NCT02200315

No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

Phase II Study of the Efficacy of no Antimicrobial Prophylaxis Use for Laparoscopic Distal Gastrectomy for Gastric Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Korean South West East Gastric Surgery Group · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
OTHER	No Antimicrobial prophylaxis	Antimicrobial prophylaxis are not administered during an operation

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2014-07-25
• Last updated: 2016-02-03

Locations

3 sites across 1 country: South Korea