During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use the postoperative antibiotics after surgery. However, there is no consensus regarding the actual need of postoperative antibiotics in these cases and the use of postoperative antibiotics remains controversial.

Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the patients who has no evidence of systemic infection, according to the usage of postoperative antibiotics or not. The investigators expect that the routine use of postoperative antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have no effects on the postoperative morbidity.

Conditions

  • Acute Cholecystitis

Interventions

DRUG

Cephalosporin

During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge. After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.

DRUG

Placebo

During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge. After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.

Sponsors & Collaborators

  • Incheon St.Mary's Hospital

    collaborator OTHER

  • Bucheon St. Mary's Hospital

    collaborator OTHER

  • Uijeongbu St. Mary Hospital

    collaborator OTHER

  • Catholic University of Korea Saint Paul's Hospital

    collaborator OTHER

  • Taeho Hong

    lead OTHER

Principal Investigators

  • Taeho Hong · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02490293 on ClinicalTrials.gov