Meta-analysis using individual patient data from randomised trials to assess the effectiveness of laparoscopic uterosacral nerve ablation in the treatment of chronic pelvic pain: A proposed protocol

University of Milan, Milano, Lombardy, Italy
BJOG An International Journal of Obstetrics & Gynaecology (Impact Factor: 3.45). 01/2008; 114(12):1580, e1-7. DOI: 10.1111/j.1471-0528.2007.01542.x
Source: PubMed


BACKGROUND: Currently, there are a number of clinical trials, but no international collaboration for collating research on effectiveness of laparoscopic uterosacral nerve ablation (LUNA) for alleviating chronic pelvic pain. OBJECTIVE: Meta-analysis was used by collecting individual patient data (IPD) from the existing trials, to provide a comprehensive assessment of the effectiveness of LUNA that will be generalisable in various clinical contexts. METHODS: IPD will be sought and collected from all relevant (both already finished and continuing) randomised trials identified through previous systematic reviews. After obtaining raw data and cleaning the database, analysis will be of all patients ever randomised based on the intention-to-treat principle using endpoints measured at 12 months following randomisation. PROPOSAL: We will update searches, contact all authors, obtain data in whatever form it can be provided, build a single database, produce results for individual studies, have them verified by original authors, explore of any heterogeneity and reasons behind it and finally pool all raw data in to a meta-analysis using appropriate statistical methods. The project will test the effectiveness of LUNA for women with chronic pelvic pain. It will also motivate collaborating primary investigators to undertake new primary studies to corroborate or improve upon the conclusions derived from the retrospective analysis.

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Available from: Patrick Chien, Sep 04, 2014
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    • "In a recent randomized, controlled trial [10], 80 women were studied with CPP treated with LUNA or vaginal uterosacral nerve resection with a follow-up till 12 months, there were no significant differences between the two study groups with regard to pain relief. The same results were obtained from recent meta-analysis [11] used by collecting individual patient data from the existing trials to provide a comprehensive assessment of the effectiveness of LUNA that will be generalizable in various clinical contexts. Also, in the most recent multicentric, randomized, controlled trial [12] including 487 women with CPP lasting longer than 6 months without or with minimal endometriosis, adhesions, or pelvic inflammatory disease, recruited to the study by consultant gynecological surgeons from 18 UK hospitals, with follow-up conducted by questionnaires mailed at 3 and 6 months and at 1, 2, 3, and 5 years, it concluded that after a median follow-up of 69 months, there were no significant differences reported on the visual analog pain scales for the worst pain between the LUNA group and the no LUNA group for quality of life. "
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    ABSTRACT: The aim of this work is to explore the efficacy , safety, and patients' satisfaction of laparoscopic uterosacral nerve ablation (LUNA) in relief of pain in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score ≤5). The study was a prospective, single-blind, randomized trial with 12 months follow-up. It was conducted at the endoscopy unit of the Gynecology Department of El Minia University Hospital, Egypt. One hundred ninety Egyptian women consented to participate in the study. These eligible patients were randomized using computer-generated tables and were divided into two equal groups, including the control group (diagnostic laparoscopy with no pelvic denervation) and the study group (diagnostic laparoscopy plus LUNA). Diagnostic laparoscopy with or without laparoscopic uterosacral nerve ablation was done. There were no statistically significant difference between both groups regarding the efficacy and the overall success rate (between group I and group II, it was 77.64%, 76.47%, and 74.11% versus 79.06%, 75.58%, and 73.25% at 3, 6, and 12 months, respectively) and the cumulative patients' satisfaction rate (it was 74.11%, 74.11%, and 71.76% versus 75.58%, 75.58%, and 72.09% at 3, 6, and 12 months between group I and group II, respectively; P ≤ 0.05). There was no statistically significant difference between both groups as regards the effectiveness of LUNA in the treatment of primary (spasmodic) and secondary (congestive) dysmenorrhea (P ≤ 0.05), while there was a statistically significant difference between both groups in the treatment of dyspareunia (P ≥ 0.05). LUNA can be a last alternative option in well-selected patients for control of chronic pelvic pain without endometriosis; however, its effectiveness may not extend to other indications. Also, preliminary experience in the treatment of primary deep dyspareunia presents a promising perspective on the management of deep dyspareunia, especially if it will involve a team of social, psychological, and gynecological specialists.
    Full-text · Article · Feb 2011 · Gynecological Surgery
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    • "We undertook an IPD meta-analysis to examine the effectiveness of LUNA in reducing chronic pelvic pain according to a pre-specified protocol (Xiong et al., 2007), developed using recommended methods (Stewart et al., 2008). "
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    ABSTRACT: There have been conflicting results in randomized trials of the effects of laparoscopic uterosacral nerve ablation (LUNA) in chronic pelvic pain. Our objective was to perform a meta-analysis using individual patient data (IPD) to provide the most comprehensive and reliable assessment of the effectiveness of LUNA. Electronic searches were conducted in the Medline, Embase, PsycInfo and Cochrane Library databases from database inception to August 2009. The reference lists of known relevant papers were searched for any further articles. Randomized trials comparing LUNA with no additional intervention were selected and authors contacted for IPD. Raw data were available from 862 women randomized into five trials. Pain scores were calibrated to a 10-point scale and were analysed using a multilevel model allowing for repeated measures. There was no significant difference between LUNA and No LUNA for the worst pain recorded over a 12 month time period (mean difference 0.25 points in favour of No LUNA on a 0-10 point scale, 95% confidence interval: -0.08 to 0.58; P = 0.1). LUNA does not result in improved chronic pelvic pain.
    Preview · Article · Oct 2010 · Human Reproduction Update
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    ABSTRACT: Surgery is often considered the best treatment option in women with symptomatic endometriosis. However, extent and duration of the therapeutic benefit are still poorly defined. The best available evidence on surgery for endometriosis-associated pain has been reviewed to estimate the effect size of interventions in the most frequently encountered clinical conditions. Methodological drawbacks limit considerably the validity of observational, non-comparative studies on the effect of laparoscopy for stage I-IV disease. As indicated by the results of three RCTs, the absolute benefit increase of destruction of lesions compared with diagnostic only operation in terms of proportion of women reporting pain relief was between 30% and 40% after short follow-up periods. The effect size tended to decrease with time and the re-operation rate, based on long-term follow-up studies, was as high as 50%. In most case series on excisional surgery for rectovaginal endometriosis, substantial short-term pain relief was experienced by approximately 70-80% of the subjects who continued the study. However, at 1 year follow-up, approximately 50% of the women needed analgesics or hormonal treatments. Major complications were observed in 3-10% of the patients. Medium-term recurrence of lesions was observed in approximately 20% of the cases, and around 25% of the women underwent repetitive surgery. Pain recurrence and re-operation rates after conservative surgery for symptomatic endometriosis are high and probably underestimated. Clinicians and patients should be aware that the expected benefit is operator-dependent.
    Preview · Article · Feb 2009 · Human Reproduction Update
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