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. 2014 Jun 27;2014(6):CD010409. doi: 10.1002/14651858.CD010409.pub2

Rob 2007.

Study characteristics
Patient sampling Prospective study; consecutive sampling (unpublished information). 9 women with 'bulky nodes' were excluded (unpublished information)
Patient characteristics and setting 59 women with vulval SCC stage IB/II; 86 groins
Excluded lesions > 4 cm and women with clinically suspicious nodes
Age range: 26 to 95 years
Setting: a university hospital in the Czech Republic; recruited from December 2001 to December 2005
Index tests Blue dye only (16 women) and combined technique (blue dye and Tc‐99m; 43 women)
Frozen section and ultrastaging with H&E and IHC were performed for SNs. Standard methods were used for non‐SNs
Target condition and reference standard(s) TC: groin lymph node involvement
RS: complete IFL
Flow and timing Tracer agents were injected intradermally around tumour at 3 sites. Tc‐99m was injected 3 to 4 hours pre‐operatively in a volume of 0.2 to 0.4 ml. Blue dye (1 to 2 ml) was injected 2 to 3 minutes pre‐operatively. SN location was marked on skin.
Tc‐99m was detected intra‐operatively by a gamma probe. First SN was identified and nodes exhibiting at least 10% of activity at the area of application were also removed. Blue stained lymphatics were identified visually
SND and IFL were performed during the same operation
Comparative  
Notes Investigators reported the blue dye and combined technique accuracy results separately. Additional methodological information and groin data (for the combined technique) were supplied to us by the investigators via email (4 July 2013).
16% of identified SNs were deep femoral groin nodes
Frozen section was 98% accurate in this study and influenced the extent of the IFL
The optimum timing of pre‐operative LSG was 45 minutes after the Tc‐99m injection
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
    Low Low
DOMAIN 2: Index Test Test group
Had the test operator performed 10 or more procedures? Unclear    
    Unclear Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    Unclear Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
Were other imaging tests performed prior to the index test to rule out groin lymph node metastases? Yes    
    Unclear