Wallweiner 1998.
Methods | Unit of randomisation: participant Method of randomisation: not stated Time of randomisation: at completion of surgery Blinding: yes | |
Participants | Women (N = 40) undergoing initial treatment for endometriosis by laparoscopy‐vaporisation of peritoneal deposits, excision of endometrioma, reconstructive surgery, and adhesiolysis
No dropouts Mean age, years: 27 Pre‐existing adhesions: yes Cause of adhesions: endometriosis Microsurgery: no Location: Germany Timing: not stated 7 dropouts: 4 were pregnant, 2 withdrew, and 1 had such dense adhesions at laparoscopy of both ovaries that no assessment could be made Pre‐existing adhesions: nil Mean age, years: 28 No other cause of infertility found Timing: 1994 to 1995 Country: UK (1 centre) |
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Interventions | Oxidised regenerated cellulose applied to all injured visceral peritoneal surfaces of ovary,tubes and uterus vs no treatment Other adjuvants used: none Second‐look laparoscopy
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Outcomes | Adhesions at second‐look laparoscopy: 3 to 6 months later
Adverse outcomes: unknown Pregnancy: not stated |
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Notes | Power calculations: nil Sponsorship: not stated Documentation: video | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not clearly stated |
Allocation concealment (selection bias) | Unclear risk | Not clearly stated in text |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated whether initial surgeon was blinded; however as control was no treatment, this appears unlikely. Not clearly stated whether participants were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | States that evaluator performing second‐look laparoscopy was not familiar with the initial operative site, but does not clearly state that evaluator was blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of whether withdrawals or dropouts occurred during the study |
Selective reporting (reporting bias) | Unclear risk | Data reported as numbers in a dichotomous score. P values stated. No conversion or subsets of data. No pre‐publication protocol for reference purposes |
Other bias | Low risk | No other bias identified |
AFS: American Fertility Society.
BBT: basal body temperature.
CI: confidence interval.
GnRH: gonadotrophin‐releasing hormone.
HSG: hysterosalpingogram.
mAFS: modified American Fertility Society.
PID: pelvic inflammatory disease.
PTFE: polytetrafluoroethylene.
SD: standard deviation.
SEM: standard error of the mean.
SLL: second‐look laparoscopy.