No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Other: No Antimicrobial prophylaxis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No Antimicrobial prophylaxis<br>No use of antimicrobial prophylaxis during surgery | Other: No Antimicrobial prophylaxis<br>* Antimicrobial prophylaxis are not administered during an operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative surgical site infection | Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month | Within postoperative 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach neoplasms, Surgical site infection, Laparoscopic gastrectomy, Antimicrobial prophylaxis