Degenerative Spinal DiseaseNCT06607081
Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
A study testing Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention in people with Degenerative Spinal Disease and Elderly Patients, run by Xijing Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Degenerative Spinal Disease, Elderly Patients, Spinal Fusion Acquired
- What is being tested?
- Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 2 sitesChina
- Study dates
- 15 Oct 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1.Age ≥75 years old;
- 2.Have degenerative spinal diseases, including cervical, thoracic and lumbar spine diseases;
- 3.With severe neurological symptoms fail to conservative treatment and have to undergo the spinal fusion surgery;
- 4.No serious cognitive impairment (MoCA score ≥8);
- 5.No surgical contraindications;
- 6.Anesthesia assessment patients can safely undergo surgery;
- 7.Patients who voluntarily participate in and sign informed consent, can independently complete effective questionnaires, and are willing to follow up according to clinical requirements.
Who cannot join
- 1.Patients who could not cooperate with doctors to complete preoperative evaluation and postoperative follow-up;
- 2.Patients requiring spinal intervention due to spinal infection, fracture or metastatic disease;
- 3.Patients with cerebrovascular accidents in the last 30 days;
- 4.Patients with hepatic encephalopathy or acute active hepatitis;
- 5.Patients with severe renal insufficiency with creatinine>2.5mg/dL or undergoing hemodialysis;
- 6.Patients with severe lung and cardiovascular diseases, coagulation disorders, and anesthesia contraindications;
Show all 10Show fewer
- 7.Patients with poorly controlled diabetes (HBAlc>8.0%);
- 8.Patients who are participating in clinical trials of other drugs or medical devices;
- 9.Patients requiring emergency surgery;
- 10.Patients who are considered by the investigator to be unable to participate in this clinical trial due to other circumstances.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Xijing Hospital
Xi'an, Shaanxi, 710032
Lianghua Chen, 86-029-84771794, wuzixiang@fmmu.edu.cn
Yanyan Jia, MD, 86-29-84771794
Xijing Hospital
Xi'an, Shaanxi, 710032
Yanyan Jia, MD, 86-29-84771794, xjyyllwyh@163.com
Zixiang Wu, MD
About this study
Official title: The Preoperative Risk Evaluation and Perioperative ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
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.
Read the detailed description
Population ageing is rapid progressing globally. In the United States, the number of people over the age of 80 is expected to grow from 1.9% in 2020 to 4.3% in 2050. According to the Statistical Communique on the Development of Civil Affairs in 2023 issued by the Ministry of Civil Affairs in 2024, the elderly population aged 65 and above in China is 216.76 million, accounting for 15.4% of the total population. Spinal degenerative diseases are the most common diseases among the elderly population. The prevalence of spinal degenerative diseases over 65 years old is about 56%, and there are about 121 million patients in China. Spinal degenerative diseases, including cervical spondylosis, cervical spinal stenosis, lumbar disc herniation, lumbar spinal stenosis, degenerative scoliosis, et al., which can lead to significant nerve compression, pain, neurological dysfunction, and mobility and endurance reduction, leading to reduced quality of life. Elderly patients preferentially choose non-surgical treatment such as drug intervention, but most conservative treatment methods have limited efficacy and cannot completely relieve nerve compression. Spinal fusion surgery is the most fundamental solution to the treatment of spinal degenerative diseases. Because of the elderly patients with multiple diseases, multi-drug use, multi-organ dysfunction, therefore, the perioperative safety management of such patients is a difficult problem faced by clinicians.
Preoperative high-risk factor evaluation and pre-enhanced recovery after surgery (Pre ERAS) are effective preoperative optimization strategies to benefit elderly patients. Patients are comprehensively evaluated before surgery by multidisciplinary consultation group to assess the high risk factors of spinal fusion surgery. On this basis, multidisciplinary intervention, exercise, nutritional support and psychological intervention were carried out to increase patients' preoperative physiological reserve, reduce the incidence of postoperative adverse events, and ultimately improve patients' perioperative functional status and prognosis. However, there is still a significant lack of unified understanding and willingness to implement preoperative screening and surgical management for elderly patients.
On the basis of "Chinese Expert Consensus on Multidisciplinary Evaluation of Perioperative Period in Elderly Spinal Surgery Patients", this study intends to further specify the concept of Pre ERAS for diagnosis and treatment measures, and form an operable Pre ERAS protocol. Through multi-center, prospective clinical study, to comprehensively evaluate the comprehensive impact of preoperative high-risk factor assessment combined with Pre ERAS measures on the clinical prognosis of elderly patients undergoing spinal fusion surgery, which lays an evidence-based medical foundation for the extensive application of this concept and measures in clinical practice.
The overall aim of this work is to evaluate the effects of preoperative risk factors and Pre ERAS on clinical outcomes in elderly (≥75 years) spinal fusion patients.
