Fossum 2011.
Study characteristics | ||
Methods | Truly randomised trial: not stated
Time of randomisation: at conclusion of initial surgery before closure
Blinding: assessor blinded Power calculation: not used ITT: no Location: multi‐centre trial in USA Timing and duration: not stated |
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Participants | Inclusion criteria: non‐pregnant women between 18 and 49 years of age scheduled to undergo laparoscopic myomectomy for resection of at least 1 uterine fibroid (N = 41) Exclusion criteria: intraoperatively if infection or abscess identified, if entry into endometrial cavity or bowel lumen noted, if adhesiolysis involving bowel wall performed, or if concurrent, non‐gynaecological procedure was performed Number undergoing second‐look laparoscopy: 38 Timing second‐look laparoscopy: 4 to 12 weeks after initial surgery |
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Interventions | Hyaluronic acid and carboxymethylcellulose versus no treatment | |
Outcomes | Presence or absence of adhesions, extent and severity at 14 intra‐abdominal and pelvic sites at initial surgery and second‐look laparoscopy (mAFS score) Adverse effects |
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Notes | Funded by Genzyme Clinicaltrials.gov register number: NCT00624390 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No comment on randomisation method |
Allocation concealment (selection bias) | Unclear risk | No comment on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to provide judgement |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Surgeries videotaped and reviewed by blinded investigator |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No issues identified |
Selective reporting (reporting bias) | Low risk | All outcomes specified in trial registry reported ‐ NCT00624390 |
Other bias | High risk | Data were only displayed in graphs, with no indication of SD, SE, CI or P value |