Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery

NCT07837427 | Recruiting

• 1 other identifier: 2026L053
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lumbar Disc Herniation; Lumbar Spinal Stenosis; Lumbar Degenerative Disease

Keywords

Unilateral Biportal Endoscopy; UBE; Irrigation Pressure; Fluid Bag Height; Incision Direction; Surgical Field Clarity; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Irrigation pressure around the dura

  Intraoperative irrigation pressure around the dura measured continuously during UBE surgery.

  During surgery

Study Arms (4)

0.9 m Fluid Bag Height + Transverse Incision

EXPERIMENTAL

UBE surgery with 0.9 m fluid bag height and transverse incision.

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.

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.

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.

Procedure: Unilateral Biportal Endoscopic Surgery

Interventions

Unilateral Biportal Endoscopic Surgery PROCEDURE

UBE surgery performed with specified fluid bag height (0.9 m or 1.0 m) and incision direction (transverse or longitudinal).

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fan Zhang: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement; Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fan Zhang, MD

CONTACT

+86 15087160418; zhangfan4@kmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Kunming Medical University

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 23, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)