Drain Tube Influence the Postoperative Epidural HaematomaNCT06290791
Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery?
A study testing two level lumbar decompression with BESS procedure received one drain. and two level lumbar decompression with BESS procedure received two drain. in people with Drain Tube Influence the Postoperative Epidural Haematoma, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Drain Tube Influence the Postoperative Epidural Haematoma
- What is being tested?
- two level lumbar decompression with BESS procedure received one drain. and two level lumbar decompression with BESS procedure received two drain.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2020to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with two level lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy were eligible for inclusion.
Who cannot join
- Patients were excluded if radiography revealed lumbar instability (motion of >3mm at the level of listhesis), if they had had previous lumbar spinal surgery, or they had American Society of Anesthesiologists (ASA) class Ⅳ or severe systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? A Randomized, Controlled Trial
The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis.
Read the detailed description
How to reduce the rate of POSEH after lumbar spinal surgery is an obvious concern for spine surgeon. Wound drains were recognized as effective methods and typically used to prevent the development of symptomatic epidural hematomas after spinal surgery. However, whether range prophylactic postoperative drainage after spinal decompression for the prevention of POSEH is still controversial. Although there have been many studies focusing on the potential associations between wound drains and POSEH after lumbar spinal surgery, a prospective study focusing on the role of drains in minimally invasive surgery of BESS for lumbar spinal decompression has been rare. In present study, our team sought to investigate the influence of wound drains for POSEH and provide clinical evidence for the selection of drainage in BESS procedures for the decompression of lumbar spinal stenosis.
- Being tested
- two level lumbar decompression with BESS procedure received one drain., two level lumbar decompression with BESS procedure received two drain.
- Keywords
- Spinal epidural hematoma, Decompression surgery, Lumbar spinal stenosis
- Medical subject headings
- Hematoma, Epidural, Spinal, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two level lumbar decompression with BESS procedure received one drain.Procedure or surgery
patients who underwent two level lumbar decompression with BESS procedure received one drain.
two level lumbar decompression with BESS procedure received two drain.Procedure or surgery
patients who underwent two level lumbar decompression with BESS procedure received two drains
| Study group | Role | What they receive |
|---|---|---|
| group A (with one drain) | Experimental | Not described Receives: Procedure: two level lumbar decompression with BESS procedure received one drain. |
| the group B (with two drains) | Active comparator | Not described Receives: Procedure: two level lumbar decompression with BESS procedure received two drain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cross-sectional area of POSEH
the cross-sectional area of the 72th-hour POSEH after surgery
Measured: 24 hours after drain withdrawal
Secondary outcomes (1)
the volume of drain output
the total volume of the drain or drains
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start31 Dec 2020
- Primary completion31 Dec 2023
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drain Tube Influence the Postoperative Epidural HaematomaStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290791
- Sponsor's protocol ID
- K2020214
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhong Z, Ying J, Zhang S, Cai K, Jing X, Xu Z, Jiang L, Wu T, Wei G, Hu Q. Does the number of drain tubes influence the formation of postoperative spinal epidural hematoma following biportal endoscopic unilateral laminotomy for bilateral decompression (BE-ULBD) in patients with two-level adjacent lumbar spinal stenosis? a prospective randomized study. J Orthop Surg Res. 2025 Jun 24;20(1):615. doi: 10.1186/s13018-025-06042-1.
PubMed 40551242
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Drain Tube Influence the Postoperative Epidural Haematoma for Lumbar Biportal Endoscopic Surgery? A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06290791
- Acronym / sponsor ID
- K2020214
- Keywords
- Spinal epidural hematoma, Decompression surgery, Lumbar spinal stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate if wound drains could influence postoperative spinal epidural hematoma (POSEH) in biportal endoscopic spinal surgery (BESS) procedures for decompression of lumbar spinal stenosis.
Detailed description
How to reduce the rate of POSEH after lumbar spinal surgery is an obvious concern for spine surgeon. Wound drains were recognized as effective methods and typically used to prevent the development of symptomatic epidural hematomas after spinal surgery. However, whether range prophylactic postoperative drainage after spinal decompression for the prevention of POSEH is still controversial. Although there have been many studies focusing on the potential associations between wound drains and POSEH after lumbar spinal surgery, a prospective study focusing on the role of drains in minimally invasive surgery of BESS for lumbar spinal decompression has been rare. In present study, our team sought to investigate the influence of wound drains for POSEH and provide clinical evidence for the selection of drainage in BESS procedures for the decompression of lumbar spinal stenosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A (with one drain) | Experimental | Procedure: two level lumbar decompression with BESS procedure received one drain. |
| the group B (with two drains) | Active comparator | Procedure: two level lumbar decompression with BESS procedure received two drain. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with two level lumbar stenosis and neurogenic claudication with or without lumbar radiculopathy were eligible for inclusion.
Key exclusion criteria (1 listed)
- Patients were excluded if radiography revealed lumbar instability (motion of >3mm at the level of listhesis), if they had had previous lumbar spinal surgery, or they had American Society of Anesthesiologists (ASA) class Ⅳ or severe systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two level lumbar decompression with BESS procedure received one drain.patients who underwent two level lumbar decompression with BESS procedure received one drain. | Procedure or surgery | group A (with one drain) |
| two level lumbar decompression with BESS procedure received two drain.patients who underwent two level lumbar decompression with BESS procedure received two drains | Procedure or surgery | the group B (with two drains) |
Primary outcome
the cross-sectional area of POSEH
Time frame: 24 hours after drain withdrawal
the cross-sectional area of the 72th-hour POSEH after surgery
1 secondary outcome
the volume of drain output
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Derived from this study: PubMed 40551242Zhong Z, Ying J, Zhang S, Cai K, Jing X, Xu Z, Jiang L, Wu T, Wei G, Hu Q. Does the number of drain tubes influence the formation of postoperative spinal epidural hematoma following biportal endoscopic unilateral laminotomy for bilateral decompression (BE-ULBD) in patients with two-level adjacent lumbar spinal stenosis? a prospective randomized study. J Orthop Surg Res. 2025 Jun 24;20(1):615. doi: 10.1186/s13018-025-06042-1.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two level lumbar decompression with BESS procedure received one drain. and two level lumbar decompression with BESS procedure received two drain. in people with Drain Tube Influence the Postoperative Epidural Haematoma, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the cross-sectional area of POSEH (time frame: 24 hours after drain withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.