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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 400 women with histologically confirmed high grade squamous intraepithelial lesions Mean age in the trial was 32.4 years (SD=6.2 years)
Interventions LEEP: For each loop procedure the cervix was injected with 4 ml of 1% lignocaine with 1:100 000 epinephrine 1-2 mm beneath the cervical surface epithelium at 12, 3, 6 and 9 o’clock positions. We used a large speculum adapted for smoke evacuation and a 2×2 cm electrode was used for large lesions and 1×1 cm electrode for the smaller lesions. The electrosurgical generator (Surgitron Ellman International, New York, USA) was operated using the cutting mode recommended by the manufacturer
Cryotherapy: The PCG-R Portable Cryosurgical Gun (Spembly Medical Ltd, UK) was used for cryotherapy. A large speculum was placed into the vagina and after the lesion was identified by colposcopy an appropriate-sized
probe to cover lesion and transformation zone was selected. A lubricant (KY jelly, Johnson and Johnson, South Africa) was applied to the probe before treatment of the cervix. The cervix was treated for 2 minutes, thawed and treated again for 2 minutes to allow an ice ball to form across the lesion and transformation zone
Outcomes
  • Residual disease at 6 and 12 months follow up

  • Pain

  • Haemorrhage

  • Secondary haemorrhage

  • Discharge (watery/offensive)

Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes “Treatment allocation was performed by a research nurse in a separate setting in accordance with computer-generated randomisation sequences stratified per treatment”
Allocation concealment? Yes “Treatment allocation was performed … using consecutively numbered opaque sealed envelopes”
Blinding?
All outcomes
Unclear “The colposcopist was blinded with regard to treatment allocation”. However, it was unclear as to whether the outcome assessor was blinded
Incomplete outcome data addressed?
All outcomes
Yes For residual disease at 6 months:
% of women analysed: 327/400 (82%)
By treatment arm:
LEEP: 159/200 (80%)
Cryotherapy: 168/200 (84%)
All other outcomes assessed more than 327 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