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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001318. doi: 10.1002/14651858.CD001318.pub2
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
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
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
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