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

Li 1994.

Methods Unit of randomisation: pelvic sidewall
 Method of randomisation: computer‐generated random numbers
 Time of randomisation: at completion of surgery
 Blinding: assessor unaware of which sidewall was treated
28 participants randomly assigned
 1 exclusion (declined second‐look laparoscopy)
 27 participants (54 pelvic sidewalls) analysed
Trial supported by manufacturers of Interceed (Johnson & Johnson Medical, Ltd., UK)
Participants Patients undergoing adhesiolysis by laparotomy (N = 28; 54 pelvic sidewalls, 1 withdrawal)
Indication for surgery: infertility 21; chronic pelvic pain 6
 Pre‐existing adhesions: yes
 Cause of adhesions: endometriosis 9; PID 10; previous surgery 5; uncertain 3
 Microsurgery: yes
Age, years, mean: 30.4 (SD 4.5)
 No details on participants with infertility
Location: UK
 Timing and duration: 1989 to 1992
Interventions Oxidised regenerated cellulose on pelvic sidewall vs uncovered opposite sidewall
(oxidised regenerated cellulose sutured in 3 cases)
 Other adjuvants used: intraperitoneal hydrocortisone in Intralipid
Second‐look laparoscopy
  1. Timing: 3 to 14 weeks after initial surgery

  2. Surgeon unaware: yes

  3. Adhesiolysis: not stated

Outcomes Adhesions at second‐look laparoscopy: 3 to 14 weeks after initial surgery
  1. Incidence (per pelvic sidewall)

  2. Extent: area, area differential, % improvement

  3. Severity

  4. Area: measured (not specified)


Adverse effects
Pregnancy outcomes: not stated
Notes Documented with photographs and drawings at initial surgery and with video recording at second‐look laparoscopy
 Sponsored by Johnson & Johnson
 Video at second‐look laparoscopy
 No power calculations
 No intention‐to‐treat analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation stated but no details of method provided
Quote: "the assignment of the test side for each woman was carried out before the study and was randomised blocks of two to provide balance"
Allocation concealment (selection bias) Low risk Allocation concealment using envelopes opened intraoperatively, reducing risk of bias
Quote: "a sealed envelope was then opened revealing which of the side walls was to receive Interceed"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unit of randomisation was either right or left side of pelvic wall, so every woman also acted as her own control
Surgeon was not blinded, but treatment allocation was revealed only intraoperatively
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk An independent blinded surgeon performed assessments at second‐look laparoscopy
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 1 exclusion (declined second‐look laparoscopy)
Selective reporting (reporting bias) High risk Data presented as numbers of cases as well as graphically. P values stated for significant outcomes. No omission of outcomes and no subsets of data. Unclear whether power calculation performed
Furthermore, despite 21 participants undergoing adhesiolysis for infertility, no pregnancy outcomes stated
It should also be noted that centres other than Sheffield ‐ Li 1994 ‐ were randomly assigning participants around the UK for a study of oxidised regenerated cellulose and no treatment in the early 1990s (personal communication, A Watson). However, data have never been published
Other bias Unclear risk During surgery, "constant irrigation of the tissue with a physiological solution that contained heparin" was performed. Also, all patients received instillation of hydrocortisone in Intralipid