Standardized Perioperative Care Protocol for Lumbar Fusion Surgery

Hebei Medical University Third Hospital

Status: Completed

Conditions: Degenerative Lumbar Spondylolisthesis

Treatments: Other: Conventional care; Behavioral: Standardized Perioperative Care Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07104448

KE2017-011-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 382 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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382 participants in 2 patient groups

Experimental: Standardized Perioperative Care Protocol (SPCP) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Standardized Perioperative Care Protocol

Active Comparator: Conventional Care Group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional care