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 |
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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 |
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Interventions | Dextran 70 versus Ringer's lactate Instilled into peritoneal cavity before closure, after major abdominal surgery |
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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 |
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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) |