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) |
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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 |
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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
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Outcomes | Adhesions at second‐look laparoscopy: 3 to 14 weeks after initial surgery
Adverse effects Pregnancy outcomes: not stated |
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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 |