Clinical trial NCT02200315: No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy
Official title: Phase II Study of the Efficacy of no Antimicrobial Prophylaxis Use for Laparoscopic Distal Gastrectomy for Gastric Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: Stomach neoplasms
Surgical site infection
Laparoscopic gastrectomy
Antimicrobial prophylaxis
Lead sponsor: Korean South West East Gastric Surgery Group
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative surgical site infection
timeFrame: Within postoperative 1 month
Secondary outcomes:
measure: Postoperative morbidity and mortality
timeFrame: Within postoperative 1 month or during hospitalization
measure: Hospital stay
timeFrame: Up to 1month after operation
Other outcomes:
Locations:
city: Hwasun-eup
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Kyungsang-do
city: Daegu
country: Korea, Republic of
facility: Kyemyung University Dongsan Medical Center
state: Kyungsang-do
Study officials:
affiliation: Chonnam National University Hospital
name: Oh Jeong, MD, PhD
role: STUDY_DIRECTOR
affiliation: Chonnam National University Hospital
name: Young Kyu Park, MD, PhD
role: STUDY_CHAIR
References:
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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. doi: 10.1016/0002-9343(91)90361-z.
citation: 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.