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Randomized clinical trial about the period of antimicrobial prophylaxis administration in rectal cancer surgery

Randomized clinical trial about the period of antimicrobial prophylaxis administration in rectal cancer surgery - RCT of antimicrobial prophylaxis in rectal cancer surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000993
Enrollment
460
Registered
2008-01-25
Start date
2008-01-01
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

Patients undergoing elective rectal cancer surgery

Interventions

Cefmetazole is administered afetr the induction of anesthesia, and the patients recieved an additional dose if the operation was prolonged beyond 3 hour, and cefmetazole was administered agin twice da

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing elective rectal cancer surgery which is R0 resection (UICC TNM Classification).

Exclusion criteria

Exclusion criteria: The exclusion criteria were a bowel obstruction or stenosis, reconstruction of stoma before rectal resection, laparoscopic surgery, combined resection with other organ, known allergy to a beta-lactam, treatment with any antibiotic within the past 2 weeks, pregnancy, and evidence of an infection at the time of surgery, ASA score more than 3, and recived preoperative chemoterapy and/or radiotherapy. Patients are also excluded if they had liver or cardiac, renal dysfunction, and if their physician decided unfit for this study.

Design outcomes

Primary

MeasureTime frame
The primary outcome is to show that a 24 hours antibiotic administarion 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