Jansen 1990.
| Study characteristics | ||
| Methods | Truly randomised trial (random number sequence) Timing of randomisation: not stated Factorial design Power calculation: yes Location: Sydney, Australia Timing and duration: not stated | |
| Participants | Infertile women undergoing open gynaecological microsurgery Condition: pelvic adhesions, endometriosis, or both Surgery performed: adhesiolysis; excision of endometriosis Pre‐existing adhesions: 75 women Age: not stated Duration infertility: not stated Infertility work‐up: not stated Number randomly assigned: 95 (no exclusions stated) Number analysed: 93 for comparison 1; 95 for comparison 2 Timing second‐look laparoscopy: 10 or 12 days postoperative Blinding at second‐look laparoscopy: not stated | |
| Interventions | 1. Promethazine versus no treatment
Route of administration: systemic (oral and IM)
Dosage/volume: 50 mg oral 6 hours preoperatively and 50 mg IM intraoperatively 2. Postoperative steroids versus no treatment Route of administration: systemic (oral) Dosage/volume: postoperative prednisone 25 mg oral twice a day for 4 days, then 25 mg daily until SLL Other adjuvants: all women received systemic preoperative (50 mg prednisone 8 hours preoperatively) and intraoperative (24 mg dexamethasone IV) steroids Prophylactic antibiotics: yes |
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| Outcomes | Analysed in review Adhesions at second‐look laparoscopy
Other outcomes: adhesions at second‐look laparoscopy
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| Notes | Adhesion scoring system used
Modified American Fertility Society endometriosis scoring system (range 0 to 27)
Data obtained from review article and investigator himself Some study information supplied in correspondence from study authors |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated that study was randomised, but method not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
| 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 | Low risk | |