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

Rosenberg 1984.

Study characteristics
Methods Truly randomised trial (method not stated)
Time of randomisation
Double‐blinded—participant and primary surgeon (conducting initial surgery and second‐look laparoscopy)
Power calculation: no
ITT: no
Location: single‐centre—Medical College of Virginia Reproductive and Infertility Service
Timing and duration: 1 Aug 1981 to 31 July 1982; 1 year
Participants women scheduled to undergo major abdominal infertility surgical procedures (N = 46)
Number undergoing second‐look laparoscopy: 44 (2 women randomly assigned but did not undergo second‐look laparoscopy—no reason stated in published data)
Timing second‐look laparoscopy: 6 weeks
Blinding at second‐look laparoscopy: yes
Exclusion criteria: none stated
Interventions Dextran 70 versus Ringer's lactate
Instilled into peritoneal cavity before closure, after major abdominal surgery
Outcomes American Fertility Society "Classification of endometriosis" score—adhesions component of score at second‐look laparoscopy
Change in score from initial surgery to second‐look laparoscopy
Notes Standard deviations not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No comment in published text on randomisation method
Allocation concealment (selection bias) Low risk Allocated treatment prepared outside of operating theatre by research pharmacist. Brought to theatre in standardised bottle labelled only with patient's name and substance code
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not clearly stated that women blinded. Surgeon performing initial procedure blinded, however, other members of surgical team not blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Initial surgeon performed both initial and SLL outcome assessment and was blinded to allocation.
Incomplete outcome data (attrition bias)
All outcomes High risk 46 women enrolled and randomised, two did not undergo SLL, however, no information provided regarding the reasons for this
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 Results reported in graphical format without numerical data provided for SDs or standard error of the mean (SEMs)