Acute Cholecystitis
Conditions
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.
Interventions
DRUGCephalosporin
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.
DRUGPlacebo
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.
Sponsors
Incheon St.Mary's Hospital
Bucheon St. Mary's Hospital
Uijeongbu St. Mary Hospital
Catholic University of Korea Saint Paul's Hospital
Taeho Hong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 93 |
| 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. | 95 |
| Total | 188 |
Baseline characteristics
| Characteristic | Group B (Placebo) | Group A (Cephalosporin) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 83 Participants | 168 Participants |
| Age, Continuous | 52.0 years STANDARD_DEVIATION 15 | 52.1 years STANDARD_DEVIATION 15.3 | 52.0 years STANDARD_DEVIATION 15.1 |
| Region of Enrollment Korea, Republic of | 95 participants | 93 participants | 188 participants |
| Sex: Female, Male Female | 49 Participants | 44 Participants | 93 Participants |
| Sex: Female, Male Male | 46 Participants | 49 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 93 | 14 / 95 |
| serious Total, serious adverse events | 0 / 93 | 0 / 95 |
Outcome results
Primary
Number of Participants With 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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A (Cephalosporin) | Number of Participants With Infectious Postoperative Complications | 8 Participants |
| Group B (Placebo) | Number of Participants With Infectious Postoperative Complications | 7 Participants |
Secondary
Duration of Hospitalization
the duration between the operation day and the day of discharge
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (Cephalosporin) | Duration of Hospitalization | 3.5 days | Standard Deviation 1.1 |
| Group B (Placebo) | Duration of Hospitalization | 3.2 days | Standard Deviation 1 |