Methods |
Randomisation by computer‐generated list within 7 days of surgery but method of concealment not described. No blinding, no patient lost to follow up which ranged from 6‐36 months. |
Participants |
Study conducted in Italy (n=77 women). Women aged less than or equal to 40 years with unexplained infertility, and or chronic pelvic pain, with laparoscopic surgery undertaken for moderate or severe endometriosis (disease stage III‐IV). Exclusions were previous medical or surgical treatment for endometriosis or having other diseases which might affect fertility or cause pelvic pain, women without pain symptoms and not desiring children and those with liver or endocrine disease. |
Interventions |
After conservative laparoscopic surgery:
danazol 600 mg daily for 3 months (total n=36, those attempting pregnancy n=11) versus no suppression (total n=41, those attempting pregnancy n=16).
Assessed at 6 monthly intervals. |
Outcomes |
Pelvic pain scores; rAFS staging; pregnancy, definition not given; adverse events; and disease recurrence. |
Notes |
Follow up varied from 6‐36 months. Mean duration of follow up in each group was not compared. No evidence of power calculation, all women randomised were followed up and analysed. No details of funding. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Randomisation by computer‐generated list within 7 days of surgery. |
Allocation concealment? |
Unclear risk |
Unclear, no details provided. |
Blinding?
All outcomes |
High risk |
Open label. |
Incomplete outcome data addressed?
All outcomes |
Low risk |
No patient lost to follow up. |
Free of selective reporting? |
High risk |
Not followed up to live birth. |