Methods | RCT | |
Participants | 200 women with CIN 1,2,3 Adequate colposcopy, no evidence of invasion |
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Interventions | Laser ablation Cryotherapy |
|
Outcomes | Severe cramps Vasomotor symptoms Residual disease at 6 months. |
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Notes | 100 women randomised to laser ablation, 100 randomised to cryotherapy Cryo coagulation (single freeze thaw technique) using a probe (18mm) with ice ball extending 5 mm beyond abnormal epithelium Laser ablation of all transformation zone No patient was lost to follow up |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | “The study was designed … in as objective a way as possible by alternating cases randomly insofar as possible on the bases of histologic grade and lesion size”. This study seems to deploy the method of minimisation and aims to minimise the imbalance between the number of patients in each treatment group over two important prognostic factors |
Allocation concealment? | Unclear | Not reported |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
Yes | % of women analysed: 200/200 (100%) |
Free of selective reporting? | Unclear | Insufficient information to permit judgement |
Free of other bias? | Unclear | Insufficient information to assess whether an important risk of bias exists |