A prospective study of the relationship between drain position and postoperative hematoma and decompression status after full-endoscopic lumbar decompression

Association between postoperative drain tip position and postoperative epidural hematoma and decompression findings after full-endoscopic unilateral laminotomy for bilateral decompression: a prospective observational study - FESS-Drain Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061647

Enrollment

100

Registered

2026-05-21

Start date

2026-05-21

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

lumbar spinal canal stenosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be included. 1. Patients undergoing full-endoscopic unilateral laminotomy for bilateral decompression for lumbar spinal canal stenosis, mainly degenerative disease, at our institution. 2. Age at surgery 20 years or older. 3. Patients undergoing CT at 1-2 days postoperatively, MRI at 3-4 days postoperatively, and MRI at 6 months postoperatively according to the clinical pathway at our institution.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded. 1. Patients whose main pathology is other than lumbar spinal canal stenosis, such as tumor, infection, trauma, or inflammatory disease. 2. Patients undergoing concomitant fusion or instrumentation. 3. Patients who cannot undergo postoperative MRI because of contraindications or other reasons. 4. Patients who refuse participation in the study through the opt-out process. 5. Patients judged by the principal investigator to be unsuitable for the study, such as cases in which imaging evaluation is technically difficult.

Design outcomes

Primary

Measure	Time frame
Association between the drain tip position grade assessed by CT 1-2 days postoperatively and the epidural hematoma/fluid collection occupancy rate (%) and hematoma severity grade (0-3) assessed by MRI 3-4 days postoperatively.	—

Secondary

Measure	Time frame
1. Drainage volume (total and by time interval). 2. Dural sac cross-sectional area (DSCSA) at postoperative day 3 and 6 months, and changes in DSCSA. 3. Clinical events up to 30 days postoperatively, including symptomatic hematoma, reoperation, and readmission. 4. Associations between imaging findings and patient-reported outcome measures at 3, 6, and 12 months postoperatively, including VAS, ODI, and JOA scores.	—

Measure

Time frame

1. Drainage volume (total and by time interval). 2. Dural sac cross-sectional area (DSCSA) at postoperative day 3 and 6 months, and changes in DSCSA. 3. Clinical events up to 30 days postoperatively, including symptomatic hematoma, reoperation, and readmission. 4. Associations between imaging findings and patient-reported outcome measures at 3, 6, and 12 months postoperatively, including VAS, ODI, and JOA scores.

—

Countries

Japan

Contacts

Public ContactShota Takenaka

Japan Community Healthcare Organization Osaka Hospital Department of orthopaedic surgery

show@yb3.so-net.ne.jp0664415451

Outcome results