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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001318. doi: 10.1002/14651858.CD001318.pub2
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
Interventions Laser conisation
LLETZ
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
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
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