Methods | RCT | |
Participants | 240 women with CIN 1,2,3. All procedures were done as in-patients Mean age in the trial was 32.5 years (SD=8 years). There were 9 (3.75%) women with CIN 1, 71 (30%) with CIN 2, 152 (63%) with CIN 3, 6 (2.5%) women had stage Ia cervical cancer and 2 (0.75%) women had negative histology |
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Interventions | Knife conisation: wound was sutured with two semicircular sutures (Vicryl, Ethicon, Edinburgh, UK), thus reconstructing the cervix LLETZ: performed using an Elektrotom 400 unit (Brechtold, Tuttlingen, Germany) with loop devices ranging in size from 10 to 20mm. The procedure was performed using a blended current with the cut frequency set at 40 W and the coagulation frequency set between 20 and 40 W |
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Outcomes | Completeness of excision (endo/ectocervial disease involvement) Adequate colposcopy rates after treatment Primary haemorrhage |
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Notes | 120 randomised to Knife cone 120 randomised to LLETZ |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not reported |
Allocation concealment? | Unclear | Not reported |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
Yes | % of women analysed: 120/120 (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 |