Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy (KSWEET-03)
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|ClinicalTrials.gov Identifier: NCT03802097|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Complication of Surgical Procedure||Drug: No antimicrobial prophylaxis||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomized Controlled Trial About no Antimicrobial Prophylaxis for Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-03)|
|Actual Study Start Date :||December 27, 2018|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Treatment group
No antimicrobial prophylaxis
Drug: No antimicrobial prophylaxis
Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
No Intervention: Control group
- 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.
- Length of hospital stay [ Time Frame: up to 6 months ]From date of operation until the date of hospital discharge
- Incidence of remote non-surgical site infections [ Time Frame: within 30 days after operation ]Any postoperative infectious complications other than surgical site infections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802097
|Contact: Oh Jeong, M.D., Ph.D.||+firstname.lastname@example.org|
|Korea, Republic of|
|Chonnam National University Hwasun Hospital||Recruiting|
|Hwasun, Jellanamdo, Korea, Republic of, 58128|
|Contact: Oh Jeong, M.D., Ph.D.|
|Principal Investigator:||Oh Jeong, M.D.,Ph.D.||Chonnam National University Hospital|