Methods | RCT | |
Participants | 375 women with cervical smears suggesting CIN 2 or 3, or 2 smears equivalent to CIN1 Women with adequate colposcopy included with entire lesion visible, not pregnant Women with vaginitis, lesion extending to vagina, evidence of invasion excluded | |
Interventions | Primary LLETZ Colposcopic directed biopsy and endocervical curettage, Only if positive laser ablation of transformation zone |
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Outcomes | Histological status of LLETZ or colposcopic specimens Operators impression of significant peri-operative bleeding Women’s subjective opinion of peri-operative pain Women’s subjective opinion of post-operative severe discomfort, heavy discharge, severe bleeding Residual disease (cytology) at 3 and 6 months |
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Notes | 195 randomised to LLETZ, 180 to Laser All women had paracervical 1% lidocaine with 1:100,000 ephedrine LLETZ group: 6 treated by laser ablation due to technical problems, 4 failed to attend for treatment Laser group: 66 women did not require treatment, 114 required treatment 4 women were treated by LLETZ, 2 by cryosurgery due to technical problems |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Computer generation was used to assign women to either LLETZ or laser, “they (patients) were assigned a treatment strategy by computer-randomised forms” |
Allocation concealment? | Yes | “Computer-randomised forms contained in sealed opaque envelopes”, were used as a method of concealment |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
No | % analysed: 190/375 (51%) and 107/375 (29%) for residual disease at 3 and 6 months respectively, “of the 190 who were compliant with follow up 3 months after treatment … 107 returned for a second evaluation at 6 months” All other outcomes assessed more than 51% of women. |
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 |