No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

Phase 2

Completed

• Conditions: Stomach Neoplasms
• Interventions: Other: No Antimicrobial prophylaxis

• Registration Number: NCT02200315
• Lead Sponsor: Korean South West East Gastric Surgery Group

Brief 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Primary Completion: 2015-06
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No Antimicrobial prophylaxis	No Antimicrobial prophylaxis	No use of antimicrobial prophylaxis during surgery

Primary Outcome Measures

Name	Time	Method
Postoperative surgical site infection	Within postoperative 1 month	Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month

Secondary Outcome Measures

Name	Time	Method
Postoperative morbidity and mortality	Within postoperative 1 month or during hospitalization	Occurence of postoperative complications or deaths until postoperative 1 months or during hospitalization. Postoperative complications will be assessed with respect to types and severity.
Hospital stay	Up to 1month after operation	The duration of hospital stay from the operation to hospital discharge

Trial Locations

Locations (3)

Kyemyung University Dongsan Medical Center; 🇰🇷 Daegu, Kyungsang-do, Korea, Republic of

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun-eup, Jeollanam-do, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Kyungsang-do, Korea, Republic of