Trial Outcomes & Findings for Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder? (NCT NCT02490293)
NCT ID: NCT02490293
Last Updated: 2017-04-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
198 participants
Primary outcome timeframe
30 days
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Group A (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.
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.
|
Group B (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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
102
|
|
Overall Study
COMPLETED
|
94
|
99
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?
Baseline characteristics by cohort
| Measure |
Group A (Cephalosporin)
n=93 Participants
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.
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.
|
Group B (Placebo)
n=95 Participants
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.
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.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 15.3 • n=99 Participants
|
52.0 years
STANDARD_DEVIATION 15.0 • n=107 Participants
|
52.0 years
STANDARD_DEVIATION 15.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
93 participants
n=99 Participants
|
95 participants
n=107 Participants
|
188 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysIncidence 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
Outcome measures
| Measure |
Group A (Cephalosporin)
n=93 Participants
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.
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.
|
Group B (Placebo)
n=95 Participants
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.
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.
|
|---|---|---|
|
Number of Participants With Infectious Postoperative Complications
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 2 daysthe duration between the operation day and the day of discharge
Outcome measures
| Measure |
Group A (Cephalosporin)
n=93 Participants
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.
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.
|
Group B (Placebo)
n=95 Participants
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.
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.
|
|---|---|---|
|
Duration of Hospitalization
|
3.5 days
Standard Deviation 1.1
|
3.2 days
Standard Deviation 1.0
|
Adverse Events
Group A (Cephalosporin)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Group B (Placebo)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A (Cephalosporin)
n=93 participants at risk
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.
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.
|
Group B (Placebo)
n=95 participants at risk
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.
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.
|
|---|---|---|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/93
|
3.2%
3/95
|
|
Gastrointestinal disorders
diarrhea
|
3.2%
3/93
|
1.1%
1/95
|
|
Hepatobiliary disorders
CBD stone
|
3.2%
3/93
|
3.2%
3/95
|
|
Infections and infestations
wound infection
|
8.6%
8/93
|
7.4%
7/95
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place