The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study

The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study - The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042658

Enrollment

Registered

2021-01-04

Start date

2021-01-04

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

Rectal cancer, Anal canal cancer

Interventions

Sulbactam/Ampicillin (SBT/AMPC) Cefmetazole (CMZ)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients for whom abdominoperineal resection (APR) is the planned procedure for rectal cancer and anal canal cancer Patients with an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-2 Patients who are between 20 and 85 years of age at the time of obtaining consent Patients who have been fully informed and understandably given their voluntary written consent to participate in this study major organ functions are preserved on clinical examination within 30 days of enrollment

Exclusion criteria

Exclusion criteria: Patients who meet any of the following conditions are not eligible (1) Patients with previous hypersensitivity to SBT/ABPC or CMZ (2) Emergency surgery (3) Patients with poorly controlled diabetes (HbA1c over 8.0), chronic renal failure requiring dialysis, and patients requiring immunosuppressive drugs (4) Patients with a systemic active infection or fever (>38 degrees Celsius) and suspected infection (5) Patients who are either pregnant, likely to be pregnant, within 28 days after delivery, or breastfeeding (6) Serious organ failure (7) As a result of preoperative explanations, cases of disagreement (8) Any other patient whom the principal investigator or the researcher determines to be unsuitable for the safe conduct of the study

Design outcomes

Primary

Measure	Time frame
Incidence of perineal wound infection within 30 days after surgery	—

Secondary

Measure	Time frame
1 Incidence of all SSI(surgical site infection) 2 Percentage of all complications, excluding SSI, within 30 days of surgery. 3 Methicillin-resistant Staphylococcus Aureus (MRSA) detection rate 4 Post-operative hospital stay	—

Countries

Japan

Contacts

Public ContactAkitoshi Nankaku

Tokyo Medical and Dental University Gastrointestinal Surgery

nanksrg1@tmd.ac.jp03-5803-6111

Outcome results

None listed

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