Diamond 1998.
Study characteristics | ||
Methods | True randomisation (randomisation list) Time of randomisation: preoperative Multi‐centre study: 23 centres in USA Power calculation: no Double‐blinding: yes | |
Participants | Females 18 years of age and older undergoing laparotomy for gynaecological surgery Exclusion criteria: pregnancy, cancer, PID Number of women randomly assigned: 277 Number of women undergoing second‐look laparoscopy evaluation: 245 | |
Interventions | 0.4% hyaluronic acid versus phosphate‐buffered saline as irrigant, not instillant Route of administration: intraperitoneal Dosage/volume: maximum of 1 L of SepraCoat or placebo Second‐look laparoscopy: average of 40 days later | |
Outcomes | Analysed in review
Other outcomes
Pregnancy rates: no |
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Notes | Adhesion scoring system used: own system 0 = no adhesions 1 = up to 25% 2 = 26%‐50% 3 = more than 50% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Before their initial procedure, patients at each centre were assigned randomly according to a computer‐generated list" |
Allocation concealment (selection bias) | Low risk | Quote: "The surgeons who performed the initial procedures, the surgeons who performed the second‐look laparoscopies, and the independent reviewer were blinded to randomisation" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Initial surgeons were blinded to the solution being used in each woman. Not clearly stated whether women were blinded to allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "A videotape recording of the abdominopelvic cavity was made at this time [of second‐look laparoscopy]; the video was reviewed later by a blinded, independent reviewer" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Data presented in full for all outcomes specified, however no study protocol or trial registry identified for comparison |
Other bias | Low risk | Sponsored by Genzyme Corporation |