Methods | RCT | |
Participants | 300 women with CIN 1,2,3 Women with adequate colposcopy, no evidence of invasion |
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Interventions | Laser conisation LLETZ |
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Outcomes | Duration of treatment Patient subjective assessment of pain (none/minimal, moderate, severe) Peri-operative blood loss (difference in weight of blood stained/dry swabs) Secondary haemorrhage Presence of thermal artifact not permitting evaluation of resection margins Dysmenorrhoea Residual disease at 3-12 months |
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Notes | 150 women randomised to laser conisation, 150 to loop excision Intra-cervical 6mls Citanest (0.5% prilocaine with octapressin) used pre-operatively |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Not reported, merely states that, “women were randomized to receive treatment either by loop diathermy excision or laser excisional conization” |
Allocation concealment? | Yes | “The women were randomized to receive treatment either by loop diathermy excision or laser excisional conization by drawing from a box of sealed, opaque, mixed envelopes of the same color and size, each of which contained the name of one of the procedures” |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
Yes | % of women analysed: 295/300 (98%) or secondary haemorrhage, dysmenorrhoea and residual disease: “All patients except two in group 1 and three in group 2 attended at least one follow-up clinic. Attempts to contact these patients by telephone, letter, or through their general practitioners failed. ” 100% of women were assessed for all other outcomes as they could be measured during or immediately after surgery |
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 |