NCT07104448

Standardized Perioperative Care Protocol for Lumbar Fusion Surgery

Impact of a Standardized Perioperative Care Protocol on Functional and Radiographic Outcomes Following Transforaminal Lumbar Interbody Fusion for Degenerative Spondylolisthesis: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Hebei Medical University Third Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized controlled trial to evaluate whether a comprehensive, standardized perioperative care protocol (SPCP) improves functional recovery, radiographic outcomes, and quality of life compared to conventional care in patients undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar spondylolisthesis. The study aims to demonstrate that a protocol-driven approach can lead to better patient outcomes and increased healthcare efficiency.

Detailed description

Transforaminal lumbar interbody fusion (TLIF) is a common surgical treatment for degenerative lumbar spondylolisthesis, but patient outcomes can be variable due to inconsistencies in perioperative management. Enhanced Recovery After Surgery (ERAS) principles have shown promise, but their comprehensive application in spine surgery requires further validation. This study hypothesizes that a multifaceted Standardized Perioperative Care Protocol (SPCP), which integrates preoperative optimization (education, nutrition), standardized intraoperative techniques, and a structured, goal-directed postoperative rehabilitation plan, will result in superior outcomes compared to conventional, non-protocolized care. A total of 382 patients were randomized to either the SPCP or conventional care group. The study will assess outcomes at multiple time points up to 2 years post-surgery to determine the long-term efficacy of the protocol in improving functional recovery, spinal fusion, quality of life, and reducing complications.

Conditions

• Degenerative Lumbar Spondylolisthesis

Interventions

Type	Name	Description
BEHAVIORAL	Standardized Perioperative Care Protocol	A multi-component protocol involving preoperative patient education, nutritional screening, standardized anesthesia, goal-directed fluid therapy, multimodal opioid-sparing analgesia, and a structured physiotherapy-led mobilization schedule starting on postoperative day 1.
OTHER	Conventional care	Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-06-01
• Completion: 2025-05-01
• First posted: 2025-08-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: China