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

• Sponsor: Taeho Hong (Other)
• Overall Status: Completed
• CT.gov ID: NCT02490293
• Collaborator: Incheon St.Mary's Hospital (Other), Bucheon St. Mary's Hospital (Other), Uijeongbu St. Mary Hospital (Other), Catholic University of Korea Saint Paul's Hospital (Other)
• Enrollment: 198
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis	Drug: Cephalosporin; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?; a Multicenter Randomized Controlled Trial
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.; Other Names: 'Pacetin'
Placebo Comparator: 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.	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.; Other Names: normal saline and vitamin C

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St. Mary's hospital	Seoul	Seocho-gu, Banopo-dong	Korea, Republic of	137-701

Sponsors and Collaborators

• Taeho Hong
• Incheon St.Mary's Hospital
• Bucheon St. Mary's Hospital
• Uijeongbu St. Mary Hospital
• Catholic University of Korea Saint Paul's Hospital

Investigators

• Principal Investigator: Taeho Hong, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taeho Hong, Professor, Seoul St. Mary's Hospital
• ClinicalTrials.gov Identifier: NCT02490293
• Other Study ID Numbers: Seoul-05
• First Posted: Jul 3, 2015
• Last Update Posted: Apr 7, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Cholecystitis; Cholecystitis, Acute; Cephalosporins

Study Results

Participant Flow

Arm/Group Title	Group A (Cephalosporin)	Group B (Placebo)
Arm/Group 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. 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.	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.
Period Title: Overall Study
STARTED	96	102
COMPLETED	94	99
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Group A (Cephalosporin)	Group B (Placebo)	Total
Arm/Group 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. 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.	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 of all reporting groups
Overall Participants	93	95	188
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	83 89.2%	85 89.5%	168 89.4%
>=65 years	10 10.8%	10 10.5%	20 10.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (15.3)	52.0 (15.0)	52.0 (15.1)
Sex: Female, Male (Count of Participants)
Female	44 47.3%	49 51.6%	93 49.5%
Male	49 52.7%	46 48.4%	95 50.5%
Region of Enrollment (participants) [Number]
Korea, Republic of	93 100%	95 100%	188 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A (Cephalosporin)	Group B (Placebo)
Arm/Group 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. 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.	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.
Measure Participants	93	95
Count of Participants [Participants]	8 8.6%	7 7.4%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A (Cephalosporin)	Group B (Placebo)
Arm/Group 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. 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.	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.
Measure Participants	93	95
Mean (Standard Deviation) [days]	3.5 (1.1)	3.2 (1.0)

Adverse Events

Arm/Group Title	Group A (Cephalosporin)		Group B (Placebo)
Arm/Group 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. 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.		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.
All Cause Mortality
	Group A (Cephalosporin)		Group B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group A (Cephalosporin)		Group B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/93 (0%)		0/95 (0%)
Other (Not Including Serious) Adverse Events
	Group A (Cephalosporin)		Group B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/93 (15.1%)		14/95 (14.7%)
Gastrointestinal disorders
pancreatitis	0/93 (0%)		3/95 (3.2%)
diarrhea	3/93 (3.2%)		1/95 (1.1%)
Hepatobiliary disorders
CBD stone	3/93 (3.2%)		3/95 (3.2%)
Infections and infestations
wound infection	8/93 (8.6%)		7/95 (7.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.