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

Sekiba 1992.

Methods Unit of randomisation: pelvic sidewall
 Method of randomisation: sealed envelopes
 Time of randomisation: at completion of surgery
 Blinding: double
63 participants (126 pelvic sidewalls)
 No exclusions stated
Trial supported by manufacturers of Interceed (Johnson & Johnson Medical, KK, Tokyo, Japan)
Participants Participants undergoing adhesiolysis by laparotomy
 N = 63
Dropouts: not stated
 Indication for surgery: infertility, known presence of bilateral sidewall adhesions
 Pre‐existing adhesions: yes
 Cause of adhesions: severe endometriosis 28; previous surgery 15; PID 9; no obvious cause 19
 Microsurgery: no
Country: Japan
 Timing and duration: not stated
Interventions Oxidised regenerated cellulose on pelvic sidewall vs uncovered opposite sidewall
Other adjuvants used: none
Second‐look laparoscopy
  1. Timing: 10 days to 14 weeks after initial surgery

  2. Surgeon unaware: yes

  3. Adhesiolysis: not stated

Outcomes Adhesions at second‐look laparoscopy at 10 days to 14 weeks
  1. Incidence (per pelvic sidewall)

  2. Extent: area, area differential, % improvement

  3. Area: measured with sterile ruler

  4. Incidence according to size of de‐peritonealised area

  5. Incidence according to presence or absence of endometriosis

  6. Incidence according to use of sutures

  7. Extent (% improvement) according to size of de‐peritonealised area

  8. Extent (% improvement) according to presence or absence of endometriosis

  9. Extent (% improvement) according to use of sutures


Pregnancy outcomes: nil
Notes Documented with photographs and drawings
 No power calculations
 Duplicate publication
 Supported by Johnson & Johnson
 Multi‐centre trial
Trial also published elsewhere in 1993 (see references)
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: "the pelvic sidewall to be covered was determined randomly using sealed envelopes"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Unit of randomisation was right or left pelvic sidewall, 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 Assessor performing second‐look laparoscopy was blinded to allocation
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No mention of whether withdrawals or dropouts occurred during the study
Selective reporting (reporting bias) Unclear risk Data presented in graphical form for some outcomes. P values stated for significant outcomes. No data subsets reported. No pregnancy outcomes reported despite being an infertility study
Other bias Low risk No other bias identified