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

NCT02490293 — Not applicable, Completed, 198 participants, Taeho Hong

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

Registry	NCT02490293
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	198 (Actual)
Sponsor	Taeho Hong (Other); collaborators: Incheon St.Mary's Hospital, Bucheon St. Mary's Hospital, Uijeongbu St. Mary Hospital, Catholic University of Korea Saint Paul's Hospital
Conditions	Acute Cholecystitis
Interventions	Cephalosporin, Placebo (Drug)
Dates	start 2015-06-01, primary completion 2016-06-01, completion 2016-06-01, first posted 2015-07-03, last updated 2017-04-07
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group A (cephalosporin)	Experimental	Drug: 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 comparator	Drug: 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.

Cephalosporin (Drug), also known as 'Pacetin': 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 (Drug), also known as normal saline and vitamin C: 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.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Group A (Cephalosporin)	Group B (Placebo)
Started	96	102
Completed	94	99
Not completed	2	3

Outcome results

Number of Participants With Infectious Postoperative Complications (Primary), Count of participants, Participants: Group A (Cephalosporin) 8; Group B (Placebo) 7
Duration of Hospitalization (Secondary), Mean, days: Group A (Cephalosporin) 3.5 +/- 1.1; Group B (Placebo) 3.2 +/- 1.0

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Group A (Cephalosporin)	0	0/93 (0.0%)	14/93 (15.1%)
Group B (Placebo)	0	0/95 (0.0%)	14/95 (14.7%)

Other adverse events by term

Term	Organ system	Group A (Cephalosporin)	Group B (Placebo)
pancreatitis	Gastrointestinal disorders	0/93	3/95
diarrhea	Gastrointestinal disorders	3/93	1/95
CBD stone	Hepatobiliary disorders	3/93	3/95
wound infection	Infections and infestations	8/93	7/95

+Locations (1)

Facility	City	Country	Status
Seoul St. Mary's hospital	Seoul, Seocho-gu, Banopo-dong	South Korea

+Investigators

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

My Notes

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