Status:
COMPLETED
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy
Lead Sponsor:
Korean South West East Gastric Surgery Group
Conditions:
Gastric Cancer
Complication of Surgical Procedure
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Laparoscopic gastrectomy has fewer infectious complications compared to open surgery. Recently, the incidence of postoperative infectious complications was greatly reduced due to the development of su...
Detailed Description
The purpose of this study was to investigate the non-inferiority of incidence of infectious complications in the experimental group that did not use prophylactic antibiotics compared to the control gr...
Eligibility Criteria
Inclusion
- A patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer located in the low or middle part of the stomach
- A patient who underwent limited lymphadenectomy (D1 or D1+) with clinical T1-2N0M0 stage based on 8th edition of the International Union Against Cancer (UICC) tumor node metastasis (TNM) classification
- From 18 to 75 years old
- Eastern Cooperative Oncology Group (ECOG) status 0-1
- American Society of Anesthesiologists (ASA) score I-II
- A patient with appropriate bone marrow function, renal function, lung function, and liver function
- Before the surgery, decide to participate in this study and agree with the written informed consent
Exclusion
- A patient who underwent previous abdominal surgery
- Combined other abdominal organ cancer
- A patient who received chemotherapy and radiotherapy within the last 6 months
- Combined organ resection other than cholecystectomy
- A patient undergoing emergency surgery due to perforation or bleeding
- A patient who have received antibiotic treatment for other infectious diseases within one month of operation
- Severely malnourished patient
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03802097
Start Date
December 27 2018
End Date
March 25 2022
Last Update
April 6 2022
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun, Jellanamdo, South Korea, 58128