UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057093 |
|---|---|
| Receipt number | R000065251 |
| Scientific Title | Standardization of Perioperative Antibiotic Therapy for High-Flow CSF Leak in Endoscopic Endonasal Surgery (PATH-EES) |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/07/03 16:26:18 |
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Basic information
Public title
Standardization of Perioperative Antibiotic Therapy for High-Flow CSF Leak in Endoscopic Endonasal Surgery (PATH-EES)
Acronym
PATH-EES
Scientific Title
Standardization of Perioperative Antibiotic Therapy for High-Flow CSF Leak in Endoscopic Endonasal Surgery (PATH-EES)
Scientific Title:Acronym
PATH-EES
Region
| Japan |
Condition
Condition
Patients who underwent endoscopic endonasal surgery for hypothalamic-pituitary disorders and skull base diseases
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study, designed as a multicenter retrospective study, aims to assess the current practices of perioperative antibiotic use in endoscopic endonasal surgery (EES) cases and identify the optimal antibiotic regimen for reducing the risk of surgical site infections (SSI). Specifically, it will examine the relationship between the type of antibiotics, duration of administration, timing of administration, and postoperative infection rates at each participating institution. Through this analysis, the study seeks to provide evidence that contributes to the standardization of perioperative antibiotic treatment in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Hasegawa |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Neurosurgery
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
+81-49-228-3671
hirotaka.hasegawa@ymail.ne.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kawaguchi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Neurosurgery
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
+81-49-228-3671
Homepage URL
tomidaifuzoku@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Saitama Medical Center, Saitama Medical University
Address
1981 Kamoda, Kawagoe, Saitama
Tel
+81-49-228-3411
smcrinri@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Period:
From the date of implementation approval by the head of the institution until March 31, 2030.
Study Population Period:
From October 1, 2022, to September 30, 2024.
Medical Records Reference Period:
From October 1, 2012, to December 31, 2024.
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065251
