Lumbar Disc HerniationNCT07837427
Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery
A study testing Unilateral Biportal Endoscopic Surgery in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Fan Zhang at 1 site in China.
Trial summary
This study is being done to find out if the height of the fluid bag and the direction of the surgical cut affect the pressure of the fluid used during unilateral biportal endoscopic (UBE) spine surgery. UBE is a minimally invasive surgery for the spine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Degenerative Disease
- What is being tested?
- Unilateral Biportal Endoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years and < 75 years.
- Patients scheduled for unilateral biportal endoscopic (UBE) surgery for lumbar degenerative disease at the First Affiliated Hospital of Kunming Medical University between February 2026 and December 2027.
- Follow-up duration > 6 months.
- Complete clinical and follow-up data available.
- Voluntary participation and signed informed consent.
Who cannot join
- History of tuberculosis, infection, tumor, or trauma.
- Severe cardiac, hepatic, or renal insufficiency.
- History of chronic lung disease, liver disease, HIV infection, diabetes, or renal insufficiency.
- Psychiatric disorders or inability to comply with follow-up.
- Severe osteoporosis.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Fan Zhang, MD, +86 15087160418, zhangfan4@kmmu.edu.cn
About this study
This study is being done to find out if the height of the fluid bag and the direction of the surgical cut affect the pressure of the fluid used during unilateral biportal endoscopic (UBE) spine surgery. UBE is a minimally invasive surgery for the spine. During this surgery, fluid is used to keep the surgical area clear and to control bleeding. The pressure of this fluid may affect how clear the surgical view is, how much bleeding occurs, and how well patients recover after surgery. We will also collect disc tissue removed during surgery to study how disc degeneration is related to factors such as sex, age, mechanical stress, and injury. About 80 patients aged 18 to 75 who are scheduled for UBE surgery at our hospital will take part. Patients will be randomly assigned to one of four groups based on two things: the height of the fluid bag (0.9 meters or 1.0 meters) and the direction of the surgical cut (horizontal or vertical). We will measure the fluid pressure around the spinal covering during surgery and record how clear the surgical view is. After surgery, we will track patients' pain and recovery for at least 6 months. This study has been approved by the hospital ethics committee.
Read the detailed description
Background: Unilateral biportal endoscopy (UBE) is a minimally invasive spine surgery technique that has been increasingly used for lumbar disc herniation, spinal stenosis, and other degenerative conditions. Irrigation fluid is essential in UBE to maintain the surgical space and control bleeding. However, the pressure of irrigation fluid may be associated with complications such as neck pain, seizures, and increased intracranial pressure. The height of the fluid bag and the direction of the surgical incision are two controllable factors that may influence actual irrigation pressure and surgical field clarity, but prospective clinical evidence is lacking.
Objective: This study aims to investigate the effects of different fluid bag heights (0.9 m vs. 1.0 m) and incision directions (horizontal vs. vertical) on irrigation pressure, surgical field clarity, blood loss, and early postoperative pain and functional recovery in patients undergoing UBE surgery. Additionally, disc tissue collected during surgery will be used to explore the relationship between disc degeneration and factors such as sex, age, mechanical stress, and injury.
Design: This is a single-center, prospective, randomized controlled trial. Approximately 80 patients scheduled for UBE surgery at the First Affiliated Hospital of Kunming Medical University will be enrolled. Patients will be randomly assigned to one of four groups: (1) 0.9 m fluid bag height + horizontal incision; (2) 0.9 m fluid bag height + vertical incision; (3) 1.0 m fluid bag height + horizontal incision; (4) 1.0 m fluid bag height + vertical incision. Intraoperative irrigation pressure around the dura will be continuously measured. Surgical field clarity, blood loss, and early postoperative outcomes will be recorded. Patients will be followed for at least 6 months.
- Being tested
- Unilateral Biportal Endoscopic Surgery
- Keywords
- Unilateral Biportal Endoscopy, UBE, Irrigation Pressure, Fluid Bag Height, Incision Direction, Surgical Field Clarity, Postoperative Recovery
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Biportal Endoscopic SurgeryProcedure or surgery
UBE surgery performed with specified fluid bag height (0.9 m or 1.0 m) and incision direction (transverse or longitudinal).
| Study group | Role | What they receive |
|---|---|---|
| 0.9 m Fluid Bag Height + Transverse Incision | Experimental | UBE surgery with 0.9 m fluid bag height and transverse incision. Receives: Procedure: Unilateral Biportal Endoscopic Surgery |
| 0.9 m Fluid Bag Height + Longitudinal Incision | Experimental | UBE surgery with 0.9 m fluid bag height and longitudinal incision. Receives: Procedure: Unilateral Biportal Endoscopic Surgery |
| 1.0 m Fluid Bag Height + Transverse Incision | Experimental | UBE surgery with 1.0 m fluid bag height and transverse incision. Receives: Procedure: Unilateral Biportal Endoscopic Surgery |
| 1.0 m Fluid Bag Height + Longitudinal Incision | Experimental | UBE surgery with 1.0 m fluid bag height and longitudinal incision. Receives: Procedure: Unilateral Biportal Endoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irrigation pressure around the dura
Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start5 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into four parallel groups based on two factors: fluid bag height (0.9 m or 1.0 m) and incision direction (horizontal or vertical). Randomization will be performed using computer-generated random numbers and sealed opaque envelopes.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fan Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Fan Zhang, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837427
- Sponsor's protocol ID
- 2026L053
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves a small sample of patients from a single center, and the data contain sensitive personal and surgical information. Protecting participant privacy and complying with local ethics regulations are the primary reasons for not sharing the data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery
- ClinicalTrials.gov ID
- NCT07837427
- Acronym / sponsor ID
- 2026L053
- Keywords
- Unilateral Biportal Endoscopy, UBE, Irrigation Pressure, Fluid Bag Height, Incision Direction, Surgical Field Clarity, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fan ZhangUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Sep 2026 (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.
