Diagnostic et traitement des varices des membres inférieurs - KCE
Diagnostic et traitement des varices des membres inférieurs - KCE
Diagnostic et traitement des varices des membres inférieurs - KCE
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20 Varicose Veins <strong>KCE</strong> Reports 164<br />
4.1.2 Randomised controlled trials<br />
4.1.2.1 Identified studies<br />
The literature search for relevant RCTs was carried out in February 2011 identifying<br />
1913 citations (figure 4). An additional recently published RCT 71 was identified by one<br />
of the experts. The majority of citations were excluded on the basis of title and<br />
abstract; the other papers (n=42) were r<strong>et</strong>rieved in full and reviewed in more d<strong>et</strong>ail.<br />
In addition, three potentially relevant trials (NCT00621062, NCT00529672, and<br />
NCT01103258) were identified in the ClinGov website (www.clinicaltrials.gov). The<br />
investigators were contacted to find out when the results of these ongoing trials would<br />
be published.<br />
Three RCTs were excluded from the analysis because they had already been discussed<br />
in the previous phase on systematic reviews. On the basis of the full text, nine other<br />
studies were excluded: eight were not RCTs and one lacked a comparator group.<br />
Therefore, 30 RCTs were assessed for their m<strong>et</strong>hodological quality.<br />
4.1.2.2 Results of quality appraisal for RCTs<br />
The majority of RCTs (n=24) were judged to have a low risk of bias and six RCTs high<br />
risk of bias (see appendix 9.5).<br />
Exclusion of 6 RCTs with high risk of bias<br />
Six RCTs 72-77 had a high risk of bias because authors did not report on the m<strong>et</strong>hod of<br />
randomisation, the baseline characteristics of patient groups, or patient drop outs<br />
during the study:<br />
• Two RCTs on sclerotherapy: Hamel-Desnos (2010) 74 ,Yamaki (2009) 77 ;<br />
• Two RCTs on EVLT: Maurins (2009) 75 ,Theivacumar (2008) 76 ;<br />
• One RCT with EVLT versus RFA: Gale (2010) 73 ;<br />
• One RCT on surgery (comparison of 2 stripping techniques): Assadian<br />
(2008) 72 .<br />
24 RCTs with low risk of bias<br />
Twenty-four RCTs had a low risk of bias 71 78-100 .<br />
4.1.2.3 Final selection: 15 relevant RCTs<br />
However nine of the 24 RCTs were further excluded as the interventions were not<br />
relevant for this review:<br />
• Two RCTs 97 98 evaluated the surgical technique CHIVA, a procedure not<br />
currently used in Belgium;<br />
• Three RCTs 91 100 evaluated the technique of cryostripping, also not currently<br />
used in Belgium;<br />
• Four other RCTs 79 80 84 87 had treatment arms that compared the same<br />
intervention; making the evidence for treatment difference not possible.<br />
o Blaise <strong>et</strong> al. (2010) 79 and Hamel-Desnos <strong>et</strong> al. (2008) 87 compared 1% vs 3%<br />
polidocanol foam use in sclerotherapy;<br />
o Doganci <strong>et</strong> al. 84 compared the 980 nm laser and bar-tip fibre with 1470<br />
nm laser and radial fibre (EVLT trial);<br />
o Carradice <strong>et</strong> al. (2009) 80 compared EVLT and EVLT combined with<br />
phlebectomy.<br />
Finally, 15 RCTs were included. The figure below shows the flow of studies in the<br />
review.