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Completed

NCT Number: NCT02200315

No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Infections Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Stomach Diseases Surgical Wound Infection Wound Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam National University Hwasun Hospital, Hwasun-eup, Jeollanam-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Antimicrobial prophylaxis

Other

Antimicrobial prophylaxis are not administered during an operation

Primary outcomes

  1. Postoperative surgical site infection

    Time frame: Within postoperative 1 month

    Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month

Secondary outcomes

  1. Postoperative morbidity and mortality

    Time frame: 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.

  2. Hospital stay

    Time frame: Up to 1month after operation

    The duration of hospital stay from the operation to hospital discharge

Sponsors and collaborators

Lead sponsor

Korean South West East Gastric Surgery Group

Other

Registry information

Official study title

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

Acronym: KSWEET-01

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2014
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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