No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy
Conditions
Stomach Neoplasms
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Stomach neoplasms, Surgical site infection, Laparoscopic gastrectomy, Antimicrobial prophylaxis
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Laparoscopic Distal Gastrectomy
Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Chonnam National University Hwasun Hospital
Hwasun-eup, Jeollanam-do, Korea, Republic of
Status: Recruiting
Dong-A University Hospital
Busan, Kyungsang-do, Korea, Republic of
Status: Recruiting
Kyemyung University Dongsan Medical Center
Daegu, Kyungsang-do, Korea, Republic of
Status: Recruiting
Start Date
May 2014
Completion Date
July 2015
Sponsors
Korean South West East Gastric Surgery Group
Source
Korean South West East Gastric Surgery Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page