This study is being done to find out if the height of the fluid bag and the direction of the surgical cut affect the pressure of the fluid used during unilateral biportal endoscopic (UBE) spine surgery. UBE is a minimally invasive surgery for the spine. During this surgery, fluid is used to keep the surgical area clear and to control bleeding. The pressure of this fluid may affect how clear the surgical view is, how much bleeding occurs, and how well patients recover after surgery. We will also collect disc tissue removed during surgery to study how disc degeneration is related to factors such as sex, age, mechanical stress, and injury. About 80 patients aged 18 to 75 who are scheduled for UBE surgery at our hospital will take part. Patients will be randomly assigned to one of four groups based on two things: the height of the fluid bag (0.9 meters or 1.0 meters) and the direction of the surgical cut (horizontal or vertical). We will measure the fluid pressure around the spinal covering during surgery and record how clear the surgical view is. After surgery, we will track patients' pain and recovery for at least 6 months. This study has been approved by the hospital ethics committee.
Detailed description
Background: Unilateral biportal endoscopy (UBE) is a minimally invasive spine surgery technique that has been increasingly used for lumbar disc herniation, spinal stenosis, and other degenerative conditions. Irrigation fluid is essential in UBE to maintain the surgical space and control bleeding. However, the pressure of irrigation fluid may be associated with complications such as neck pain, seizures, and increased intracranial pressure. The height of the fluid bag and the direction of the surgical incision are two controllable factors that may influence actual irrigation pressure and surgical field clarity, but prospective clinical evidence is lacking.
Objective: This study aims to investigate the effects of different fluid bag heights (0.9 m vs. 1.0 m) and incision directions (horizontal vs. vertical) on irrigation pressure, surgical field clarity, blood loss, and early postoperative pain and functional recovery in patients undergoing UBE surgery. Additionally, disc tissue collected during surgery will be used to explore the relationship between disc degeneration and factors such as sex, age, mechanical stress, and injury.
Design: This is a single-center, prospective, randomized controlled trial. Approximately 80 patients scheduled for UBE surgery at the First Affiliated Hospital of Kunming Medical University will be enrolled. Patients will be randomly assigned to one of four groups: (1) 0.9 m fluid bag height + horizontal incision; (2) 0.9 m fluid bag height + vertical incision; (3) 1.0 m fluid bag height + horizontal incision; (4) 1.0 m fluid bag height + vertical incision. Intraoperative irrigation pressure around the dura will be continuously measured. Surgical field clarity, blood loss, and early postoperative outcomes will be recorded. Patients will be followed for at least 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomized into four parallel groups based on two factors: fluid bag height (0.9 m or 1.0 m) and incision direction (horizontal or vertical). Randomization will be performed using computer-generated random numbers and sealed opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| 0.9 m Fluid Bag Height + Transverse Incision | Experimental | Procedure: Unilateral Biportal Endoscopic SurgeryUBE surgery with 0.9 m fluid bag height and transverse incision. |
| 0.9 m Fluid Bag Height + Longitudinal Incision | Experimental | Procedure: Unilateral Biportal Endoscopic SurgeryUBE surgery with 0.9 m fluid bag height and longitudinal incision. |
| 1.0 m Fluid Bag Height + Transverse Incision | Experimental | Procedure: Unilateral Biportal Endoscopic SurgeryUBE surgery with 1.0 m fluid bag height and transverse incision. |
| 1.0 m Fluid Bag Height + Longitudinal Incision | Experimental | Procedure: Unilateral Biportal Endoscopic SurgeryUBE surgery with 1.0 m fluid bag height and longitudinal incision. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >= 18 years and < 75 years.
- Patients scheduled for unilateral biportal endoscopic (UBE) surgery for lumbar degenerative disease at the First Affiliated Hospital of Kunming Medical University between February 2026 and December 2027.
- Follow-up duration > 6 months.
- Complete clinical and follow-up data available.
- Voluntary participation and signed informed consent.
Key exclusion criteria (6 listed)
- History of tuberculosis, infection, tumor, or trauma.
- Severe cardiac, hepatic, or renal insufficiency.
- History of chronic lung disease, liver disease, HIV infection, diabetes, or renal insufficiency.
- Psychiatric disorders or inability to comply with follow-up.
- Severe osteoporosis.
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 |
|---|---|---|
| Unilateral Biportal Endoscopic SurgeryUBE surgery performed with specified fluid bag height (0.9 m or 1.0 m) and incision direction (transverse or longitudinal). | Procedure or surgery | 0.9 m Fluid Bag Height + Longitudinal Incision, 0.9 m Fluid Bag Height + Transverse Incision, 1.0 m Fluid Bag Height + Longitudinal Incision, 1.0 m Fluid Bag Height + Transverse Incision |
Primary outcome
Irrigation pressure around the dura
Time frame: During surgery
Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a small sample of patients from a single center, and the data contain sensitive personal and surgical information. Protecting participant privacy and complying with local ethics regulations are the primary reasons for not sharing the data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Biportal Endoscopic Surgery in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Fan Zhang 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fan Zhang, MD (+86 15087160418, zhangfan4@kmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irrigation pressure around the dura (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.