NCT03802097

Brief Summary

Laparoscopic gastrectomy has fewer infectious complications compared to open surgery. Recently, the incidence of postoperative infectious complications was greatly reduced due to the development of surgical techniques and improvement of prevention and control of surgical infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not significantly higher than previously reported data. Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy without prophylactic antibiotics, specially reference to the postoperative infectious complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

January 7, 2019

Last Update Submit

March 28, 2022

Conditions

Gastric CancerComplication of Surgical Procedure

Keywords

Gastric cancerLaparoscopic gastrectomyProphylactic antibioticsInfectious complications

Outcome Measures

Primary Outcomes (1)

  • Incidence of surgical site infections within 30 days

    The diagnosis of infectious complications is made according to the Centers for Disease Control and Prevention (CDC) surgical site infection diagnosis criteria according to physical or radiological findings.

    within 30 days after operation

Secondary Outcomes (2)

  • Length of hospital stay

    up to 6 months

  • Incidence of remote non-surgical site infections

    within 30 days after operation

Study Arms (2)

A group (treatment group)

EXPERIMENTAL

No use of antimicrobial prophylaxis

Procedure: No use of antimicrobial prophylaxis

B group (control group)

EXPERIMENTAL

Use of antimicrobial prophylaxis

Procedure: Use of antimicrobial prophylaxis

Interventions

No use of antimicrobial prophylaxisPROCEDURE

Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

Also known as: No AMP
A group (treatment group)
Use of antimicrobial prophylaxisPROCEDURE

Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer

Also known as: AMP
B group (control group)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer located in the low or middle part of the stomach
  • A patient who underwent limited lymphadenectomy (D1 or D1+) with clinical T1-2N0M0 stage based on 8th edition of the International Union Against Cancer (UICC) tumor node metastasis (TNM) classification
  • From 18 to 75 years old
  • Eastern Cooperative Oncology Group (ECOG) status 0-1
  • American Society of Anesthesiologists (ASA) score I-II
  • A patient with appropriate bone marrow function, renal function, lung function, and liver function
  • Before the surgery, decide to participate in this study and agree with the written informed consent

You may not qualify if:

  • A patient who underwent previous abdominal surgery
  • Combined other abdominal organ cancer
  • A patient who received chemotherapy and radiotherapy within the last 6 months
  • Combined organ resection other than cholecystectomy
  • A patient undergoing emergency surgery due to perforation or bleeding
  • A patient who have received antibiotic treatment for other infectious diseases within one month of operation
  • Severely malnourished patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jellanamdo, 58128, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Adenosine Monophosphate

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Oh Jeong, M.D.,Ph.D.

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FACS

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 14, 2019

Study Start

December 27, 2018

Primary Completion

January 31, 2022

Study Completion

March 25, 2022

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)