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

NCT02490293 | Completed Results

• 1 other identifier: Seoul-05
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (1)

• Duration of Hospitalization

  participants will be followed for the duration of hospital stay, an expected average of 2 days

Study Arms (2)

Group A (cephalosporin)

EXPERIMENTAL

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

Group B (placebo)

PLACEBO COMPARATOR

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

Interventions

Cephalosporin DRUG

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.

Also known as: 'Pacetin'

Group A (cephalosporin)

Placebo DRUG

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.

Also known as: normal saline and vitamin C

Group B (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• grade I Tokyo guideline for acute cholecystitis
• grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cephalosporins; Saline Solution; Ascorbic Acid

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Tae-ho Hong
• Organization: SeoulStmary's hospital

gshth@catholic.ac.kr

010-5206-5266

Study Officials

• Taeho Hong

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 3, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-02

Locations

KR (1)