Skip to main content
. 2020 Jul 17;2020(7):CD001298. doi: 10.1002/14651858.CD001298.pub5

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:
  1. History of infertility or recurrent miscarriages

  2. Lack of pedunculation of the main myoma

  3. Presence of not more than 4 myomas

  4. Absence of submucosal fibroids as screened by hysteroscopy

  5. No calcification of the main myoma

  6. Absence of abnormal cervical smear

  7. Negative urine pregnancy test


Exclusion criteria:
  1. women who did not fulfil the inclusion 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