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Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery

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ClinicalTrials.gov Identifier: NCT01865942
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Søren Schmidt Morgen, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Spinal Metastases Procedure: open surgery Procedure: Minimal access surgery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.
Actual Study Start Date : August 28, 2014
Actual Primary Completion Date : January 2, 2017
Actual Study Completion Date : March 30, 2017

Arm Intervention/treatment
Active Comparator: open surgery
One arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation.
Procedure: open surgery
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.

Active Comparator: Minimal access surgery
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.
Procedure: Minimal access surgery
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 Measures :
  1. Bleeding [ Time Frame: intraoperative ]
    The investigators compare the bleeding for each treatment modality during the operation.


Secondary Outcome Measures :
  1. Health related quality of life measured with questionnaire EQ-5D and QLQ-C30 [ Time Frame: before intervention and six months follow up ]

    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.




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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01865942


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Søren Schmidt Morgen, MD Spine Section, Department of Orthopedic Surgery, Copenhagen University Hospital, Rigshospitalet

Publications:
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Responsible Party: Søren Schmidt Morgen, Medical doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01865942     History of Changes
Other Study ID Numbers: H-2-2011-050
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Søren Schmidt Morgen, Rigshospitalet, Denmark:
spinal metastases
spine surgery
metastatic spinal cord compression
EQ-5D
HRQOL
Additional relevant MeSH terms:
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Neoplasm Metastasis
Spinal Cord Compression
Neoplastic Processes
Neoplasms
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries