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Standardization of Perioperative Antibiotic Therapy for High-Flow CSF Leak in Endoscopic Endonasal Surgery (PATH-EES)

Standardization of Perioperative Antibiotic Therapy for High-Flow CSF Leak in Endoscopic Endonasal Surgery (PATH-EES) - PATH-EES

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057093
Enrollment
1800
Registered
2025-03-31
Start date
2025-04-03
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 who underwent endoscopic endonasal surgery for hypothalamic-pituitary disorders and skull base diseases

Interventions

None listed

Sponsors

Saitama Medical Center, Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals who meet all of the following criteria: Underwent EES for a skull base lesion during the study period (October 1, 2022, to September 30, 2024; two years). Adults (18 years or older). Have follow-up data for at least 30 days from the date of surgery.

Exclusion criteria

Exclusion criteria: Individuals who meet any of the following criteria will be excluded: Underwent surgery primarily for the closure of a CSF leak. Underwent transnasal surgery for the treatment of an infection (e.g., abscess, fungal infection). Minors (under 18 years old). Underwent combined transnasal and craniotomy procedures. Severe liver dysfunction (Child-Pugh classification B or C). Patients with preoperative conditions or medication history that may result in immunosuppression, including: HIV infection Use of immunosuppressive drugs: Corticosteroids (e.g., prednisolone)* Calcineurin inhibitors (e.g., cyclosporine, tacrolimus) Antimetabolites (e.g., mycophenolate mofetil, mizoribine, azathioprine) mTOR inhibitors (e.g., everolimus) Infliximab or similar agents Pregnant individuals *The use of corticosteroids for replacement therapy in cases of anterior pituitary insufficiency or for perioperative management concerns will not be considered an exclusion criterion.

Design outcomes

Primary

MeasureTime frame
The presence or absence of SSI within 30 days from the date of surgery will be evaluated as an outcome measure. However, information on infections that occur beyond 31 days and resemble SSI will also be collected and presented as a reference item.

Countries

Japan

Contacts

Public ContactYuki Kawaguchi

Saitama Medical Center, Saitama Medical University Department of Neurosurgery

tomidaifuzoku@yahoo.co.jp+81-49-228-3671

Outcome results

None listed

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