UMIN ID: UMIN000001062
Registered date:03/03/2008
Randomized clinical trial about the period of antimicrobial prophylaxis administration in total gastrectomy for gastric cancer.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Gastric cancer patients undergoing elective total gastrectomy |
| Date of first enrollment | 2008/03/01 |
| Target sample size | 460 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Ampicillin-sulbactam is administered after the induction of anesthesia, and the patients received an additional dose if the operation was prolonged beyond 3 hour, and Ampicillin-sulbactam was administered again twice daily for 3 consecutive days after the operation Ampicillin-sulbactam is administered after the induction of anesthesia, and the patients received an additional dose if the operation was prolonged beyond 3 hour, and Ampicillin-sulbactam was administered at 6 hour and 18hour at end of the operation. |
Outcome(s)
| Primary Outcome | The primary outcome is to show that a 24 hours antibiotic administration of the end of the operation was not inferior to the 3 days antibiotic administration of the postoperative period. |
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| Secondary Outcome | The secondary outcome is to investigate the incidence of remote infection in each group. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
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| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Exclusion criteria are as follows. Receive thoracotomy or other organ resection. Laparoscopic (assisted) surgery. Cancer of the remnant stomach. Those who received steroid therapy or radiotherapy. Those who were allergic to beta lactumase inhibitor, pregnant, received antibiotic treatment in the past 2 weeks, had an infection at the time of surgery, had malignant disease of other organ. Those with cardiac dysfunction, liver dysfunction, renal dysfunction, severe diabetes mellitus, or ASA score >3. |
Related Information
| Primary Sponsor | Randomized clinical trial committee, Japan Society for Surgical Infection |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Society for Surgical Infection |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masato Kusunoki |
| Address | 2-174, Edobashi, Tsu, Mie, 514-8507, Japan Japan |
| Telephone | 059-231-5305 |
| Affiliation | Japan Society for Surgical Infection Chairman of randomized clinical trial committee |
| scientific contact | |
| Name | Yoshinobu Sumiyama |
| Address | 2-17-6, Ohashi, Meguro-Ku, Tokyo, 153-8515, Japan Japan |
| Telephone | 03-3481-7316 |
| Affiliation | Japan Society for Surgical Infection The Chief director |