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
|
|
Outcomes | Adhesions at second‐look laparoscopy at 13 to 16 weeks
|
|
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 |