| Methods |
Allocation Concealment: unclear.
Randomisation: randomisation list, no other details reported.
Blinding: unclear.
Power Calculation: sample size based on assumption that dysmenorrhoea would resolve in 50% controls and 80 ‐ 90% PSN group. Number of included patients gives 80% power for a difference of 30% 90% power for a difference of 40%, 0.05 level of significance.
Duration of trial: Recruitment from June 1986 to Jan 1990. Follow up of all women for at least one year. |
| Participants |
Number of women randomised: 78.
Number of women analysed: 71.
Drop‐outs/withdrawals: 7 women did not accept randomisation.
Inclusion criteria: women with endometriosis stage III or IV undergoing conservative surgery, moderate or severe midline or midline and lateral menstrual pelvic pain (dysmenorrhoea).
Diagnosis: gastro, urologic and orthopaedic evaluation to exclude other causes of pelvic pain, endometriosis confirmed at surgery.
Age: Control group mean 31.1, SD 3.6; PSN surgery group mean 32.5, SD 4.2.
Location: Milan, Italy. |
| Interventions |
Treatment: presacral neurectomy with conservative surgery for endometriosis.
Control: conservative surgery for endometriosis. |
| Outcomes |
Dysmenorrhoea, measured by a 0 ‐10 analog scale and by a multidimensional scale which included limitation of working ability, systemic symptoms, and need for analgesics. Data reported as mild, moderate or severe pain prior to surgery and 12 months following surgery.
Adverse effects. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
