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

Cheong 2017.

Study characteristics
Methods Unit of randomisation: women
Method of randomisation: computer‐generated random numbers in concealed envelopes
Time of randomisation: randomised intraoperatively
Blinding: women blinded. Assessors at follow‐up blinded.
Participants Women aged between 18 and 38 years, undergoing gynaecological laparoscopy with possible peri‐ovarian adhesions
Exclusion criteria: presence of, or history of malignancy, women on medications affecting ovulation, women with known conditions resulting in anovulation
N = 30
15 randomised to intervention and 15 to control
Dropouts: None stated. Flow diagram states 17 women randomised to intervention group, however, all other text states 15.
Age: mean age 32.7 in intervention group, 31.5 in control
Baseline characteristics: states no significant differences
Indication for surgery: not clearly stated. States undergoing laparoscopy for gynaecological pathology.
Pre‐existing adhesions: all women had peri‐ovarian adhesions and underwent adhesiolysis.
Aetiology of pre‐existing adhesions: not stated
Microsurgery: principles of microsurgery were followed
Additional surgical procedures: not clearly stated, but all women underwent surgery for some form of gynaecological pathology
Location: Southampton, UK
Timing: December 2011 to January 2014
Interventions Cross‐linked hyaluronic acid versus no treatment
Other adjuvants used: none stated
Second‐look laparoscopy not performed
Outcomes Pregnancy outcomes:
Ovarian function
Clinical pregnancy rate at 2 years
Notes Funding provided by Nordic Pharma
No power calculation performed
ISRCTN Number: ISRCTN1833588
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated random numbers. The randomisation code was broken at the end of follow‐up period
Allocation concealment (selection bias) Low risk Consent was obtained prior to baseline assessment. Concealed, opaque, unlabelled envelopes were opened only after it had been determined that the woman met the intraoperative criteria
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk women were blinded to the allocation treatment, but the primary surgeon was not blinded; women who wished to know their treatment group were informed at the end of follow‐up period.
Blinding of outcome assessment (detection bias)
All outcomes Low risk The assessor who administered the questionnaires and recruited the women was the research nurse who did not have prior knowledge of what type of surgery the women underwent. The assessor during follow‐up was blinded to treatment.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 2 women randomised to Hyalobarrier were lost to follow‐up and were not accounted for; low initial sample number (43 screened, 32 randomised)
Selective reporting (reporting bias) Low risk All outcomes stated in clinical trial registry are reported per doi: org/10.1186/ISRCTN18335881
Other bias Unclear risk 80% of women in intervention group had mild adhesions initially, versus 46.7% in control group. Paper states no difference in severity between the two groups, however, no statistical analysis was provided.