Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery
Primary Purpose
Spinal Metastases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
open surgery
Minimal access surgery
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Metastases focused on measuring spinal metastases, spine surgery, metastatic spinal cord compression, EQ-5D, HRQOL
Eligibility Criteria
Inclusion Criteria:
- Metastatic spinal cord compression with a metastasis from Th5-L3 Tokuhashi above 4
Exclusion Criteria:
- Need for radical treatment and not only palliative
- Need for surgical stabilization in a region lower then L3
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
open surgery
Minimal access surgery
Arm Description
One arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation.
We compare to well-known types of surgery for metastatic spinal cord compression. The other arm receive open surgery. In our department minimal access surgery is considered as a standard procedure but it is not preformed by all spine surgeons.
Outcomes
Primary Outcome Measures
Bleeding
The investigators compare the bleeding for each treatment modality during the operation.
Secondary Outcome Measures
Health related quality of life measured with questionnaire EQ-5D and QLQ-C30
The EORTC EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01865942
Brief Title
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery
Official Title
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 28, 2014 (Actual)
Primary Completion Date
January 2, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators wish to evaluate the effect of minimal access spinal surgery compared to traditional open surgery spinal surgery in patients with metastatic spinal cord compression.
Minimal access surgery has been shown to bee less damaging for the tissue compared to traditional open surgery and also cause fewer wound complications, the investigators expect the above could have impact in a vulnerable patient group like patients with metastatic spinal cord compression.
Detailed Description
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial
Purpose To investigate the effect of minimal access spine surgery (MASS) compared with conventional open surgery in the treatment of patients with metastatic spinalcord compression (MSCC).
Hypotheses The group of patient's receiving MASS will have better improvement in quality after surgery compared to the group that will receive traditional open surgery. The MASS patient group will have reduction in per-operative bleeding and less wound complications needing surgical revision compered to the group of patients receiving open or traditional surgery.
Primary outcome Perioperative bleeding.
Secondary outcomes Quality of life and incidence of revision surgery.
Material and method A randomised controlled trial with a 1-year follow up will be conducted.
Sample size From previous studies and based patient files it is calculated that the mean blood loss during open surgery is 1500 ml (standard deviation 750 ml). A clinical relevant reduction in blood loss will be 400 ml corresponding to one unit of packed red blood cells.
With a significance level of 5% and a power of 80% a total of 62 patients have to be included in the study.
Most studies using QLQ-C30 as a measurement for health related quality of life (HRQL) in randomized comparison of treatment modalities in cancer patients have included between 100 and 200 patients. This includes studies where both QLQ-C30 and EQ-5D have been used. EQ-5D is widely used as a generic measurement of HRQL.
62 patients will be randomly allocated to receive either minimal invasive or open surgery. Inclusion criteria are patients with spinal metastases at level Th5-L3 who are candidates for surgery. Exclusion criteria are: Tokuhashi score ≤ 4, preoperative presumptions that something else than pedicle screws would be needed, potentially the need for sacral or iliosacral instrumentation, and patients who need more radical treatment. The QLQ-C30 (Quality of Life Cancer) will be assessed since this instrument is especially developed for use in cancer patients and will be used as a clinical measure.
Outcome measure on bleeding will be recorded during the operation. Outcome measures on quality of life will be estimated with QLQ-C30, EQ-5D and VAS-pain score. This will be recorded before operation, by time of discharge, 6 weeks and 3, 6 and 12 months after the operation. Records on wound complications leading to an intervention of revision-surgery, antibiotics or other procedures are registered at the same follow up times.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
spinal metastases, spine surgery, metastatic spinal cord compression, EQ-5D, HRQOL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open surgery
Arm Type
Active Comparator
Arm Description
One arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation.
Arm Title
Minimal access surgery
Arm Type
Active Comparator
Arm Description
We compare to well-known types of surgery for metastatic spinal cord compression. The other arm receive open surgery. In our department minimal access surgery is considered as a standard procedure but it is not preformed by all spine surgeons.
Intervention Type
Procedure
Intervention Name(s)
open surgery
Intervention Description
The to surgical procedures are individually well know, but the outcome of the procedures in respect to perioperative bleeding and change in quality of life has to our knowledge not been compared.
Intervention Type
Procedure
Intervention Name(s)
Minimal access surgery
Intervention Description
The to surgical procedures are individually well know, but the outcome of the procedures in respect to perioperative bleeding and change in quality of life has to our knowledge not been compared.
Primary Outcome Measure Information:
Title
Bleeding
Description
The investigators compare the bleeding for each treatment modality during the operation.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Health related quality of life measured with questionnaire EQ-5D and QLQ-C30
Description
The EORTC EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
Time Frame
before intervention and six months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic spinal cord compression with a metastasis from Th5-L3 Tokuhashi above 4
Exclusion Criteria:
Need for radical treatment and not only palliative
Need for surgical stabilization in a region lower then L3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Schmidt Morgen, MD
Organizational Affiliation
Spine Section, Department of Orthopedic Surgery, Copenhagen University Hospital, Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19399538
Citation
Rodriguez-Vela J, Lobo-Escolar A, Joven-Aliaga E, Herrera A, Vicente J, Sunen E, Loste A, Tabuenca A. Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion. Eur Spine J. 2009 Aug;18(8):1194-201. doi: 10.1007/s00586-009-1010-0. Epub 2009 Apr 28.
Results Reference
background
PubMed Identifier
17108840
Citation
Falicov A, Fisher CG, Sparkes J, Boyd MC, Wing PC, Dvorak MF. Impact of surgical intervention on quality of life in patients with spinal metastases. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2849-56. doi: 10.1097/01.brs.0000245838.37817.40.
Results Reference
background
PubMed Identifier
16540878
Citation
Kim KT, Lee SH, Suk KS, Bae SC. The quantitative analysis of tissue injury markers after mini-open lumbar fusion. Spine (Phila Pa 1976). 2006 Mar 15;31(6):712-6. doi: 10.1097/01.brs.0000202533.05906.ea.
Results Reference
background
PubMed Identifier
17041505
Citation
Ringel F, Stoffel M, Stuer C, Meyer B. Minimally invasive transmuscular pedicle screw fixation of the thoracic and lumbar spine. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS361-6; discussion ONS366-7. doi: 10.1227/01.NEU.0000223505.07815.74.
Results Reference
background
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Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery
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