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Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy (KSWEET-03)

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ClinicalTrials.gov Identifier: NCT03802097
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Oh Jeong, Korean South West East Gastric Surgery Group

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 surgical techniques and improvement of prevention and control of surgical infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not significantly higher than previously reported data.

Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy without prophylactic antibiotics, specially reference to the postoperative infectious complications.


Condition or disease Intervention/treatment Phase
Gastric Cancer Complication of Surgical Procedure Drug: No antimicrobial prophylaxis Phase 3

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 group using prophylactic antibiotics.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
No antimicrobial prophylaxis
Drug: No 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

No Intervention: Control group
Antimicrobial prophylaxis



Primary Outcome Measures :
  1. Incidence of surgical site infections within 30 days [ Time Frame: within 30 days after operation ]
    The diagnosis of infectious complications is made according to the Centers for Disease Control and Prevention (CDC) surgical site infection diagnosis criteria according to physical or radiological findings.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: up to 6 months ]
    From date of operation until the date of hospital discharge

  2. Incidence of remote non-surgical site infections [ Time Frame: within 30 days after operation ]
    Any postoperative infectious complications other than surgical site infections



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802097


Contacts
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Contact: Oh Jeong, M.D., Ph.D. +82-61-379-7648 surgeonjeong@gmail.com

Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jellanamdo, Korea, Republic of, 58128
Contact: Oh Jeong, M.D., Ph.D.         
Sponsors and Collaborators
Korean South West East Gastric Surgery Group
Investigators
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Principal Investigator: Oh Jeong, M.D.,Ph.D. Chonnam National University Hospital

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Responsible Party: Oh Jeong, MD, PhD, FACS, Korean South West East Gastric Surgery Group
ClinicalTrials.gov Identifier: NCT03802097     History of Changes
Other Study ID Numbers: KSWEET-03
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oh Jeong, Korean South West East Gastric Surgery Group:
Gastric cancer
Laparoscopic gastrectomy
Prophylactic antibiotics
Infectious complications

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Anti-Infective Agents
Anti-Bacterial Agents