No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

NCT02200315 | Completed Phase 2 DMC

• 1 other identifier: KSWEET-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stomach Neoplasms

Keywords

Stomach neoplasms; Surgical site infection; Laparoscopic gastrectomy; Antimicrobial prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative morbidity and mortality

  Within postoperative 1 month or during hospitalization

• Hospital stay

  Up to 1month after operation

Study Arms (1)

No Antimicrobial prophylaxis

EXPERIMENTAL

No use of antimicrobial prophylaxis during surgery

Other: No Antimicrobial prophylaxis

Interventions

No Antimicrobial prophylaxis OTHER

Antimicrobial prophylaxis are not administered during an operation

No Antimicrobial prophylaxis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean South West East Gastric Surgery Group: lead

Study Sites (3)

Chonnam National University Hwasun Hospital

Hwasun-eup, Jeollanam-do, 519-809, South Korea

Location

Dong-A University Hospital

Busan, Kyungsang-do, 602-715, South Korea

Location

Kyemyung University Dongsan Medical Center

Daegu, Kyungsang-do, 700-712, South Korea

Location

Related Publications (13)

• 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.

  PMID: 12584377 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.

  PMID: 18780131 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.

  PMID: 9623456 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.

  PMID: 23327981 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.

  PMID: 15990978 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.

  PMID: 16557434 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.

  PMID: 22350727 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.

  PMID: 18437472 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.

  PMID: 20160637 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.

  PMID: 14973693 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.

  PMID: 14752639 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.

  PMID: 1656747 BACKGROUND

• 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.

  PMID: 28656047 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Officials

• Oh Jeong, MD, PhD

  Chonnam National University Hospital

  STUDY DIRECTOR

• Young Kyu Park, MD, PhD

  Chonnam National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 25, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)