Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery
Condition: Spinal Metastases
MeSH terms: Neoplasm Metastasis; Spinal Cord Compression
Study type: Interventional

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.
    

Intervention name(s): open surgery; Minimal access surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal metastases; spine surgery; metastatic spinal cord compression; EQ-5D; HRQOL