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. 2020 Mar 22;2020(3):CD000475. doi: 10.1002/14651858.CD000475.pub4

Takeuchi 2005.

Methods Unit of randomisation: participant
 Method of randomisation: computer‐generated
 Time of randomisation: before surgery
 Blinding: absent
Participants Women (N = 146) undergoing laparoscopic myomectomy; 69 in control group, 68 in fibrin gel group, and 68 in fibrin sheet group
 2 became pregnant, 23 had other surgical procedures, 29 women with fibroid < 5 cm were excluded
 Pre‐existing adhesions: nil
 Mean age: no statistically significant difference
 Timing: 2001 to 2002
 Country: multi‐centric
Interventions Fibrin sheet placed on site of myomectomy wound vs uncovered wound
Other adjuvants used: none
Second‐look laparoscopy
  1. Timing: between 13 and 19 weeks after initial surgery

  2. Surgeon unaware: yes

  3. Adhesiolysis: in participants who had adhesions present at second‐look laparoscopy

Outcomes Adhesions at second‐look laparoscopy at 13 to 16 weeks
  1. Incidence (adhesion formation per participant)

  2. Adverse effects

Notes Documentation of adhesions unclear
 No power calculations
 Support funding: unclear
 Multi‐centre trial
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation performed using computer‐generated lists
Allocation concealment (selection bias) Unclear risk Not clearly stated
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not clearly stated whether participants or initial surgeons were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not clearly stated whether surgeon performing or assessing second‐look laparoscopy was blinded
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk High attrition rate, with only 91 of 146 patients undergoing SLL
Quote: "SLL was planned for 146 patients," "23 patients who underwent other surgical procedures (prior to SLL) were excluded," "29 patients in whom the maximum myoma diameter was < 5 cm were excluded," "[for] 2 women SLL was cancelled because they became pregnant," "consequently, 91 patients who underwent (surgery) alone were evaluated"
Selective reporting (reporting bias) Unclear risk Data reported as incidences and percentages. P values reported only for significant outcomes. No subsets of data. No pre‐published protocol identified. mAFS score done, but no standard deviations reported (review authors unable to extract standard deviations from data published in study paper because of the way they had been presented)
Other bias Low risk No other bias identified