Clinical trial · Interventional
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
NCT02200315CI-TRIAL-00020769KSWEET-01completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Antimicrobial prophylaxis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- No Antimicrobial prophylaxis
- description
- No use of antimicrobial prophylaxis during surgery
- interventionNames
- Other: No Antimicrobial prophylaxis
Primary outcomes (1)
- measure
- Postoperative surgical site infection
- timeFrame
- Within postoperative 1 month
- description
- Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month
Secondary outcomes (2)
- measure
- Postoperative morbidity and mortality
- timeFrame
- Within postoperative 1 month or during hospitalization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDBurke JP. Infection control - a problem for patient safety. N Engl J Med. 2003 Feb 13;348(7):651-6. doi: 10.1056/NEJMhpr020557. No abstract available. PMID 12584377
- BACKGROUNDChoudhary A, Bechtold ML, Puli SR, Othman MO, Roy PK. Role of prophylactic antibiotics in laparoscopic cholecystectomy: a meta-analysis. J Gastrointest Surg. 2008 Nov;12(11):1847-53; discussion 1853. doi: 10.1007/s11605-008-0681-x. Epub 2008 Sep 9. PMID 18780131
- BACKGROUNDMcDonald M, Grabsch E, Marshall C, Forbes A. Single- versus multiple-dose antimicrobial prophylaxis for major surgery: a systematic review. Aust N Z J Surg. 1998 Jun;68(6):388-96. doi: 10.1111/j.1445-2197.1998.tb04785.x. PMID 9623456
- BACKGROUNDBratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available. PMID 23327981
- BACKGROUNDImai E, Ueda M, Kanao K, Miyaki K, Kubota T, Kitajima M. Surgical site infection surveillance after open gastrectomy and risk factors for surgical site infection. J Infect Chemother. 2005 Jun;11(3):141-5. doi: 10.1007/s10156-005-0379-x. PMID 15990978
- BACKGROUNDImamura H, Furukawa H, Iijima S, Sugihara S, Tsujinaka T, Tsukuma H, Shimokawa T. Multicenter phase II study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer. Gastric Cancer. 2006;9(1):32-5. doi: 10.1007/s10120-005-0354-3. PMID 16557434
- BACKGROUNDMigita K, Takayama T, Matsumoto S, Wakatsuki K, Enomoto K, Tanaka T, Ito M, Nakajima Y. Risk factors for surgical site infections after elective gastrectomy. J Gastrointest Surg. 2012 Jun;16(6):1107-15. doi: 10.1007/s11605-012-1838-1. Epub 2012 Feb 15.