Methods | RCT | |
Participants | 200 women with CIN undergoing knife cone biopsy | |
Interventions | Lateral haemostatic sutures and interrupted sutures if indicated Vaginal pack with Monsels solution |
|
Outcomes | Duration of surgical procedure Operative blood loss Primary haemorrhage Secondary haemorrhage |
|
Notes | ||
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Details about the sequence generation was not given, “Patients were randomly allocated to one or the other haemostatic method by opening one of a batch of sealed envelopes containing the appropriate instruction” |
Allocation concealment? | Yes | “We performed the method allocation after the cone excision to ensure that previous knowledge of the haemostatic method could not influence the operator as to the size or shape of the cone” |
Blinding? All outcomes |
Unclear | Not reported |
Incomplete outcome data addressed? All outcomes |
Yes | For all outcomes: % analysed: 200/205 (98%) 5 women did not wish to participate |
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 |