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. 2020 Jul 17;2020(7):CD001298. doi: 10.1002/14651858.CD001298.pub5

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
  1. Presence of adhesions at second look

  2. Improvement or deterioration in adhesion scores at second look

  3. Change in mean adhesion score


Other outcomes
  1. Severity and extent of adhesions

  2. mAFS score categorised by surgical procedure


Pregnancy rates: no
Notes Adhesion scoring system used
mAFS
Funded by Lifecore Biomedical Inc
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