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Needle versus loop diathermy excision of the transformation zone for the treatment of cervical intraepithelial neoplasia : a randomised controlled trial . OBJECTIVE To determine whether lower rates or incomplete resection of cervical intraepithelial neoplasia ( CIN ) may be achieved by needle excision of the transformation zone ( NETZ ) than with loop excision ( LLETZ ) . DESIGN A prospective randomised controlled trial . SETTING A gynaecological oncology centre and a teaching hospital in West London . POPULATION Four hundred and four women due to receive treatment for suspected CIN . METHODS Women were randomised to receive either LLETZ or NETZ . MAIN OUTCOME MEASURES The study was designed to demostrate a difference in the proportion of women with clear histological margins of 82 % for LLETZ compared to 94 % for NETZ with 90 % power at a 5 % significance level , allowing for absence of CIN in the treatment specimen in 15 % . RESULTS Four randomised women were excluded from the analysis , as they were ineligible for the study . Three hundred and forty-seven ( 87 % ) had CIN in the treatment specimen and could be included in the analysis of excision margins . More women in the NETZ arm had clear histological margins ( 84.8 % vs 75 % , ( P= 0.03 ) . The median volume of specimens in the NETZ arm was 739 mm ( 3 ) larger ( P= 0.33 ) and they were less likely to be removed in multiple pieces ( 2.5 % vs 29.5 % , RR 0.09 , 95 % CI 0.04 to 0.20 ) . Needle excision took longer to perform ( median treatment time 210 vs 90 seconds , P < 0.0001 ) and surgeons more often reported the procedure as 'difficult ' ( 9.5 % vs 3.0 % , RR = 3.17 % , 95 % CI 1.33 to 7.58 ) . No difference in peri-operative or post-operative complication rates could be demonstrated between the two groups . CONCLUSION NETZ is more likely to produce a specimen in one piece and with clear margins compared to LLETZ .
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Intervention_Surgical
Needle versus loop diathermy excision
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Intervention_Surgical
needle excision of the transformation zone ( NETZ )
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Intervention_Surgical
loop excision ( LLETZ )
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Intervention_Surgical
LLETZ
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Intervention_Surgical
NETZ
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Intervention_Surgical
LLETZ
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Intervention_Surgical
NETZ
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Intervention_Surgical
NETZ
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Intervention_Surgical
LLETZ
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Outcome_Physical
proportion of women with clear histological margins
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Outcome_Physical
clear histological margins
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Outcome_Physical
median volume of specimens
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Outcome_Other
longer to perform ( median treatment time
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Outcome_Other
reported the procedure as 'difficult '
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Participant_Condition
cervical intraepithelial neoplasia :
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Participant_Condition
cervical intraepithelial neoplasia ( CIN )