Boran 2003.
| Study characteristics | |||
| Patient sampling | Prospective pilot study; consecutive enrolment | ||
| Patient characteristics and setting | 10 women with vulval cancer stage T1/T2 (17 groins). It is unclear whether any women with T1a (stage IA) lesions were included 3 had lateralised tumours and 7 had midline tumours Excluded women with clinically suspicious lymph nodes Median age: NR Setting: a tertiary institution in Turkey between April 2000 and April 2002 |
||
| Index tests | Tc‐99m only Histological methods: IHC stain performed on SNs if H&E was negative |
||
| Target condition and reference standard(s) | TC: groin lymph node involvement RS: complete IFL |
||
| Flow and timing | Approximately 45 to 60 minutes pre‐operatively, 0.4 to 0.6 ml Tc‐99m was injected circumferentially intradermally. A hand‐held gamma counter was used to identify 'hot' nodes. After the first SN was removed, the groin was re‐examined and dissection was continued if more 'hot' nodes were identified (defined as > 10% of the 'hottest' SN) SND and RS were performed during the same operation Withdrawals, if any, were not described |
||
| Comparative | |||
| Notes | A brief report (letter to the editor). Investigators state that being in the "learning curve" of performing the procedure may have affected the results ICH staining did not reveal additional nodal involvement |
||
| 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? | Unclear | ||
| Unclear | Unclear | ||
| DOMAIN 2: Index Test Test group | |||
| Had the test operator performed 10 or more procedures? | No | ||
| High | 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 | ||
| Unclear | |||