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

Not Applicable

Completed

• Conditions: Acute Cholecystitis
• Interventions: Drug: Cephalosporin; Drug: Placebo

• Registration Number: NCT02490293
• Lead Sponsor: Taeho Hong

Brief 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.

Detailed Description

Primary outcome of this study is the confirmation of safety in the cases of acute cholecystitis without postoperative antibiotics usage after laparoscopic cholecystectomy. For this purpose, the investigators compare the surgical infectious outcomes including the wound infection or abdominal infections according to the usage of postoperative antibiotics after laparoscopic cholecystectomy.

Secondary outcome of this study is the confirmation of efficacy according to skip the use of postoperative antibiotics after laparoscopic cholecystectomy.

The investigators estimate the efficacy using the comparing the outcomes such as duration of hospitalization according to the use of postoperative antibiotics or not.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2016-10-20
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-23
• Last Update Submitted: 2017-02-23
• Results First Posted: 2017-04-07
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• grade I Tokyo guideline for acute cholecystitis
• grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation

Exclusion Criteria

• chronic cholecystitis
• gallbladder polyp or gallbladder cancer
• the patient who underwent reduced port surgery
• the patient who underwent common bile duct exploration during the operation
• the patient who underwent concurrent operation
• the patient who had past history of upper abdominal surgery
• the patient who had a immunodeficiency state
• the case which had a suspicion of delayed bile leakage
• the case which had a incomplete cystic duct ligation
• the patient who underwent open conversion surgery during the operation
• the patient who had a high risk of bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (cephalosporin)	Cephalosporin	During the period of hospitalization, intake of active drug ('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.
Group B (placebo)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Infectious Postoperative Complications	30 days	Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with antibiotics or placebo

Secondary Outcome Measures

Name	Time	Method
Duration of Hospitalization	participants will be followed for the duration of hospital stay, an expected average of 2 days	the duration between the operation day and the day of discharge

Trial Locations

Locations (1)

Seoul St. Mary's hospital; 🇰🇷 Seoul, Seocho-gu, Banopo-dong, Korea, Republic of