This study is a multi-center, prospective, randomized controlled clinical trial including a total of 2500 patients in the experimental group and the control group, respectively. The research centers include: Shenzhen Hospital of Southern Medical University, the Second Xiangya Hospital of Central South University, and Shanghai General Hospital. Patients were recruited according to inclusion criteria and exclusion criteria. The experimental group received Pre ERAS during perioperative period, while the control group received conventional ERAS during perioperative period. According to the clinical study protocol, patients were subjected to perioperative intervention, clinical follow-up, results recorded, adverse events were discovered and recorded in time and reported according to regulations, and cases meeting the exclusion criteria were excluded. This study will start in October 2024. The recruitment period will be 12 months, with a follow-up of 12 months. The results of the study will be expected in October 2027.
- Being tested
- Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention
- Keywords
- Elderly patients, ERAS, Spinal disease, Surgical intervention, Risk factors
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS interventionCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Pre ERAS group | Experimental | Not described Receives: Combination Product: Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks postoperation
Secondary outcomes (9)
Neck disability index (NDI) score/Oswestry disability index (ODI) score
The Neck disability index (NDI) score reflects the neck-related functional status of patients with cervical spine pathology and response to the surigcal treatment. The NDI score is assessed using NDI questionnaire and the total NDI score ranges from 0 to 50 points, with the highest socre (50 pionts) means complete disability and the lowest socre (0 points) means no disability.
The Oswestry disability index (ODI) score reflects back-related functional status of patients with lumbar spine pathology and response to the surgical treatment. The ODI score is assessed using ODI questionnaire. The total ODI score is reported from 0 to 100, with the higher score reflects higher disability and lower functional status, while the lower score reflects lower disability and higher functional status.
Measured: 24 weeks postoperation
North American Spine Satisfaction (NASS) Score
The patient satisfaction after spinal fusion intervention is assessed using North American Spine Satisfaction (NASS) questionnaire. NASS score ranges from 1 to 4, the lowest score means the highest level of satisfication while the highest score means the lowest level of satisfication.
Score 1 is defined as "Surgery met my expectations." Score 2 is defined as "I did not improve as much as I had hoped but I would undergo the same operation for the same results." Score 3 is defined as "Surgery helped but I would not undergo the same operation for the same results," Score 4 is defined as "I am the same or worse as compared to before surgery."
Measured: 24 weeks postoperation
Japanese Orthopaedic Association (JOA) score
The severity of cervical compression myelopathy before and after surgery of the patients is evaluated using the Japanese Orthopaedic Association (JOA) scale, with the total JOA score ranges from 0 to 17. If the JOA score is larger than 13, the severity defines as mild. If the JOA score is 9~13, the severity defines as moderate. If the JOA score is less than 9, the severity defines as severe.
Measured: 24 weeks postoperation
Bone minral density (BMD) evaluation
The bone minral density (BMD) will be tested using Dual Energy X-ray Absorptiometry (DEXA) to assess the bone quality of the patients included in this study before and after spinal fusion intervention.
Measured: 24 weeks postoperation
Spinal fusion rates
The spinal fusion is evatluted by compute tomography (CT) scanning to reflects the effectiveness of Pre ERAS on bone healing after surgical intervention.
The spinal fusion criteria is defined as the continuous callus is detected on CT radiograph at the surgical intervented spinal segments.
The spinal fusion rates is calculated as the number of the fused setgments after surgical intervention divided by the number of the total surgical intervented segments.
Measured: 24 weeks postoperation
Length of hospital stay
The length of hospital stay is the total time of the patient spended in hospital for medical treatment. This time starts from patient admission and ended when patient discharge.
The discharge criteria:
- The patient satified with the outcomes of spinal fusion intervention;
- The spinal fusion intervention achieved peroperative symptoms relive and function recovery;
- No further medical intervention is needed;
- No surgerical complications;
Measured: 2 weeks postoperation
Discharge rate
Measured: 2 weeks postoperation
Readmission rate
Measured: 4 weeks postoperation
90-day unplanned readmission rates
Any admission which was within 90 days of the previous discharge (index admission) was counted as 90-day unplanned readmission.
Measured: 90 days postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Degenerative Spinal DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Second Xiangya Hospital of Central South University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607081
- Sponsor's protocol ID
- KY20242310wuzixiang
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28970074Kim 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.
PubMed 32077417Kim 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.
PubMed 34614555Carlstrom 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.
PubMed 34656260Debono 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.
PubMed 30933923van 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.
PubMed 30670009Soffin 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.
PubMed 32433277
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preoperative Risk Evaluation and Perioperative ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT06607081
- Acronym / sponsor ID
- KY20242310wuzixiang
- Keywords
- Elderly patients, ERAS, Spinal disease, Surgical intervention, Risk factors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Second Xiangya Hospital of Central South University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Population ageing is rapid progressing globally. In the United States, the number of people over the age of 80 is expected to grow from 1.9% in 2020 to 4.3% in 2050. According to the Statistical Communique on the Development of Civil Affairs in 2023 issued by the Ministry of Civil Affairs in 2024, the elderly population aged 65 and above in China is 216.76 million, accounting for 15.4% of the total population. Spinal degenerative diseases are the most common diseases among the elderly population. The prevalence of spinal degenerative diseases over 65 years old is about 56%, and there are about 121 million patients in China. Spinal degenerative diseases, including cervical spondylosis, cervical spinal stenosis, lumbar disc herniation, lumbar spinal stenosis, degenerative scoliosis, et al., which can lead to significant nerve compression, pain, neurological dysfunction, and mobility and endurance reduction, leading to reduced quality of life. Elderly patients preferentially choose non-surgical treatment such as drug intervention, but most conservative treatment methods have limited efficacy and cannot completely relieve nerve compression. Spinal fusion surgery is the most fundamental solution to the treatment of spinal degenerative diseases. Because of the elderly patients with multiple diseases, multi-drug use, multi-organ dysfunction, therefore, the perioperative safety management of such patients is a difficult problem faced by clinicians.
