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Ertapenem to prevent perineal incision infection after levator anus external abdomen perineum combined proctectomy (ELAPE): a single-arm, single-center clinical trial

Ertapenem to prevent perineal incision infection after levator anus external abdomen perineum combined proctectomy (ELAPE): a single-arm, single-center clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046176
Enrollment
Unknown
Registered
2021-05-08
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Postoperative wound infection

Interventions

Group A:Prophylactic intravenous drip of ertapenem 1.0g in a single-dose intravenous administration 1 hour before the skin incision and within 24 hours after the operation through the levator ani, ext

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with rectal cancer undergoing levator anus external abdominal perineum combined proctectomy (ELAPE); 3. General status ECOG (Eastern Cooperative Oncology Group) determines the clinical status as 0-1 grade; 4. Those who are expected to survive more than 6 months; 5. Liver and kidney functions are normal: such as plasma total bilirubin and creatinine =90g/L; 7. The subject voluntarily joined the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with immunodeficiency; 2. Those who are allergic to carbapenem drugs; 3. Those who are taking antibiotics for other reasons; 4. Creatinine clearance rate < 30ml/min and those with severe kidney disease or requiring dialysis; 5. Combined with other serious diseases: such as myocardial infarction and uncontrollable diabetes within 6 months, which are considered unsuitable to participate in the trial; 6. Pregnant women and patients with mental illness; 7. Participate in other drug clinical trials within 3 months; 8. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway.

Design outcomes

Primary

MeasureTime frame
Incidence of perineal incision infection;

Secondary

MeasureTime frame
Perineal incision pain score;Perineal incision infection readmission rate;Postoperative hospital stay;

Countries

China

Contacts

Public ContactHuang Ying

Fujian Medical University Union Hospital

hy9033sy@sina.com+86 13365910923

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026