Gastric CancerKSWEET-03NCT03802097
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy
A study testing No use of antimicrobial prophylaxis and Use of antimicrobial prophylaxis in people with Gastric Cancer and Complication of Surgical Procedure, run by Korean South West East Gastric Surgery Group at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Complication of Surgical Procedure
- What is being tested?
- No use of antimicrobial prophylaxis and Use of antimicrobial prophylaxis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2018to 25 Mar 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hwasun Hospital
Hwasun, Jellanamdo, 58128
About this study
Official title: Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)
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.
Read the detailed description
The purpose of this study was to investigate the non-inferiority of incidence of infectious complications in the experimental group that did not use prophylactic antibiotics compared to the control group using prophylactic antibiotics.
The primary endpoint is the incidence of surgical site infections within 30 days after surgery and the difference limit of the non-inferiority of the experimental group is assumed to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in the control group is 5% and the incidence of infectious complications in the experimental group is assumed to be about 8%. It is assumed that the significant level is 5% and the power is at least 80%.
According to the above method, a total of 260 patients (130 patients in each group) are needed when 117 patients are needed in each group and about 10% of drop rates and protocol violence are considered.
- Conditions
- Gastric Cancer, Complication of Surgical Procedure
- Being tested
- No use of antimicrobial prophylaxis, Use of antimicrobial prophylaxis
- Keywords
- Gastric cancer, Laparoscopic gastrectomy, Prophylactic antibiotics, Infectious complications
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No use of antimicrobial prophylaxisProcedure or surgery
Also called No AMP
Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
Use of antimicrobial prophylaxisProcedure or surgery
Also called AMP
Use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| A group (treatment group) | Experimental | No use of antimicrobial prophylaxis Receives: Procedure: No use of antimicrobial prophylaxis |
| B group (control group) | Experimental | Use of antimicrobial prophylaxis Receives: Procedure: Use of antimicrobial prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days after operation
Secondary outcomes (2)
Length of hospital stay
From date of operation until the date of hospital discharge
Measured: up to 6 months
Incidence of remote non-surgical site infections
Any postoperative infectious complications other than surgical site infections
Measured: within 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start27 Dec 2018
- Primary completion31 Jan 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean South West East Gastric Surgery Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oh Jeong, Korean South West East Gastric Surgery Group
- Investigators
- Oh Jeong, M.D.,Ph.D., Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802097
- Sponsor's protocol ID
- KSWEET-03
- Acronym
- KSWEET-03
- Status last verified
- Mar 2022
- First submitted
- 7 Jan 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)
- ClinicalTrials.gov ID
- NCT03802097
- Acronym / sponsor ID
- KSWEET-03 / KSWEET-03
- Conditions
- Gastric Cancer, Complication of Surgical Procedure
- Keywords
- Gastric cancer, Laparoscopic gastrectomy, Prophylactic antibiotics, Infectious complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Korean South West East Gastric Surgery GroupUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study was to investigate the non-inferiority of incidence of infectious complications in the experimental group that did not use prophylactic antibiotics compared to the control group using prophylactic antibiotics.
The primary endpoint is the incidence of surgical site infections within 30 days after surgery and the difference limit of the non-inferiority of the experimental group is assumed to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in the control group is 5% and the incidence of infectious complications in the experimental group is assumed to be about 8%. It is assumed that the significant level is 5% and the power is at least 80%.
According to the above method, a total of 260 patients (130 patients in each group) are needed when 117 patients are needed in each group and about 10% of drop rates and protocol violence are considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group (treatment group) | Experimental | Procedure: No use of antimicrobial prophylaxisNo use of antimicrobial prophylaxis |
| B group (control group) | Experimental | Procedure: Use of antimicrobial prophylaxisUse of antimicrobial prophylaxis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No use of antimicrobial prophylaxisAlso: No AMPDo not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer | Procedure or surgery | A group (treatment group) |
| Use of antimicrobial prophylaxisAlso: AMPUse of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer | Procedure or surgery | B group (control group) |
Primary outcome
Incidence of surgical site infections within 30 days
Time frame: within 30 days after operation
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.
2 secondary outcomes
Length of hospital stay
Time frame: up to 6 months
Incidence of remote non-surgical site infections
Time frame: within 30 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Jeong, M.D.,Ph.D. principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No use of antimicrobial prophylaxis and Use of antimicrobial prophylaxis in people with Gastric Cancer and Complication of Surgical Procedure, run by Korean South West East Gastric Surgery Group at 1 site 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 7 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Incidence of surgical site infections within 30 days (time frame: within 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.