Back to resultsEstablishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
Primary Purpose
Tumor of Spinal Cord
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Postoperative rehabilitation nursing
Sponsored by
About this trial
This is an interventional supportive care trial for Tumor of Spinal Cord focused on measuring early rehabilitation training
Eligibility Criteria
Inclusion Criteria:
- Patients with primary benign intraspinal tumors at the level of L1-L5 who underwent semi laminectomy;
- The age of the patients ranged from 14 to 80 years old;
- 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:
- patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal;
- Have a history of severe hypertension, heart disease or other mental illness;
- Patients with major organ damage or coagulation dysfunction;
- The patients and their family members had poor communication and compliance;
- There are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);
Sites / Locations
- Wangping NeurosurgicalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group A
intervention group B
Arm Description
routine nursing after operation
Nursing care after operation with stage intervention
Outcomes
Primary Outcome Measures
Patient rehabilitation and leave hospital
The whole clinical courses were strictly controlled in quality so as to compare the average length of stay (days) in the two groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT04968730
First Posted
June 1, 2021
Last Updated
July 8, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04968730
Brief Title
Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
Official Title
Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor of Spinal Cord
Keywords
early rehabilitation training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The routine group was given routine nursing, and the control group was given early rehabilitation nursing
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group A
Arm Type
Placebo Comparator
Arm Description
routine nursing after operation
Arm Title
intervention group B
Arm Type
Experimental
Arm Description
Nursing care after operation with stage intervention
Intervention Type
Other
Intervention Name(s)
Postoperative rehabilitation nursing
Intervention Description
Make postoperative rehabilitation plan according to nursing experience for group A Develop rehabilitation process according to the activity plan for group B
Primary Outcome Measure Information:
Title
Patient rehabilitation and leave hospital
Description
The whole clinical courses were strictly controlled in quality so as to compare the average length of stay (days) in the two groups.
Time Frame
up to two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with primary benign intraspinal tumors at the level of L1-L5 who underwent semi laminectomy;
The age of the patients ranged from 14 to 80 years old;
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:
patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal;
Have a history of severe hypertension, heart disease or other mental illness;
Patients with major organ damage or coagulation dysfunction;
The patients and their family members had poor communication and compliance;
There are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);
Facility Information:
Facility Name
Wangping Neurosurgical
City
Hangzhou
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ping wang, Bachelor
Phone
13588203480
Email
tai3480@dingtalk.com
12. IPD Sharing Statement
Learn more about this trial
Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
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