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Standardized Perioperative Care Protocol for Lumbar Fusion Surgery

NCT07104448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2025-08-05

No results posted yet for this study

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.

Conditions

  • Degenerative Lumbar Spondylolisthesis

Interventions

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.

Sponsors & Collaborators

  • Hebei Medical University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-06-01
Completion
2025-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07104448 on ClinicalTrials.gov