Lundorff 2001.
Study characteristics | ||
Methods | Randomised trial (computer‐generated schedule) Third party–blind Multi‐centre: 5 European centres Time of randomisation: at the time of the procedure Power calculation: no | |
Participants | 14 females, 42 years of age, undergoing laparotomy were included; women with systemic disease or inflammatory pelvic condition or receiving any other form of adhesion prevention agent were excluded 77 women were analysed, not clear how many women were randomly assigned Not clear whether intention‐to‐treat analysis was used | |
Interventions | Hyaluronic acid versus Ringer's lactate Route of administration: intraperitoneal Dosage/volume: 300 mL of Intergel or Ringer's lactate Prophylactic antibiotics: no Second‐look laparoscopy performed 6 to 12 weeks after initial procedure | |
Outcomes | Analysed in review
Other outcomes
Pregnancy rates: no |
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Notes | Adhesion scoring system used
mAFS Funded by Lifecore Biomedical Inc |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "At the time of initial surgical procedure, patients were assigned the next available study number corresponding to study device or control solution as determined by the randomization schedule" |
Allocation concealment (selection bias) | Low risk | Study device or control solution was maintained in a sealed carton until decision to enrol the participant was made |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Initial surgical team not blinded to allocation. Not clearly stated whether women were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Third party–blinded review of videotaped second laparoscopy to determine outcome data |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 77 women completed study. No comment on total number randomly assigned |
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 | High risk | Standard deviations for mean adhesion scores appear to be inaccurate for a study with so few women |