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

Klar 2011.

Study characteristics
Patient sampling Prospective; consecutive enrolment; 4 exclusions
Patient characteristics and setting 20 women with vulval SCC, FIGO stage IB; 29 groins; 3 unilateral and 13 bilateral LNDs
Excluded women with no obvious nodes or women with other histology
Median age: 66 years (36 to 88)
Setting: tertiary institution in Germany; September 2007 to March 2010
Index tests Tc‐99m only
Histological methods: ultrastaging with IHC staining was performed for SNs if standard section with H&E stain was negative; standard sections with H&E stains were performed for other nodes (RS)
Target condition and reference standard(s) TC: groin lymph node involvement
RS: complete IFL
Flow and timing After GA, 0.3 ml of 10 MBq (4 x 2.5) Tc‐99m was injected intradermally at 4 sites around the tumour. Detected immediately thereafter by gamma probe. Dissection was continued if more 'hot' nodes were identified (> 10% of the 'hottest' SN).
SND and RS were performed during the same operation
 4 withdrawals described including 1 woman with vaginal melanoma and 3 women with obvious groin node metastases
Comparative  
Notes This study evaluates the feasibility of a more convenient and less invasive way of administering the index test (Tc‐99m only).
Midline defined as within 1 cm of the midline
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? Yes    
    Low 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? Unclear    
    Low