Reviewer's report 
 THE LUNA TRIAL protocol A randomised controlled trial to assess the efficacy of Title: 
Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain 
 3  18 September 2003 Version: Date: 
 Jason A Abbott Reviewer: 
Reviewer's report: 
General 
The authors propose a sound and scientifically valid study that addresses a common problem in the 
area of clinical gynaecology. Its multicentre nature ensures a greater response in terms of 
recruitment and improves external validity. It is a carefully planned protocol with appropriate 
inclusion and exclusion criteria and uses outcome tools that have been validated and are easily achievable without being overburdening for the patient. 
The follow-up methodology is appropriate, however power calculations to determine sample size 
requires that 80% of patients respond to postal questionnaires. Personal review of patients at the 12 
month follow-up, with postal follow up at 24 and 36 months may yeild better numbers and the 
possibility that the power will not be met by the postal questionniare follow-up is very real. The 
authors have of course all ready contemplated this aspect and plan to monitor the loss to follow-up 
throughout the study. 
I have some concerns about the determination of pathology and believe that both the presence and 
severity of endometriosis is under-reported, which may bias the outcomes of this study. Since the 
study requires exclusion of pathology, with the exception of minimal endometriosis, then the population should indeed be a heterogenous one. However the diagnosis of and treatment fo even minimal endometriosis is often poor and is very surgeon dependent. What often appears to be 
minimal disease, such as a small lacunar or subtle peritoneal lesion, when dissected out, may infact 
be more deeply invasive disease. Superficial electrosurgery or laser to these lesions may leave 
much disease behind which in turn may spuriously affect results. 
Apart from clinical efficacy and quality of life, the authors have contemplated the third aspect of the 
research triad - that of cost effectiveness. There has been a considerable amount of work in the 
planning of the protocol and perhaps formal consideration of involving excellent health economics teams in the UK at this early stage would ensure that valuable data is not missed. The assessment 
and costing of complications and adverse events from both diagnostic and intervention arms and 
patient QALY's are of high importance for the uptake of the procedure into a global market that demands justification of its health dollar utilisation. There has been recognition that resource usage is important and that there may be evaluation of data at a later time, though I would encourage the 
incorporation of this aspect early in the study. 
Overall, this is a sound valid and achievable protocol with focused research questions and 
appropriate measures. The authors make comment to all areas that I would suggest change, and 
recognise the realities of clinical research. I wish the study team good and I look forward to the 
results from this study. 
Discretionary Revisions (which the author can choose to ignore) 
Minor Compulsory Revisions (such as missing labels on figures, or the wrong use of a term, which 
the author can be trusted to correct) 
Major Compulsory Revisions (that the author must respond to before a decision on publication can 
be reached) 
 Accept without revision Advice on publication: 
 A paper of considerable merit and interest in its field Level of interest: 
 Acceptable Quality of written English: 
Declaration of competing interests: 
None