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