Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy
NCT ID: NCT03802097
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
260 participants
INTERVENTIONAL
2018-12-27
2022-03-25
Brief Summary
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Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy without prophylactic antibiotics, specially reference to the postoperative infectious complications.
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Detailed Description
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The primary endpoint is the incidence of surgical site infections within 30 days after surgery and the difference limit of the non-inferiority of the experimental group is assumed to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in the control group is 5% and the incidence of infectious complications in the experimental group is assumed to be about 8%. It is assumed that the significant level is 5% and the power is at least 80%.
According to the above method, a total of 260 patients (130 patients in each group) are needed when 117 patients are needed in each group and about 10% of drop rates and protocol violence are considered.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A group (treatment group)
No use of antimicrobial prophylaxis
No use of antimicrobial prophylaxis
Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
B group (control group)
Use of antimicrobial prophylaxis
Use of antimicrobial prophylaxis
Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
Interventions
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No use of antimicrobial prophylaxis
Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
Use of antimicrobial prophylaxis
Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Korean South West East Gastric Surgery Group
OTHER
Responsible Party
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Oh Jeong
MD, PhD, FACS
Principal Investigators
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Oh Jeong, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Locations
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Chonnam National University Hwasun Hospital
Hwasun, Jellanamdo, South Korea
Countries
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Other Identifiers
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KSWEET-03
Identifier Type: -
Identifier Source: org_study_id
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