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. 2020 Mar 22;2020(3):CD000475. doi: 10.1002/14651858.CD000475.pub4

Saravelos 1996.

Methods Unit of randomisation: ovaries
 Method of randomisation: computer‐generated in opaque envelopes
 Timing of randomisation: unclear
 Blinding: double
Participants Women (N = 21) undergoing treatment for polycystic ovarian syndrome by ovarian electrocautery
 7 dropouts: 4 were pregnant, 2 withdrew, 1 had such dense adhesions at laparoscopy of both ovaries that no assessment could be made
Pre‐existing adhesions: nil
 Mean age, years: 28
 No other cause for infertility found
 Timing: 1994 to 1995
Country: UK (1 centre)
Interventions Oxidised regenerated cellulose vs no treatment
Outcomes Adhesion formation
  1. Incidence

  2. Extent

  3. Severity


Further adhesiolysis
 Timing of second‐look laparoscopy: 2 to 11 weeks
 Pregnancy: outcomes given but ovaries randomly assigned, not participants
Notes Supported by Johnson & Johnson
 Video taken
 Power calculations: nil
 No intention‐to‐treat analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No clear statement provided regarding method of randomisation
Allocation concealment (selection bias) Unclear risk Sealed envelopes used for allocation concealment but unclear when sealed or opened. Quote: "a sealed envelope disclosed the assignment of which side was to be treated with Interceed"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Unit of randomisation was right or left ovary, so every woman also acted as her own control
Not clearly stated whether surgeon was blinded, or when treatment allocation was revealed
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Second‐look laparoscopy was video‐recorded and assessed by independent blinded assessors
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 1 participant excluded, as underwent ovarian drilling; 4 withdrew because of pregnancy; 2 withdrew because of personal choice (n = 21)
Selective reporting (reporting bias) Unclear risk Data reported as incidences and percentages. No data conversion. No P values reported
Other bias Low risk No other bias identified