Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery

NCT06607081 | Not Yet Recruiting DMC

• 1 other identifier: KY20242310wuzixiang
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the value of preoperative risk factor evaulation combined with perioperative ERAS measures in improving the clinical prognosis of elderly patients undergo the spinal fusion.

Conditions

Degenerative Spinal Disease; Elderly Patients; Spinal Fusion Acquired

Keywords

Elderly patients; ERAS; Spinal disease; Surgical intervention; Risk factors

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index

  The Comprehensive Complication Index (CCI) is based on the complication grading by the Clavien-Dindo Classification and captures every complication that occurred after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death) and reflects the gravity of this overall complication burden on the patients. CCI can be calculated using online CCI calculator (https://cci-calculator.com/cciCalculator), which is a tool to support the assessment of patients' overall morbidity after an intervention.

  24 weeks postoperation

Secondary Outcomes (9)

• Neck disability index (NDI) score/Oswestry disability index (ODI) score

  24 weeks postoperation

• North American Spine Satisfaction (NASS) Score

  24 weeks postoperation

• Japanese Orthopaedic Association (JOA) score

  24 weeks postoperation

• Bone minral density (BMD) evaluation

  24 weeks postoperation

• Spinal fusion rates

  24 weeks postoperation

Study Arms (2)

Perioperative Pre ERAS group

EXPERIMENTAL

Combination Product: Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention

Control group

NO INTERVENTION

Interventions

Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention COMBINATION_PRODUCT

The operative risk factors are multidisciplinary evaluated and the corresponded multimodal measures are used to optimize the whole condition of the elderly patient undergo spinal fusion surgery for his/her safty, early and fully recovery.

Perioperative Pre ERAS group

Eligibility Criteria

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

You may qualify if:

• Age ≥75 years old;
• Have degenerative spinal diseases, including cervical, thoracic and lumbar spine diseases;
• With severe neurological symptoms fail to conservative treatment and have to undergo the spinal fusion surgery;
• No serious cognitive impairment (MoCA score ≥8);
• No surgical contraindications;
• Anesthesia assessment patients can safely undergo surgery;
• Patients who voluntarily participate in and sign informed consent, can independently complete effective questionnaires, and are willing to follow up according to clinical requirements.

You may not qualify if:

• Patients who could not cooperate with doctors to complete preoperative evaluation and postoperative follow-up;
• Patients requiring spinal intervention due to spinal infection, fracture or metastatic disease;
• Patients with cerebrovascular accidents in the last 30 days;
• Patients with hepatic encephalopathy or acute active hepatitis;
• Patients with severe renal insufficiency with creatinine\>2.5mg/dL or undergoing hemodialysis;
• Patients with severe lung and cardiovascular diseases, coagulation disorders, and anesthesia contraindications;
• Patients with poorly controlled diabetes (HBAlc\>8.0%);
• Patients who are participating in clinical trials of other drugs or medical devices;
• Patients requiring emergency surgery;
• Patients who are considered by the investigator to be unable to participate in this clinical trial due to other circumstances.

Sponsors & Collaborators

• Xijing Hospital: lead
• Shenzhen Hospital of Southern Medical University: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (2)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (7)

• Chotai S, Devin CJ, Archer KR, Bydon M, McGirt MJ, Nian H, Harrell FE Jr, Dittus RS, Asher AL; QOD Vanguard Sites. Effect of patients' functional status on satisfaction with outcomes 12 months after elective spine surgery for lumbar degenerative disease. Spine J. 2017 Dec;17(12):1783-1793. doi: 10.1016/j.spinee.2017.05.027. Epub 2017 Sep 29.

  PMID: 28970074 BACKGROUND

• Kim TI, Brahmandam A, Skrip L, Sarac T, Dardik A, Ochoa Chaar CI. Surgery for the Very Old: Are Nonagenarians Different? Am Surg. 2020 Jan 1;86(1):56-64.

  PMID: 32077417 BACKGROUND

• Kim DU, Park HK, Lee GH, Chang JC, Park HR, Park SQ, Cho SJ. Central Sarcopenia, Frailty and Comorbidity as Predictor of Surgical Outcome in Elderly Patients with Degenerative Spine Disease. J Korean Neurosurg Soc. 2021 Nov;64(6):995-1003. doi: 10.3340/jkns.2021.0074. Epub 2021 Oct 7.

  PMID: 34614555 BACKGROUND

• Carlstrom LP, Helal A, Perry A, Lakomkin N, Graffeo CS, Clarke MJ. Too frail is to fail: Frailty portends poor outcomes in the elderly with type II odontoid fractures independent of management strategy. J Clin Neurosci. 2021 Nov;93:48-53. doi: 10.1016/j.jocn.2021.08.027. Epub 2021 Sep 11.

  PMID: 34656260 BACKGROUND

• Debono B, Corniola MV, Pietton R, Sabatier P, Hamel O, Tessitore E. Benefits of Enhanced Recovery After Surgery for fusion in degenerative spine surgery: impact on outcome, length of stay, and patient satisfaction. Neurosurg Focus. 2019 Apr 1;46(4):E6. doi: 10.3171/2019.1.FOCUS18669.

  PMID: 30933923 BACKGROUND

• van Rooijen S, Carli F, Dalton S, Thomas G, Bojesen R, Le Guen M, Barizien N, Awasthi R, Minnella E, Beijer S, Martinez-Palli G, van Lieshout R, Gogenur I, Feo C, Johansen C, Scheede-Bergdahl C, Roumen R, Schep G, Slooter G. Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation. BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

  PMID: 30670009 BACKGROUND

• Soffin EM, Beckman JD, Tseng A, Zhong H, Huang RC, Urban M, Guheen CR, Kim HJ, Cammisa FP, Nejim JA, Schwab FJ, Armendi IF, Memtsoudis SG. Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery. Anesthesiology. 2020 Aug;133(2):350-363. doi: 10.1097/ALN.0000000000003346.

  PMID: 32433277 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Tianwen Gao, MD

CONTACT

+86-29-84771794; xjyyllwyh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)