| Methods |
Allocation concealment: stated as maintained securely by storage in sealed, sequentially‐numbered opaque envelopes until the interventions were assigned during the laparoscopic procedure
Randomisation: computer‐generated random number sequences
Blinding: used; participant and investigator blinded throughout the study
Power Calculation: for women with chronic pelvic pain in the absence of endometriosis, in order to have 80% power at the 95% confidence level to detect benefit in 50% of women, assuming 'benefit' in 10% controls, at least 48 participants would be required for analysis following randomisation. For women with endometriosis, in order to have 80% power at 95% confidence level to detect benefit in 90%, assuming benefit in 60% controls undergoing conventional endometriosis surgery, at least 76 participants would be required for analysis following randomisation. Allowing for losses to follow up, it was planned to recruit 50 women with chronic pelvic pain in the absence of endometriosis (achieved) and 80 women with endometriosis (not achieved).
Duration of trial: April 1997 to Dec. 2001.
Follow up: 24 hours, 3 and 12 months. |
| Participants |
Number of women randomised: 123 (108 with dysmenorrhoea)
Number of women analysed: 123
Drop‐outs/withdrawals: 14 were excluded based on laparoscopic findings
Loss to follow up:
24 hours: 1
3 months: 3 (2 LUNA and 0 no LUNA in the population with no endometriosis; 0 LUNA and 1 no LUNA in the endometriosis population).
12 months: 17 (4 LUNA and 2 no LUNA in the population with no endometriosis; 6 LUNA and 5 no LUNA in the endometriosis population)
Inclusion criteria: Women aged 18 to 45 years inclusive; a history of chronic pelvic pain (either dysmenorrhoea, non‐menstrual pelvic pain, defaecatory pain or deep dyspareunia for more than 6 months); no change in medication for the 3 months prior to trial recruitment. Exclusion criteria: previous hysterectomy or pelvic malignancy; previous LUNA; known ovarian cysts; plan for a pregnancy within 12 months; intention to change other medical treatment which could influence pelvic pain scores within 12 months; laparoscopic findings rendering LUNA impossible (for example frozen pelvis with no access to uterosacral ligaments) or the finding of pelvic adhesions which did not appear to be due to endometriosis.
Location: Auckland, New Zealand. |
| Interventions |
2 groups:
Group with endometriosis:
Treatment: LUNA with conservative surgery for endometriosis.
Control: conservative surgery for endometriosis.
Group without endometriosis:
Treatment: LUNA at laparoscopy.
Control: laparoscopy alone. |
| Outcomes |
Changes in non‐menstrual pelvic pain, dysmenorrhoea, deep dyspareunia and dyschezia were assessed primarily by whether there was a decrease in visual analog score for these types of pain of 50% or more from baseline; additionally whether there was a significantly different change in median visual analog score. The numbers requiring further surgery or starting a new medical treatment for pelvic pain and complications were also measured.
Adverse effects: no important intraoperative or postoperative complications occurred (specifically there were no cases of ureteric injury, intraoperative bleeding nor postoperative haematoma formation), other than 2 women who had urinary retention requiring catheterisation within 24 hours of the surgery (both in the endometriosis population not undergoing LUNA). |
| Notes |
137/200 agreed to participate; 14 excluded at laparoscopy; follow up at 12 months: 106/123 (86.2%). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
