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Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection

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ClinicalTrials.gov Identifier: NCT04968730
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:

Objective to construct the related early activity program for patients with lumbar intraspinal tumor after hemilaminectomy, and evaluate the postoperative limb function exercise according to the content of the program. In order to improve the self-care ability and quality of life of patients, reduce postoperative complications, shorten the average length of stay, reduce hospitalization expenses and improve patient satisfaction.

Objective to evaluate the efficacy and safety of establishing early activity program after hemilaminectomy for patients with lumbar intraspinal tumors


Condition or disease Intervention/treatment Phase
Tumor of Spinal Cord Other: Postoperative rehabilitation nursing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The routine group was given routine nursing, and the control group was given early rehabilitation nursing
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Placebo Comparator: control group A
routine nursing after operation
Other: Postoperative rehabilitation nursing
Make postoperative rehabilitation plan according to nursing experience for group A Develop rehabilitation process according to the activity plan for group B

Experimental: intervention group B
Nursing care after operation with stage intervention
Other: Postoperative rehabilitation nursing
Make postoperative rehabilitation plan according to nursing experience for group A Develop rehabilitation process according to the activity plan for group B




Primary Outcome Measures :
  1. Patient rehabilitation and leave hospital [ Time Frame: up to two years ]
    The whole clinical courses were strictly controlled in quality so as to compare the average length of stay (days) in the two groups.



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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with primary benign intraspinal tumors at the level of L1-L5 who underwent semi laminectomy;
  2. The age of the patients ranged from 14 to 80 years old;
  3. The GCS score was 15 points, and the lower limb muscle strength was more than or equal to grade 3 before operation; The patients agreed to the operation and were willing to accept and cooperate with the concept of early rehabilitation nursing and related measures;

Exclusion Criteria:

  1. patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal;
  2. Have a history of severe hypertension, heart disease or other mental illness;
  3. Patients with major organ damage or coagulation dysfunction;
  4. The patients and their family members had poor communication and compliance;
  5. There are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968730


Locations
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China
Wangping Neurosurgical Recruiting
Hangzhou, China, 310000
Contact: ping wang, Bachelor    13588203480    tai3480@dingtalk.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04968730    
Other Study ID Numbers: 2021-0116
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
early rehabilitation training
Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Spinal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Central Nervous System Diseases
Bone Neoplasms
Spinal Cord Diseases
Nervous System Diseases
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases