Methods | RCT | |
Participants | 80 women recruited with CIN 3 Women with a history of previous cervical surgery, peri- or post-menopausal or whose lesion extends to vagina |
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Interventions | Laser conisation LLETZ |
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Outcomes | Subjective scoring of pain by attendant nurse Subjective scoring of pain by women by linear analogue scale Peri-operative bleeding (none, spotting, requiring coagulation) Operative time |
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Notes | All women had intracervical 4mls 2% lignocaine with 0.3 IU /mls octapressin prior to treatment (1 spoiled data sheet) 43 women randomised to laser conisation 36 women randomised to LLETZ |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “Women were then randomised to … laser or the loop diathermy” “Computer-generated simple randomisation”,was used to assign women to either laser or LLETZ |
Allocation concealment? | Yes | “randomisation code was held in sealed opaque envelopes which also contained the data sheets” |
Blinding? All outcomes |
Unclear | “It was not possible to conceal the form of intervention used from the surgeon or attendant but the patient was not told whether she was having laser or loop treatment”. However, it was not reported whether or not the outcome assessor was blinded |
Incomplete outcome data addressed? All outcomes |
Yes | % of women analysed: 79/80 (99%) |
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 |