Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?
Primary Purpose
Acute Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cephalosporin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis
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
Sites / Locations
- Seoul St. Mary's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A (cephalosporin)
Group B (placebo)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of Hospitalization
the duration between the operation day and the day of discharge
Full Information
NCT ID
NCT02490293
First Posted
June 15, 2015
Last Updated
February 23, 2017
Sponsor
Taeho Hong
Collaborators
Incheon St.Mary's Hospital, Bucheon St. Mary's Hospital, Uijeongbu St. Mary Hospital, Catholic University of Korea Saint Paul's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02490293
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taeho Hong
Collaborators
Incheon St.Mary's Hospital, Bucheon St. Mary's Hospital, Uijeongbu St. Mary Hospital, Catholic University of Korea Saint Paul's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (cephalosporin)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (placebo)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cephalosporin
Other Intervention Name(s)
'Pacetin'
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline and vitamin C
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Infectious Postoperative Complications
Description
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
Secondary Outcome Measure Information:
Title
Duration of Hospitalization
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taeho Hong
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's hospital
City
Seoul
State/Province
Seocho-gu, Banopo-dong
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?
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