A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery

A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery - A randomized controlled trial of reducing effect of postoperative epidural haematoma formation by the use of gelatin hemostatic matrix with human thrombin (FloSeal) in cases with lumbar spinal canal stenosis treated by microendscopic surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026255

Enrollment

Registered

2017-02-22

Start date

2017-02-22

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

When decompression procedure is finished and operation of hemostasis is completed in microendoscopic spinal surgery, surgeon is told whether the patient belongs to a group of FloSeal or control. If a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with lumbar spinal canal stenosis who undergo microendoscopic spinal surgery in our hospital

Exclusion criteria

Exclusion criteria: Patients who have hemorrahagic factors (hemodialysis, liver cirrhosis, etc) Patients of foraminal stenosis Patients of re-operation Patients who suffer dural tear intraoperatively Patients whose drainage is put unsuitably Patients who are thought that use of FloSeal is mandatory because of difficulty of hemostasis in the surgical field Others who are inadequate to current study

Design outcomes

Primary

Measure	Time frame
quantity of postoperative drainage at 36 hours after surgery	—

Secondary

Measure	Time frame
numerical rating scale(NRS) of postoperative leg pain size of area of haematoma on the axial image of MRI examined a few days after surgery	—

Countries

Japan

Contacts

Public ContactMasanari Takami

Wakayama Medical University Department of orthopaedic surgery

maatomo324@gmail.com073-441-0645

Outcome results

None listed

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