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

Greenblatt 1993.

Methods Unit of randomisation: ovary
 Method of randomisation: not stated
 Time of randomisation: at completion of surgery
 Blinding: surgeon at second‐look laparoscopy unaware of side that was treated
Participants Patients undergoing bilateral ovarian cautery by laparoscopy
 N = 8; 1 exclusion, 7 participants, 14 ovaries
 Indication for surgery: infertility due to clomiphene‐resistant PCOS
 Pre‐existing adhesions: no
 Microsurgery: no
Age, mean, years: 26.6
 Duration of infertility, mean, years: 3.2 (range 1.5 to 5)
 Tubal status: normal HSG and laparoscopy
 Ovulatory status: BBT and serum progesterone
 Semen analysis: done but results not stated
Location: Canada
 Timing and duration: not stated
Interventions Oxidised regenerated cellulose on ovary vs uncovered opposite ovary
Other adjuvants used: none
Second‐look laparoscopy
  1. Timing: 3 to 4 weeks after initial surgery

  2. Surgeon unaware: yes

  3. Adhesiolysis: yes

Outcomes Adhesions at second‐look laparoscopy: at 3 to 4 weeks
  1. Incidence (per ovary)

  2. Adhesion score

  3. Scoring: revised AFS classification (Fertility and Sterility 1988;49:944‐55)


Adverse effects
 Pregnancy outcomes stated but not by intervention, as unit of randomisation was ovaries
Notes Power calculation: nil
 Documentation: video
 Sponsored by MRC Canada (Interceed provided by Johnson & Johnson)
 No intention‐to‐treat analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No clear statement of method of random sequence generation. Quote: "Interceed was applied to one ovary, selected randomly"
Allocation concealment (selection bias) Unclear risk No clear statement of method of allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Unit of randomisation is ovary, so all women served as their own controls
Surgeon was not blinded to intervention. Study authors also do not state whether treatment allocation took place intraoperatively
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessment was performed by an independent blinded surgeon: "three to 4 weeks later, subject returned to the surgical short‐stay unit. They underwent a second laparoscopy performed by a different surgeon, unaware of which side had been wrapped with Interceed"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 1 exclusion due to technical difficulty in applying oxidised regenerated cellulose
Selective reporting (reporting bias) Unclear risk Data presented as numbers of cases and percentages. P values stated for significant outcomes. No omission of outcomes and no subsets of data. No pre‐published protocol identified
Other bias High risk Study used within‐participant design for reporting adhesion formation. However, study was unclear on presentation and analysis of matched data, and no comparative data were presented. As such, we were unable to extract appropriate data from the study