N/A
N=198
Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?
Acute Cholecystitis
Bottom Line
View on ClinicalTrials.gov: NCT02490293 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Infectious Postoperative Complications — 8; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cephalosporin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Taeho Hong
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Infectious Postoperative Complications |
8; 7 | — |
| SECONDARY Duration of Hospitalization |
3.5; 3.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02490293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.