Mettler 2004.
Study characteristics | ||
Methods | Truly randomised trial (computer‐generated).
Blinding: yes
Time of randomisation: not stated Multi‐centre—Germany and France |
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Participants | 64 women with a mean age of 34.9 years undergoing laparoscopy or laparotomy for treatment of fibroids Exclusion criteria:
Number of women randomly assigned: 64 Number of women undergoing second‐look laparoscopy: 62.5% return rate for second look |
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Interventions | Polyethylene glycol versus no treatment | |
Outcomes | Analysed in review
Presence or absence of adhesions at second‐look laparoscopy
Other outcomes
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Notes | Adhesion scoring system used Mean adhesion tenacity score | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated randomization schema" |
Allocation concealment (selection bias) | Low risk | Quote: "Until the completion of the surgical resection procedure, at which time a preprinted, sealed envelope was opened" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention is made of an independent, blinded reviewer at SLL |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Data presented in full for all outcomes specified, however, no study protocol or trial registry identified for comparison |
Other bias | Low risk | Funded by Confluent Surgical |