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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 All women over 20 years of age who required a LLETZ for suspected CIN on colposcopy Mean age in the trial was 34.4 years (SD=9.2 years)
Interventions Pure cut: the standard Valleylab force 2 electrosurgical generator (Valleylab, CO) was set to 90W
Blend 1: both cut and coagulation were set to 60W. The diathermy setting blend 1 is a combination of 50% cutting waveform and 50% coagulating waveform
Prior to the procedure, the extent of the lesion was determined with 3% acetic acid and the cervix was injected with 4-6 ml of 3% prilocaine hydrochloride with felypressin. The size of the disposable loop was selected by the operator and performed in the standard way
Outcomes Residual disease (follow-up smear 6 months after LLETZ procedure)
Grading and depth of thermal artefact
Notes Residual disease was assessed at 6 months follow up based on a smear result
Mean depth of thermal artefact at the epithelial margin was 0.292 mm in the blend group and 0.270 mm in the cut group (P=0.237). It was not possible to obtain a SD so this could not be displayed on a forest plot
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear ”Randomization was performed using sequential sealed envelopes. No blocking or stratification was carried out“
Allocation concealment? Unclear ”Randomization was performed using sequential sealed envelopes“. It was unclear whether these were opaque sealed envelopes
Blinding?
All outcomes
Unclear Not reported
Incomplete outcome data addressed?
All outcomes
Yes ”Three eligible women declined to take part in the trial and three were not randomized for unknown reasons. The remaining 49 women were randomized to either the cut or the blend setting for the LLETZ procedure
Of the 55 eligible patients
% of women analysed: 49/55 (89%)
Of the 49 patients who were randomised
% of women analysed: 49/49 (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