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. 2020 Jul 17;2020(7):CD001298. doi: 10.1002/14651858.CD001298.pub5

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
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
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
Notes Funded by Genzyme
Clinicaltrials.gov register number: NCT00624390
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