- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110457
Outcomes of Surgical Treatment of Patients With Spinal Metastasis in AUH
December 23, 2022 updated by: Karim gamal asem, Assiut University
Outcomes of Surgical Treatment of Patients With Spinal Metastasis in Assiut University Hospitals
To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
this study monitor what is the results after operative treatment of patients which have secondary metastases in spinal column concerning quality of live for one year and pain and neurology
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Assuit University
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Assuit, Egypt
- Assuit University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with spinal metastases
Description
Inclusion Criteria:
- Patients > 18 years old
- Patient with tissue proven dx of cancer
Exclusion Criteria:
- Patient younger 18 years old
- CNS or spinal 1ry tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate quality of life after surgery
Time Frame: baseline
|
to evaluate the general condition using 5Q-ED score
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases.
Time Frame: Baseline
|
evaluation of postoperative pain and neurology and comparing with preoperative data
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Essam El morshidy, PHD, Lecturer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hirabayashi H, Ebara S, Kinoshita T, Yuzawa Y, Nakamura I, Takahashi J, Kamimura M, Ohtsuka K, Takaoka K. Clinical outcome and survival after palliative surgery for spinal metastases: palliative surgery in spinal metastases. Cancer. 2003 Jan 15;97(2):476-84. doi: 10.1002/cncr.11039.
- Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
September 27, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (Actual)
October 1, 2019
Study Record Updates
Last Update Posted (Actual)
December 28, 2022
Last Update Submitted That Met QC Criteria
December 23, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- surgical treatment in spine
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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