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

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Brief Title

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

Official Title

Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?; a Multicenter Randomized Controlled Trial

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 Type

Interventional


Primary Outcome

Number of Participants With Infectious Postoperative Complications

Secondary Outcome

 Duration of Hospitalization

Condition

Acute Cholecystitis

Intervention

Cephalosporin

Study Arms / Comparison Groups

 Group A (cephalosporin)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

198

Start Date

June 2015

Completion Date

June 2016

Primary Completion Date

June 2016

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Taeho Hong, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02490293

Organization ID

Seoul-05


Responsible Party

Sponsor-Investigator

Study Sponsor

Taeho Hong

Collaborators

 Incheon St.Mary's Hospital

Study Sponsor

Taeho Hong, Principal Investigator, Seoul St. Mary's Hospital


Verification Date

February 2017