No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy (KSWEET-01)

Korean South West East Gastric Surgery Group

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Other: No Antimicrobial prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT02200315

KSWEET-01

Details and patient eligibility

About

The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.

Full description

This is a phase II clinical trial investigating the postoperative surgical site infection (SSI) rates after no antimicrobial prophylaxis use during laparoscopic distal gastrectomy. Target ranges of SSI rates after laparoscopic distal gastrectomy were determined based on the previous reports and our data. If SSI rates are within the target range, the investigators will proceed to a randomized controlled trial investigating the efficacy of no antimicrobial use for laparoscopic gastrectomy.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven gastric adenocarcinoma clinical stage T1-2N0M0 patients who underwent laparoscopic distal gastrectomy
• Age between 18 and 65 years
• American Society of Anaesthesiologists (ASA) status >2
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Normal blood, liver, pulmonary, cardiac, and renal function
• Informed consent

Exclusion criteria

• Administration of antibiotics within 1 month before surgery
• Active infection at the time of surgery
• Combined resection during operation (i.e., spleen, liver, colon, etc.)
• History of upper abdominal surgery
• Previous chemotherapy or radiotherapy within 6 months before surgery
• Uncontrolled underlying comorbidities
• Malnutrition with BMI less than 18.5 kg/m2

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

No Antimicrobial prophylaxis

Experimental group

Description:

No use of antimicrobial prophylaxis during surgery

Treatment:

Other: No Antimicrobial prophylaxis