Standardized Perioperative Care Protocol for Lumbar Fusion Surgery

NCT ID: NCT07104448

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2025-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Standardized Perioperative Care Protocol (SPCP) Group

Patients randomized to this group received a multi-modal, standardized protocol that included: comprehensive preoperative education and optimization; standardized intraoperative anesthesia and surgical techniques; and a structured postoperative rehabilitation program featuring multimodal analgesia and goal-directed early mobilization.

Group Type: EXPERIMENTAL

Standardized Perioperative Care Protocol

Intervention Type: BEHAVIORAL

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.

Active Comparator: Conventional Care Group

Patients randomized to this group received standard institutional care, which was not protocolized. This typically involved surgeon-preference-based perioperative management, variable timing for mobilization and catheter removal, and discharge based on the attending surgeon's general assessment.

Group Type: ACTIVE_COMPARATOR

Conventional care

Intervention Type: OTHER

Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.

Interventions

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.

Intervention Type: BEHAVIORAL

Conventional care

Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Symptomatic, single-level (L3-L4, L4-L5, or L5-S1) degenerative spondylolisthesis (Meyerding Grade I or II).
• Failure of at least 6 months of conservative therapy.
• Age between 40 and 75 years.
• Suitable for and scheduled to undergo transforaminal lumbar interbody fusion (TLIF) surgery.
• Provided written informed consent.

Exclusion Criteria

• High-grade spondylolisthesis (Grade > II).
• History of previous lumbar surgery.
• Presence of active spinal infection, tumor, or trauma.
• Severe osteoporosis (T-score < -3.0).
• Significant medical comorbidities precluding major surgery (ASA physical status > III).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Baoli Li

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

KE2017-011-1

Identifier Type: -

Identifier Source: org_study_id