Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery

NCT06140797 | Completed

• 1 other identifier: lushibao
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 3

Brief Summary

With the extended life expectancy of the Chinese population and improvements in surgery and anesthesia techniques, the number of aged patients undergoing surgery has been increasing annually. However, safety, effectiveness, and quality of life of aged patients undergoing surgery are facing major challenges. This prospective, multi-center, randomized, controlled study aims to construct a prehabilitation combined with enhanced recovery after surgery program which includes pre-operative risk assessment and targeted intervention.

Conditions

Spine Degeneration; Spine Fusion; Frailty Syndrome

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. Postoperative complications were recorded to 90-day after surgery (definitions provided in supplementary table 1) and scored by severity using the Clavien-Dindo classification. The CCI was derived from these scores using the CCI calculator available online (http://www.assessurgery.com). Previous studies have validated the CCI as a measure of postoperative morbidity, suggesting that it offers a more comprehensive and sensitive endpoint for surgical research compared to traditional morbidity measures, such as the overall rate of complications or the rate of severe complications.

  up to 90 days after surgery

Secondary Outcomes (8)

• Neck/Oswestry disability index

  up to 90 days after surgery

• EuroQol Five Dimensions Questionnaire (EQ-5D)

  up to 90 days after surgery

• 6 m walking speed

  up to 90 days after surgery

• North American Spine Society scores

  up to 90 days after surgery

• Primary and total length of hospital stay

  up to 90 days after surgery

Study Arms (2)

PREERAS group

EXPERIMENTAL

Pre-operative risk assessment combined with targeted intervention During the planning phase of the study, we assembled a multidisciplinary team consisting of geriatrician, spine surgeons, nurses, rehabilitation specialists, anesthesiologists, neurologists, nutritionist, and social workers. Then, the multimodal prehabilitation combined with perioperative ERAS care (PREERAS) programme was conducted based on previous studies and surgical guideline. Participants randomised to the intervention group will receive PREERAS management. PREERAS mainly consists of geriatric assessment, Vivifrail multicomponent exercise, nutritional intervention, cognitive prehabilitation and brain protection.

Combination Product: Multimodal prehabilitation combined with perioperative ERAS care（PREERAS）

Control group

NO INTERVENTION

The control group will receive standard of enhanced recovery after surgery (ERAS) care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation

Interventions

Multimodal prehabilitation combined with perioperative ERAS care（PREERAS） COMBINATION_PRODUCT

Pre-admission risk assessment and targeted intervention provided by multidisciplinary team

PREERAS group

Eligibility Criteria

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

You may qualify if:

• patients who voluntarily sign the informed consent form; (2) elective spinal fusion surgery for degenerative spinal disorders; (3) no severe cognitive impairment (MoCA score ≥ 8).

You may not qualify if:

• Patients (1) are scheduled to undergo emergency or day surgery,
• have urgent condition that needs to be managed before the surgery,
• are unable to cooperate with preoperative assessment,
• have spinal fractures, metastasis, and spinal infections,
• unable to understand or participate safely in intervention program,
• participate in another study that may affect the study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 10034, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 10050, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 10053, China

Location

Related Publications (10)

• Kassebaum DG, Judkins MP, Griswold HE. Stress electrocardiography in the evaluation of surgical revascularization of the heart. Circulation. 1969 Sep;40(3):297-313. doi: 10.1161/01.cir.40.3.297. No abstract available.

  PMID: 5810888 BACKGROUND

• Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.

  PMID: 30074971 BACKGROUND

• Rivier C, Shen GH. In the rat, endogenous nitric oxide modulates the response of the hypothalamic-pituitary-adrenal axis to interleukin-1 beta, vasopressin, and oxytocin. J Neurosci. 1994 Apr;14(4):1985-93. doi: 10.1523/JNEUROSCI.14-04-01985.1994.

  PMID: 8158253 BACKGROUND

• Karsy M, Chan AK, Mummaneni PV, Virk MS, Bydon M, Glassman SD, Foley KT, Potts EA, Shaffrey CI, Shaffrey ME, Coric D, Asher AL, Knightly JJ, Park P, Fu KM, Slotkin JR, Haid RW, Wang M, Bisson EF. Outcomes and Complications With Age in Spondylolisthesis: An Evaluation of the Elderly From the Quality Outcomes Database. Spine (Phila Pa 1976). 2020 Jul 15;45(14):1000-1008. doi: 10.1097/BRS.0000000000003441.

  PMID: 32097272 BACKGROUND

• Whittle AK, Kalsi T, Babic-Illman G, Wang Y, Fields P, Ross PJ, Maisey NR, Hughes S, Kwan W, Harari D. A comprehensive geriatric assessment screening questionnaire (CGA-GOLD) for older people undergoing treatment for cancer. Eur J Cancer Care (Engl). 2017 Sep;26(5). doi: 10.1111/ecc.12509. Epub 2016 May 1.

  PMID: 27132979 BACKGROUND

• Parker SG, McCue P, Phelps K, McCleod A, Arora S, Nockels K, Kennedy S, Roberts H, Conroy S. What is Comprehensive Geriatric Assessment (CGA)? An umbrella review. Age Ageing. 2018 Jan 1;47(1):149-155. doi: 10.1093/ageing/afx166.

  PMID: 29206906 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• McIsaac DI, Gill M, Boland L, Hutton B, Branje K, Shaw J, Grudzinski AL, Barone N, Gillis C; Prehabilitation Knowledge Network. Prehabilitation in adult patients undergoing surgery: an umbrella review of systematic reviews. Br J Anaesth. 2022 Feb;128(2):244-257. doi: 10.1016/j.bja.2021.11.014. Epub 2021 Dec 16.

  PMID: 34922735 BACKGROUND

• Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7.

  PMID: 35012741 BACKGROUND

• Wang SK, Wang P, Wang W, Lu S. Multimodal prehabilitation combined with perioperative enhanced recovery after surgery care for older patients undergoing spinal fusion surgery in China: protocol for a multicentre randomised controlled trial (PRACTICE trial). BMJ Open. 2024 Dec 11;14(12):e088339. doi: 10.1136/bmjopen-2024-088339.

  PMID: 39663170 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shibao Lu

  Xuanwu Hospital, Beijing

  STUDY CHAIR

• Shuaikang Wang

  Capital Medical University

  STUDY DIRECTOR

• Chun-De Li

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Yong Yang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

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: November 8, 2023
• First Posted: November 20, 2023
• Study Start: April 15, 2024
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)