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

Acute Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02490293
• Other study ID #: Seoul-05
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 15, 2015
• Last updated: June 15, 2016
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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 the postoperative pain, duration of hospitalization, the postoperative morbidity, the rate of readmission and the rate of reintervention according to the use of postoperative antibiotics or not.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 198
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's hospital	Seoul	Seocho-gu, Banopo-dong

Sponsors (5)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Bucheon St. Mary's Hospital, Catholic University of Korea Saint Paul's Hospital, Incheon St.Mary's Hospital, Uijeongbu St. Mary Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infectious postoperative complications	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	30 days	No
Secondary	Duration of hospitalization	the duration between the operation day and the day of discharge	participants will be followed for the duration of hospital stay, an expected average of 2 days	No