Methods | RCT | |
Participants | 180 women recruited with all grades of CIN with the following inclusion criteria: 1) unsatisfactory colposcopy with positive biopsy 2) endocervical curettage with positive biopsy 3) possible microinvasion on biopsy |
|
Interventions | LLETZ Knife conisation |
|
Outcomes | Adequate colposcopy Cervical stenosis Incomplete resection margins Residual disease at 3 months |
|
Notes | 91 women randomised to LLETZ 89 women randomised to knife conisation |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “Randomization to receive treatment by cold-knife conization (n = 89) or conization by the loop electrosurgical excision procedure (n = 91) was accomplished with a computer program using a permuted block design” |
Allocation concealment? | Unclear | Not reported |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
No | % of women analysed: 140/180 (78%) were assessed for cervical stenosis. All other outcomes assessed more than 140 patients |
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 |