No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

Stomach Neoplasms Clinical Trial

— KSWEET-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200315
• Other study ID #: KSWEET-01
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2014
• Last updated: February 1, 2016
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Korean South West East Gastric Surgery Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Other:
• No Antimicrobial prophylaxis
Antimicrobial prophylaxis are not administered during an operation

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan	Kyungsang-do
Korea, Republic of	Kyemyung University Dongsan Medical Center	Daegu	Kyungsang-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-eup	Jeollanam-do

Sponsors (1)

Lead Sponsor	Collaborator
Korean South West East Gastric Surgery Group

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

Ammori BJ. A prospective randomized study of prophylactic antibiotics in elective laparoscopic cholecystectomy. Surg Endosc. 2004 Mar;18(3):565; author reply 566. Epub 2004 Feb 2. — View Citation

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. — View Citation

Burke JP. Infection control - a problem for patient safety. N Engl J Med. 2003 Feb 13;348(7):651-6. — View Citation

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. Epub 2004 Feb 2. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: J Infect Chemother. 2006 Feb;12(1):51. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Hospital stay	The duration of hospital stay from the operation to hospital discharge	Up to 1month after operation	No