Methods | RCT | |
Participants | 204 women with entire squamo-columnar junction visible CIN 1 on 2 biopsies 3-6 months apart, CIN 2 or 3 not extending 3 mm into crypts No extension onto vagina or lesion or 12.5 mm into canal |
|
Interventions | Cryotherapy Laser ablation |
|
Outcomes | Operators impression of significant peri-operative bleeding >25cc Women’s subjective opinion of peri-operative pain (mild, moderate severe, Severe being that the woman would not consider the treatment again) Women’s subjective opinion of post-operative discomfort, heavy discharge, bleeding (none, mild, moderate, severe) Post operative cervical stenosis Satisfactory follow-up colposcopy at 3 months Berget 1991 reports longer follow up for residual disease outcome: residual disease (histological) at 3, 9, 15, 21, 33, 45, 80 months |
|
Notes | 103 randomised to laser, 101 randomised to cryotherapy Laser performed ablated 2 mm lateral to transformation zone to a depth of 5-7mm Cryo coagulation (double freeze thaw freeze technique) or more if the ice ball did not exceed the probe (25mm) by 4 mm. Local analgesia was not routinely administered 6 laser and 2 cryotherapy women refused to be followed up Women were offered repeat treatment with the same method of treatment as part of protocol. 3 laser and 6 cryotherapy women refused repeat treatment |
|
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not reported, “patients fulfilling the criteria were randomized to either laser or cryo treatment” |
Allocation concealment? | Unclear | Not reported |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
Yes | For residual disease: % analysed: 187/204 (92%) Laser; 94/103 (91%) Cryotherapy; 93/101 (92%) All other outcomes had less loss to follow up |
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 |