Methods |
Allocation Concealment: unclear.
Randomisation: computer‐generated randomisation sequence.
Blinding: double; participant and research nurse.
Power Calculation: done; sample for 90% power was 22 women in each group.
Duration of trial: women assessed at 3 and 6 months post operative (recruitment occurred over 33 months Feb.1995 to Nov. 1997). |
Participants |
Number of women randomised: 51.
Number of women analysed: 46 at 6 months.
Drop‐outs/withdrawals: 5 (1 became pregnant and 4 were lost to follow up). However data points for to 14 women were missing for some analyses.
Inclusion criteria: women with history and physical or laparoscopic examination suggestive of endometriosis who had not received medical treatment for endometriosis within the last 6 months, and had not previously undergone surgical treatment of their disease.
Exclusion criteria: stage IV disease or any other pathology that may have been responsible in whole, or in part for their symptoms.
Diagnosis: at laparoscopy those with stage IV disease or other pathology were excluded.
Age: mean 28 (20 to 41).
Location: Surrey, UK. |
Interventions |
Treatment: LUNA with laparoscopic treatment of all visible endometriosis.
Control: laparoscopic treatment of all visible endometriosis . |
Outcomes |
Dysmenorrhoea, measured by linear analogue scale (0 ‐ 10) and pain scoring questionnaire.
Adverse effects. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |