Tchartchian 2014.
Study characteristics | ||
Methods | Unit of randomisation: women Method of randomisation: computer‐generated allocation schedule randomising 2:1 externally prepared and stored in envelopes Time of randomisation: not clearly stated but apparently intraoperatively Blinding: women blinded; surgeons analysing recordings blinded. |
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Participants | Women, aged 18 and older, with child‐bearing potential, undergoing laparoscopic myomectomy due to at least one myoma Exclusion criteria: pregnancy, lactation, previous open or closed myomectomy for myomas, active endometriosis, infection, inflammatory of bowel disease, pelvic inflammatory disease, frozen pelvis, hydrosalpinges N = 15 9 randomised to intervention and 6 to control Dropouts: 2 women (one from each group) withdrew consent prior to second‐look laparoscopy Age: mean age 35.8 in intervention group, and 44.3 in control group Baseline characteristics: the control group was significantly older (P = 0.002), had significantly higher gravidity (P = 0.021), and significantly larger number of previous vaginal deliveries (P = 0.038) than the control group. Indication for surgery: myomectomy for removal of at least one myoma Pre‐existing adhesions: 66.7% of the intervention group and 50.0% of the control group had pre‐existing adhesions (P = 0.662) Aetiology of pre‐existing adhesions: not clearly stated Microsurgery: surgery was based on the basic principles of microsurgery Additional surgical procedures: not clearly stated Location: Oldenburg, Germany Timing: November 2008 to May 2009 |
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Interventions | Polyethylene glycol ester amine versus no treatment Other adjuvants used: none stated Second‐look laparoscopy:
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Outcomes | Adhesions at second‐look laparoscopy:
Adverse events |
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Notes | Funding provided by Covidien Video recording performed both at initial surgery and second look laparoscopy Power calculation not performed Clinicaltrials.gov register number: NCT00891657 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Subjects were randomly assigned in a 2:1 ratio to the SprayShield Adhesion Barrier group or the control group according to a computer‐generated allocation schedule." |
Allocation concealment (selection bias) | Low risk | Quote: "Patient blinding was performed intraoperatively through a third person with externally prepared randomisation using envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | women blinded, operating surgeons not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "To blind the reviewer to subject and treatment, all videos were assigned a unique, blind code." "The videos were edited to remove the phase of the SprayShield Adhesion barrier application from treated subjects." "The videos were sent to an independent gynaecological surgeon to obtain standardised, unbiased evaluation of adhesion formation." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 2 out of 15 women lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All outcomes stated in trial registry reported ‐ NCT00891657 |
Other bias | High risk | Multiple statistically significant differences between the two groups at baseline Quote: "Due to the low number of patients' efficacy, data are not final regarding the performance of SprayShield Adhesion Barrier" |