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