Methods | RCT | |
Participants | 100 women with CIN 1,2,3 Women with adequate colposcopy , no evidence of invasion, lesion no more than 5mm into canal |
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Interventions | Laser conisation Laser ablation |
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Outcomes | Duration of treatment Significant peri-operative bleeding Women’s subjective opinion of peri-operative pain (mild, moderate, severe) Secondary haemorrhage (seen in out-patients) Secondary haemorrhage (required admission) Adequate colposcopy Cervical stenosis Dysmennorrhoea Residual disease at 6, 12, 24 months |
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Notes | 50 women randomised to laser conisation, 50 women randomised to laser ablation Haemostasis achieved by pressure with a cotton swab or Monsel solution Laser Excision 2mm margin to lesion and to a depth of 2-3mm Laser ablation to a depth of 10mm Intra-cervical 3% prilocaine with octapressin used pre-operatively |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not reported |
Allocation concealment? | Yes | “Patients were randomised to treatment … by drawing sealed envelopes” |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
Yes | % of women analysed: 93/100 (93%) for residual disease By treatment arm Laser conisation: 45/50 (90%) Laser ablation: 48/50 (96%) All other outcomes analysed all 100 patients |
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 |