AzTrials
AzTrials

Stomach NeoplasmsPhase 2KSWEET-01NCT02200315

No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy

A Phase 2 study testing No Antimicrobial prophylaxis in people with Stomach Neoplasms, run by Korean South West East Gastric Surgery Group at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
No Antimicrobial prophylaxis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
3 sitesSouth Korea
Study dates
May 2014to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Dong-A University Hospital

    Busan, Kyungsang-do, 602-715

  • Kyemyung University Dongsan Medical Center

    Daegu, Kyungsang-do, 700-712

  • Chonnam National University Hwasun Hospital

    Hwasun-eup, Jeollanam-do, 519-809

Other trials in South Korea

About this study

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

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.

Read the detailed 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.

Being tested
No Antimicrobial prophylaxis
Keywords
Stomach neoplasms, Surgical site infection, Laparoscopic gastrectomy, Antimicrobial prophylaxis
Medical subject headings
Stomach Neoplasms, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Antimicrobial prophylaxisOther

    Antimicrobial prophylaxis are not administered during an operation

Study groups in NCT02200315
Study groupRoleWhat they receive
No Antimicrobial prophylaxisExperimentalNo use of antimicrobial prophylaxis during surgery
Receives: Other: No Antimicrobial prophylaxis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative surgical site infection

    Incidence of surgical site infection, including superficial incisional, deep incisional, and organ/space infection, until postoperative 1 month

    Measured: Within postoperative 1 month

Secondary outcomes (2)

  1. 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.

    Measured: Within postoperative 1 month or during hospitalization

  2. Hospital stay

    The duration of hospital stay from the operation to hospital discharge

    Measured: Up to 1month after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJun 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02200315
Sponsor's protocol ID
KSWEET-01
Acronym
KSWEET-01
Status last verified
Feb 2016
First submitted
21 Jul 2014
Last updated
3 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 12584377

  • 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.

    PubMed 18780131

  • 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.

    PubMed 9623456

  • 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.

    PubMed 23327981

  • 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.

    PubMed 15990978

  • 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.

    PubMed 16557434

  • 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.

    PubMed 22350727

  • 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.

    PubMed 18437472

  • 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.

    PubMed 20160637

  • 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.

    PubMed 14973693

  • 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.

    PubMed 14752639

  • 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.

    PubMed 1656747

  • 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.

    PubMed 28656047

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing No Antimicrobial prophylaxis in people with Stomach Neoplasms, run by Korean South West East Gastric Surgery Group at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative surgical site infection (time frame: Within postoperative 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200315, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in