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Randomized clinical trial about the period of antimicrobial prophylaxis administration in total gastrectomy for gastric cancer.

Randomized clinical trial about the period of antimicrobial prophylaxis administration in total gastrectomy for gastric cancer. - RCT of antimicrobial prophylaxis in total gastrectomy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001062
Enrollment
460
Registered
2008-03-03
Start date
2008-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer patients undergoing elective total gastrectomy

Interventions

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 administ

Sponsors

Randomized clinical trial committee, Japan Society for Surgical Infection
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Gastric cancer patients undergoing elective total gastrectomy (up to D2 lymph node resection by Japanese classification and R0 resection by UICC TNM Classification).

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
The secondary outcome is to investigate the incidence of remote infection in each group.

Countries

Japan

Contacts

Public ContactMasato Kusunoki

Japan Society for Surgical Infection Chairman of randomized clinical trial committee

059-231-5305

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026