Methods | Multicentre RCT | |
Participants | Country: German Democratic Republic 120 women with squamous cell carcinomas of the cervix uteri stage pT1bN0M0 previously treated by radical hysterectomy The mean age at study entry was 40.6 years (range: 23 to 60 years) All women presented with FIGO stage I. Tumour cell type was squamous in all 120 (100%) women Tumour grade: 1: 36 (30%), 2: 60 (50%), 3: 24 (20%) |
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Interventions | Women were randomised into 2 groups:
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Outcomes |
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Notes | Mean length of follow-up was 44 months (range 24 to 72 months) | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | For all outcomes: % analysed: 120/120 (100%) “All patients (n = 120) entered into the study were evaluable for survival rate, date and anatomical location of recurrences, results of autopsy and morbidity of therapy” |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |