Methods | RCT | |
Participants | Women who fulfilled criteria for cervical treatment for CIN and had not been treated previously. This included a cytological or colposcopic suspicion of CIN I or worse and unsatisfactory colposcopic examination in the presence of moderate or severe dyskaryosis or persistent mild dyskaryosis. Women with adenocarcinoma in situ were not included in the study Mean age in the trial was 32.6 years (SD=9.4 years) There were 149 (37.25%) women with CIN 1, 124 (31%) with CIN 2, 66 (16.5%) with CIN3, in 33 (8.25%) women there was no pretreatment histology and was another category in 28 (7%) women |
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Interventions | LLETZ: performed using a 1.5, 1.8 or 2.2 cm tungsten diathermy loop (Rocket, Watford, UK) according to the surgeon’s preference for a specific lesion. During a LLETZ procedure, surgeons used diathermy settings according to their usual practice Needle excision: performed with a 2 cm long tungsten wire (Rocket) using a pure coagulation setting of 35W. The intention with both techniques was to remove the specimen in one piece if possible |
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Outcomes |
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Notes | There was no difference in the cumulative risk of developing a recurrent or residual high grade intraepithelial lesion between the two groups at follow up (log-rank test= 0.13, P= 0.72) but the study would have needed over 1200 subjects to assess recurrence rates reliably Duration of procedure (secs): median= 90 [range: 60-120] for LLETZ procedure and median= 210 (range: 180-300) for NETZ |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “Women were randomised by telephone to the trial office where a computer generated randomisation list was kept securely. Block randomisation was used with varying sized groups”. |
Allocation concealment? | Yes | “Women were randomised by telephone to the trial office where a computer generated randomisation list was kept securely” |
Blinding? All outcomes |
Unclear | “Histological analysis was performed by the routine pathological service in each hospital. Histopathologists were unaware of the type of treatment patients received”. However, it was unclear whether or not those analysing the data were blinded to the treatment mode |
Incomplete outcome data addressed? All outcomes |
Yes | For cervical stenosis outcome % of women analysed: 339/400 (85%) By treatment arm LLETZ: 167/200 (84%) Needle excision: 172/200 (86%) All other outcomes analysed at least 85% 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 |