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

Goni 2011.

Study characteristics
Patient sampling Prospective study
Patient characteristics and setting 24 women with vulval cancer (22 SCC; 2 other), clinical stage I and II. Number of groins evaluated is unclear
Excluded women with clinically suspicious groin nodes
Mean age: 71 (43 to 85)
Setting: a tertiary institution in Spain; enrolment from 2001 to 2011
Index tests Tc‐99m only
Standard histological methods were used for SN assessment and IHC staining was performed if H&E stain was negative
Target condition and reference standard(s) TC: groin lymph node involvement
RS: complete IFL
Flow and timing Procedure: 24 hours pre‐operatively, Tc‐99m was injected and LSG performed (details not reported). Radioactivity was detected intra‐operatively by hand‐held gamma probe. SND and RS were performed during the same operation
 Withdrawals were not described
 Mean follow‐up was 23 months
Comparative  
Notes Conference abstract only
The number of women with midline/lateralised tumours and who underwent bilateral or unilateral IFL is not stated
Midline lesions were not defined
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
    Unclear 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? Unclear    
Were other imaging tests performed prior to the index test to rule out groin lymph node metastases? Unclear    
    Unclear