SYSTEMATIC REVIEW OF SCIENTIFIC LITERATURE ON THE EFFICACY,
SAFETY, EFFECTIVENESS AND EFFICIENCY OF ALTERNATIVE SURGICAL
TECHNIQUES TO TRADITIONAL SURGERY FOR DISC HERNIA
Title.
Efficacy, safety, effectiveness and efficiency
of innovative surgical techniques as alternatives to conventional
surgery: a systematic review of the scientific literature.
Background.
Available scientific evidence shows that
in disc hernias where there is criteria to recommend surgery,
it is effective. The techniques usually used for the surgical
treatment of these disc hernias essentially include micro-discectomy,
discectomy, hemi-laminotomy, hemi-laminectomy, arthrodesis
and various combinations of the above.
However, in recent years new surgical techniques have been
defined for disc fissures, protrusions and hernias, such as
chemical nucleolysis, percutaneous nucleotomy, placement of
a prosthesis of nucleus pulposus, antibiotic therapy, intradiscal
electro-thermal therapy (IDET) and ozone therapy.
The use of these techniques is wide spread and they are even
applied to patients in the clinical setting, despite the fact
that to date there is still no systematic review of the scientific
evidence demonstrating their efficacy, safety, effectiveness
or efficiency.
Objective.
To find and analyze the existing scientific
literature on the effectiveness of surgery in comparison with
the conservative treatment for symptomatic lumbar spinal stenosis
and summarize it into a solid recommendation.
Methodology.
It was a systematic review and meta-analysis
of the scientific literature. All of the randomized clinical
trials in one or several of the new surgical techniques for
disc hernia (defined as chemical nucleolysis, percutaneous
nucleotomy, placement of prosthesis of the nucleus pulposus,
antibiotic therapy, intradiscal electro-thermal therapy (IDET)
and ozone therapy).
To find these studies, electronic and additional search strategies
were used in order to identify potential studies that had
not been gathered in these bases.
The methodological quality of each one of the studies found
was studied and a sensitivity analysis was conducted to explore
the possible relation between quality and the results of each
study. The evaluation of the scientific quality of each study
included aspects of methodological quality (such as those
relating to the design of the clinical trial, in accordance
with the established standards of the international scientific
community), and clinical or technical quality (related to
the use of the different surgical techniques and the selection
of their appropriateness, as were described in each study).
The scientific quality of each study was appraised by two
independent reviewers in order to guarantee greater rigor
in their appraisals. In the cases where they disagreed, a
joint discussion was held and a final consensus was reached,
with the contribution of the rest of the researchers in those
cases where needed.
The characteristics of all the identified clinical trials
were described structurally and an overall appraisal of the
effect of each surgery technique was made by means of the
OR (odds ratio) or when the studied effects were very frequent,
using the RR (relative risk), calculated by means of the Revman
or Stata programs. Both the absolute measures of the effect
as well as the necessary number of patients to treat in order
to observe the desired effect (NNT) were calculated.
Participants, along with the Foundation's
Science Department.
Cochrane Iberoamerican Center and the Department
of Neurosurgery and the Spine Unit of the Traumatology Department
at the Hospital de Son Dureta, and the Spine Unit at the Hospital
Vall d'Hebrón.
The study was co-funded by the Agency of Evaluation of Health
Technologies and the Kovacs Foundation.
Status.
In progress.
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