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

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 - PEG-DURA Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060882

Enrollment

130

Registered

2026-03-21

Start date

2026-03-05

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

Incidental or intentional durotomy requiring dural repair during spinal surgery

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Japan

Contacts

Public ContactShota Takenaka

Japan Community Healthcare Organization Osaka Hospital Department of orthopaedic surgery

show@yb3.so-net.ne.jp06-6441-5451

Outcome results