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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Antimicrobial prophylaxis | Experimental | No use of antimicrobial prophylaxis during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Antimicrobial prophylaxis | Other | Antimicrobial prophylaxis are not administered during an operation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oh Jeong, MD, PhD | Chonnam National University Hospital | Study Director |
| Young Kyu Park, MD, PhD | Chonnam National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun-eup | Jeollanam-do | 519-809 | South Korea | ||
| Dong-A University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12584377 | Background | Burke 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. | |
| 18780131 | Background | Choudhary 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. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The duration of hospital stay from the operation to hospital discharge |
| Up to 1month after operation |
| Busan |
| Kyungsang-do |
| 602-715 |
| South Korea |
| Kyemyung University Dongsan Medical Center | Daegu | Kyungsang-do | 700-712 | South Korea |
| 9623456 | Background | McDonald 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. |
| 23327981 | Background | Bratzler 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. |
| 15990978 | Background | Imai 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. |
| 16557434 | Background | Imamura 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. |
| 22350727 | Background | Migita 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. |
| 18437472 | Background | Memon MA, Khan S, Yunus RM, Barr R, Memon B. Meta-analysis of laparoscopic and open distal gastrectomy for gastric carcinoma. Surg Endosc. 2008 Aug;22(8):1781-9. doi: 10.1007/s00464-008-9925-9. Epub 2008 Apr 25. |
| 20160637 | Background | Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b. |
| 14973693 | Background | Ammori BJ. A prospective randomized study of prophylactic antibiotics in elective laparoscopic cholecystectomy. Surg Endosc. 2004 Mar;18(3):565; author reply 566. doi: 10.1007/s00464-003-9141-6. Epub 2004 Feb 2. No abstract available. |
| 14752639 | Background | Catarci M, Mancini S, Gentileschi P, Camplone C, Sileri P, Grassi GB. Antibiotic prophylaxis in elective laparoscopic cholecystectomy. Lack of need or lack of evidence? Surg Endosc. 2004 Apr;18(4):638-41. doi: 10.1007/s00464-003-9090-0. Epub 2004 Feb 2. |
| 1656747 | Background | Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z. |
| 28656047 | Derived | Jeong O, Jung MR, Ryu SY, Park YK, Kim MC, Kim KH, Ryu SW, Kwon IG, Son YG. Multicenter Phase 2 Study about the Safety of No Antimicrobial Prophylaxis Use in Low-Risk Patients Undergoing Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-01 Study). Gastroenterol Res Pract. 2017;2017:8928353. doi: 10.1155/2017/8928353. Epub 2017 Jun 5. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |