UMIN-ICDS Clinical Trial

Public title

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

Acronym

FESS-Drain Study

Scientific Title

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

Scientific Title:Acronym

FESS-Drain Study

Region

Japan

Condition

lumbar spinal canal stenosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify whether drain tip position assessed by CT 1-2 days after full-endoscopic unilateral laminotomy for bilateral decompression is associated with the amount and severity of postoperative epidural hematoma/fluid collection and decompression parameters assessed by MRI 3-4 days postoperatively, thereby informing optimization of postoperative management.

Basic objectives2

Others

Basic objectives -Others

Postoperative imaging evaluation

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

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.

Key secondary outcomes

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.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

100

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

0664415451

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

0664415451

Homepage URL

Email

show@yb3.so-net.ne.jp

Institute

Japan Community Healthcare Organization Osaka Hospital

Institute

Department

Personal name

Organization

self funnding

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

05

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

Open public recruiting

Date of protocol fixation

2026

Year

05

Month

10

Day

Date of IRB

2026

Year

05

Month

21

Day

Anticipated trial start date

2026

Year

05

Month

21

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design: Single-center prospective observational study.
Recruitment: Consecutive patients undergoing full-endoscopic unilateral laminotomy for bilateral decompression (FESS-ULBD) for lumbar spinal stenosis.
Units: Registration: patient. Analysis: patient, surgery, or decompressed level as prespecified.
Sampling: Consecutive.
Main predictor: Drain tip position grade on CT at POD1-2.
Main outcomes: Epidural hematoma/fluid collection occupancy rate (%) and hematoma grade (0-3) on MRI at POD3-4.
Drain management: A 3.5-mm SB bag (Sumitomo Bakelite) with suction adjusted so the balloon contacts the wall.
Data collection:
- Patient factors: age, sex, BMI, comorbidities, anticoagulant/antiplatelet use.
- Surgical data: diagnosis, surgery date, procedure, level, decompression extent, operative time, blood loss.
- Drain data: tip position, drainage volume (total and interval), timing of removal.
- Imaging: preoperative MRI; CT POD1-2; MRI POD3-4 and 6 months; radiographs as needed. CT will assess drain tip position; MRI will assess hematoma/fluid collection and decompression status.
- Clinical course: events within 30 days, including symptomatic hematoma, reoperation, readmission.
- PROMs: VAS, ODI, JOA, and routine-care measures at 3, 6, and 12 months.
Statistical analysis: Descriptive statistics for baseline, surgical, drain, and imaging variables. Primary analysis will evaluate associations between drain tip position grade and hematoma occupancy rate or hematoma grade on POD3-4 MRI using mixed-effects models, ordinal logistic regression, or other appropriate models accounting for within-patient correlation. Secondary analyses will examine associations with drainage volume, DSCSA, and PROMs.

Registered date

2026

Year

05

Month

21

Day

Last modified on

2026

Year

05

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070391