Methods | RCT | |
Participants | 40 women with severe dysplasia/in situ carcinoma of the uterine cervix who underwent cervical conisation Mean age in the trial was 34.8 years (SD=5.7 years) There were 31 (77.5%) women with CIN II and 9 (22.5%) with CIN 3 |
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Interventions |
Interventions: Unipolar energy scalpel (Medizin-Elektronik Elektroton 300, MARTIN, Tuttlingen, Germany) Biopolar electrocautery scissors (Power Star; Ethicon, Inc, Somerville, NJ) Biopolar electrocautery scissors are easy to handle; they have the same shape as surgical scissors, with an isolated nylon handle, and the two blades are separated by a thin ceramic layer, thus producing two active bipolar electrodes |
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Outcomes |
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Notes | Primary haemorrhage was deduced by fact that, haemorrhages was for number of women, therefore it had to be a woman’s first haemorrhage Adequacy of margins of the lesion: bipolar scissors: 11/20, monopolar scalpel: 9/20 Healing of cervix: bipolar scissors: 28.3 days (SD=4.4 days), monoploar scalpel: 35.2 days (SD=6.3 days) Duration of recovery: bipolar scissors: 3.5 days (SD=1.5 days), monoploar scalpel: 6.4 days (SD=3.2 days) There were no infections in either group. |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “Monopolar or bipolar assignment was obtained by means of a table of random digits” |
Allocation concealment? | Yes | “Surgical methods were assigned randomly by drawing a sealed envelope … An independent party filled and sealed the envelopes which were placed in a sealed box” |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
Yes | % analysed: 40/40 (100%) |
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 |