Preoperative high-risk factor evaluation and pre-enhanced recovery after surgery (Pre ERAS) are effective preoperative optimization strategies to benefit elderly patients. Patients are comprehensively evaluated before surgery by multidisciplinary consultation group to assess the high risk factors of spinal fusion surgery. On this basis, multidisciplinary intervention, exercise, nutritional support and psychological intervention were carried out to increase patients' preoperative physiological reserve, reduce the incidence of postoperative adverse events, and ultimately improve patients' perioperative functional status and prognosis. However, there is still a significant lack of unified understanding and willingness to implement preoperative screening and surgical management for elderly patients.
On the basis of "Chinese Expert Consensus on Multidisciplinary Evaluation of Perioperative Period in Elderly Spinal Surgery Patients", this study intends to further specify the concept of Pre ERAS for diagnosis and treatment measures, and form an operable Pre ERAS protocol. Through multi-center, prospective clinical study, to comprehensively evaluate the comprehensive impact of preoperative high-risk factor assessment combined with Pre ERAS measures on the clinical prognosis of elderly patients undergoing spinal fusion surgery, which lays an evidence-based medical foundation for the extensive application of this concept and measures in clinical practice.
The overall aim of this work is to evaluate the effects of preoperative risk factors and Pre ERAS on clinical outcomes in elderly (≥75 years) spinal fusion patients.
This study is a multi-center, prospective, randomized controlled clinical trial including a total of 2500 patients in the experimental group and the control group, respectively. The research centers include: Shenzhen Hospital of Southern Medical University, the Second Xiangya Hospital of Central South University, and Shanghai General Hospital. Patients were recruited according to inclusion criteria and exclusion criteria. The experimental group received Pre ERAS during perioperative period, while the control group received conventional ERAS during perioperative period. According to the clinical study protocol, patients were subjected to perioperative intervention, clinical follow-up, results recorded, adverse events were discovered and recorded in time and reported according to regulations, and cases meeting the exclusion criteria were excluded. This study will start in October 2024. The recruitment period will be 12 months, with a follow-up of 12 months. The results of the study will be expected in October 2027.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative Pre ERAS group | Experimental | Combination Product: Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 1.Age ≥75 years old;
- 2.Have degenerative spinal diseases, including cervical, thoracic and lumbar spine diseases;
- 3.With severe neurological symptoms fail to conservative treatment and have to undergo the spinal fusion surgery;
- 4.No serious cognitive impairment (MoCA score ≥8);
- 5.No surgical contraindications;
Key exclusion criteria (10 listed)
- 1.Patients who could not cooperate with doctors to complete preoperative evaluation and postoperative follow-up;
- 2.Patients requiring spinal intervention due to spinal infection, fracture or metastatic disease;
- 3.Patients with cerebrovascular accidents in the last 30 days;
- 4.Patients with hepatic encephalopathy or acute active hepatitis;
- 5.Patients with severe renal insufficiency with creatinine>2.5mg/dL or undergoing hemodialysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS interventionThe 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. | Combination product | Perioperative Pre ERAS group |
Primary outcome
Comprehensive Complication Index
Time frame: 24 weeks postoperation
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.
9 secondary outcomes
Neck disability index (NDI) score/Oswestry disability index (ODI) score
Time frame: 24 weeks postoperation
North American Spine Satisfaction (NASS) Score
Time frame: 24 weeks postoperation
Japanese Orthopaedic Association (JOA) score
Time frame: 24 weeks postoperation
Bone minral density (BMD) evaluation
Time frame: 24 weeks postoperation
Spinal fusion rates
Time frame: 24 weeks postoperation
Length of hospital stay
Time frame: 2 weeks postoperation
Discharge rate
Time frame: 2 weeks postoperation
Readmission rate
Time frame: 4 weeks postoperation
90-day unplanned readmission rates
Time frame: 90 days postoperation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 28970074Chotai 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.
- Background: PubMed 32077417Kim 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.
- Background: PubMed 34614555Kim 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.
- Background: PubMed 34656260Carlstrom 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.
- Background: PubMed 30933923Debono 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.
- Background: PubMed 30670009van 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.
- Background: PubMed 32433277Soffin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Preoperative Risk Evaluation and the Corresponded Pre ERAS intervention in people with Degenerative Spinal Disease and Elderly Patients, run by Xijing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianwen Gao, MD (+86-29-84771794, xjyyllwyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (time frame: 24 weeks postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607081, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.