Pellicano 2003.
| Study characteristics | ||
| Methods | Truly randomised trial (computer‐generated central randomisation)
Double‐blinded (known by correspondence with study author)
Power calculation: no
Intention‐to‐treat analysis: yes Single‐centre—Italy |
|
| Participants | Infertile women undergoing laparoscopic myomectomy 36 women randomly assigned and analysed Inclusion criteria:
Exclusion criteria:
Mean age: 26.8 years Both groups demographically similar at the start of the study Number of women randomly assigned: 36 Number of women analysed after second‐look laparoscopy: 36 |
|
| Interventions | Auto‐cross‐linked hyaluronic acid gel versus no treatment Time of application: at the end of the procedure Second‐look laparoscopy: 60 to 90 days after the primary procedure | |
| Outcomes | Analysed in review Presence of adhesions at second‐look laparoscopy Other outcomes Incidence of adhesions with regards to the site of the primary myoma Pregnancy rates: no |
|
| Notes | Scoring system not used, only rate of the presence or absence of adhesions | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random list |
| Allocation concealment (selection bias) | Unclear risk | No reference to allocation concealment in article |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No reference to blinding in article, although study author contacted and confirmed both women and initial surgeons were blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficent information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 36 women enrolled; all evaluated by second‐look laparoscopy |
| Selective reporting (reporting bias) | Unclear risk | Data presented in full for all outcomes specified, however, no study protocol or trial registry identified for comparison |
| Other bias | Low risk | |