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

Keckstein 1996.

Methods Unit of randomisation: ovary
 Method of randomisation: toss of a coin
 Time of randomisation: at completion of surgery
Blinding: surgeon at second‐look laparoscopy not aware of allocation
Participants Patients undergoing bilateral ovarian cystectomy by laparoscopy
N = 25
 14 participants with bilateral endometriomas, 6 with ovarian cysts and endometriosis, and 5 with ovarian cysts only
 Dropouts: 8, not stated why
 Some participants also underwent adhesiolysis and removal of endometriosis
Indication for surgery: ovarian cysts; not specifically participants with infertility
 Pre‐existing adhesions: some (but participants with dense adhesions excluded)
 Cause of adhesions: not stated (endometriosis included)
 Microsurgery: no
 Timing not stated
Country: Germany (1 centre)
Interventions Oxidised regenerated cellulose on ovary vs uncovered opposite ovary
Other adjuvants used: none
Suturing: 9 of 17 in the oxidised regenerated cellulose group; 3 of 17 in the non‐oxidised regenerated cellulose group
Second‐look laparoscopy
  1. Timing: 8 to 30 weeks after initial surgery

  2. Surgeon unaware: not stated

  3. Adhesiolysis: not stated

Outcomes Adhesions at second‐look laparoscopy: 8 to 30 weeks
  1. Incidence (per ovary) of de novo adhesions

  2. Severity: graded as filmy, vascular, or dense

  3. Area: estimated % of ovarian surface


Adverse effects
 Pregnancy data nil
Notes Power calculations: nil
 Analysis sponsored by Johnson & Johnson only after study was completed
 First presented as abstract in 1994
 No photographic or video documentation
 No intention‐to‐treat analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Coin tosses were used as a simple method of randomisation
Quote: "the random assignment of one ovary for wrapping with Interceed was revealed to the surgeon after a coin toss"
Allocation concealment (selection bias) Low risk Coin toss took place intraoperatively
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unit of randomisation was each ovary, so all women acted as their own controls
Surgeon was not blinded, but treatment allocation took place intraoperatively: "at the end of cystectomy the random assignment of one ovary for wrapping with Interceed [...] was revealed to the surgeon after a coin toss"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Study does not state whether the assessor during SLL was blinded to initial treatment
Incomplete outcome data (attrition bias) 
 All outcomes High risk 8 dropouts (n = 25); no reasons stated as to why participants did not return for SLL
Selective reporting (reporting bias) Unclear risk Data presented as numbers of cases and percentages, as well as graphically. P values stated for significant outcomes. No omission of outcomes and no subsets of data. However, no pre‐published protocol identified
Other bias Low risk No other bias identified