UMIN-ICDS Clinical Trial

Public title

A Study on the Effect of Introducing PEG Gel Dural Sealant for Preventing Postoperative Cerebrospinal Fluid Leakage in Patients Who Underwent Dural Repair During Spinal Surgery

Acronym

PEG-DURA Study

Scientific Title

Effect of a Synthetic PEG Hydrogel Dural Sealant on Postoperative Cerebrospinal Fluid Leakage and Associated Symptoms in Spinal Surgery With Incidental or Intentional Durotomy: A Prospective Observational Study Using Interrupted Time Series Analysis

Scientific Title:Acronym

PEG-DURA Study

Region

Japan

Condition

Incidental or intentional durotomy requiring dural repair during spinal surgery

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine whether the introduction of a synthetic PEG dural sealant contributes to reducing postoperative CSF leakage and associated symptoms, thereby optimizing dural repair strategies and improving patient outcomes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Presence of postoperative cerebrospinal fluid (CSF) leakage within 30 days after surgery. CSF leakage will be defined as any of the following:
1. CSF-like drainage from the surgical wound, or drainage suspected to be CSF based on the characteristics of wound or drain output and diagnosed as CSF leakage by the treating physician.
2. Imaging findings (MRI, CT, etc.) demonstrating pseudomeningocele or other findings suggestive of CSF leakage that required therapeutic intervention (e.g., aspiration, drainage, or reoperation).
3. Reoperation performed due to CSF leakage.

Key secondary outcomes

The following outcomes will be evaluated (observation period: generally within 30 days after surgery, extended up to 90 days when necessary):
1. CSF leak-related headache: headache that worsens with postural change (supine to upright) and requires medical intervention such as additional analgesics or intravenous fluids, reduction in activity level, or delay in mobilization.
2. CSF leak-related nausea: nausea or vomiting requiring additional antiemetic treatment (intravenous or oral).
3. Additional interventions: lumbar drainage, aspiration/puncture, epidural blood patch, resuturing, or reoperation.
4. Repair-related indicators: operative time, time to first mobilization after surgery, length of hospital stay, readmission within 30 days, and surgical site infection.
5. Patient-reported outcome measures (PROMs): changes in headache and nausea numerical rating scale (NRS) scores and quality-of-life measures (e.g., EQ-5D-5L).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent spinal surgery (cervical, thoracic, or lumbar) and required intraoperative dural repair.
This includes cases in which an incidental durotomy occurred and required repair, as well as cases in which intentional durotomy (e.g., for intradural tumors) was performed and subsequently repaired.

Key exclusion criteria

Cases with preoperative cerebrospinal fluid (CSF) leakage (e.g., traumatic CSF leakage).
Cases judged to be inappropriate for inclusion by the principal investigator.
Patients who declined participation in the study (opt-out).

Target sample size

130

Name of lead principal investigator

1st name	Shota
Middle name
Last name	Takenaka

Organization

Japan Community Healthcare Organization Osaka Hospital

Division name

Department of orthopaedic surgery

Zip code

553-0003

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

TEL

06-6441-5451

Email

show@yb3.so-net.ne.jp

Name of contact person

1st name	Shota
Middle name
Last name	Takenaka

Organization

Japan Community Healthcare Organization Osaka Hospital

Division name

Department of orthopaedic surgery

Zip code

553-0003

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

TEL

06-6441-5451

Homepage URL

Email

show@yb3.so-net.ne.jp

Institute

Japan Community Healthcare Organization Osaka Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Japan Community Healthcare Organization Osaka Hospital review board

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

Tel

06-6441-5451

Email

horimoto-takiko@osaka.jcho.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

03

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

03

Month

03

Day

Date of IRB

2026

Year

03

Month

05

Day

Anticipated trial start date

2026

Year

03

Month

05

Day

Last follow-up date

2031

Year

02

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Single-center prospective observational study
Consecutive case registration
Cutoff point = Date of PEG sealant placement
Using segmented regression

Data to be Collected:
Data will be collected from medical records, operative reports, anesthesia records, nursing records, and imaging findings.
1. Patient characteristics: age, sex, BMI, smoking history, comorbidities (e.g., diabetes, renal dysfunction, steroid use), use of anticoagulant or antiplatelet drugs, and ASA physical status (ASA-PS).
2. Surgical information: diagnosis, surgical level (cervical/thoracic/lumbar), surgical approach or procedure (e.g., endoscopic, microscopic, decompression, with or without fusion), primary or revision surgery, operative time, and estimated blood loss.
3. Dural injury information: type of injury (incidental or planned), location and size of the defect (when available), repair method (e.g., suture, patch, fascia graft, fat graft, artificial dura), type and amount of sealant used, and use of lumbar drainage.
4. Postoperative management: presence of surgical drains and removal date, mobilization protocol, antibiotic administration, and postoperative imaging.
5. Clinical outcomes: postoperative cerebrospinal fluid (CSF) leakage, pseudomeningocele, wound-related complications, additional interventions (e.g., aspiration, epidural blood patch, reoperation), readmission within 30 days, and length of hospital stay.

Patient-Reported Outcome Measures (PROMs):
PROMs will be collected when feasible to assess symptoms related to CSF leakage and postoperative quality of life while minimizing patient burden.
1. Symptom scores: headache and nausea Numerical Rating Scale (NRS, 0-10).
2. Quality of life: EQ-5D-5L or other QOL scales routinely used at the institution.
3. Functional outcomes: spinal disease-specific measures routinely used at the institution (e.g., ODI, NDI, JOABPEQ), when available.

Registered date

2026

Year

03

Month

10

Day

Last modified on

2026

Year

03

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069650