NCT04110457

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

2.5 years

First QC Date

September 27, 2019

Last Update Submit

December 23, 2022

Conditions

Spinal Metastases

Outcome Measures

Primary Outcomes (1)

  • Evaluate quality of life after surgery

    to evaluate the general condition using 5Q-ED score

    baseline

Secondary Outcomes (1)

  • to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases.

    Baseline

Interventions

spinal decompressionPROCEDURE

spinal surgery by decompression or fixation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with spinal metastases

You may qualify if:

  • Patients \> 18 years old
  • Patient with tissue proven dx of cancer

You may not qualify if:

  • Patient younger 18 years old
  • CNS or spinal 1ry tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 12518372BACKGROUND

  • 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.

    PMID: 22312491RESULT

MeSH Terms

Interventions

Laminectomy

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Essam El morshidy, PHD

    lecturer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 1, 2019

Study Start

April 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

December 28, 2022

Record last verified: 2022-12

Locations

EG(1)