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 |
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Outcomes |
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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 |