Clinical trial NCT02490293: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Incheon St.Mary's Hospital
name: Bucheon St. Mary's Hospital
name: Uijeongbu St. Mary Hospital
name: Catholic University of Korea Saint Paul's Hospital
First posted: 2015-07-03
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Infectious Postoperative Complications
timeFrame: 30 days
Secondary outcomes:
measure: Duration of Hospitalization
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
state: Seocho-gu, Banopo-dong
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Taeho Hong
role: PRINCIPAL_INVESTIGATOR
References: