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

Birmingham Women's Hospital, Metchley Park Road, Edgbaston, Birmingham, UK.
BJOG An International Journal of Obstetrics & Gynaecology (Impact Factor: 3.86). 01/2008; 114(12):1580, e1-7. DOI: 10.1111/j.1471-0528.2007.01542.x
Source: PubMed

ABSTRACT 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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    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.
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    ABSTRACT: In spite of the increasing number of operative laparoscopies performed for endometriosis associated pelvic pain, postoperative symptomatic recurrences are very common. Reoperation is often considered the best treatment option, but the extent and duration of the effect of second-line surgery is still unclear. The best available evidence has been reviewed in order to define the results of repetitive conservative surgery, the effects of pelvic denervating procedures and postoperative medical treatments, as well as the long-term outcome of definitive surgery. Because of the paucity of published data, estimating the real risk of symptomatic recurrence and need for reoperation after repetitive conservative surgery for endometriosis is very difficult. Based on the limited information available, the long-term outcome appears suboptimal, with a cumulative probability of pain recurrence between 20% and 40%, and of a further surgical procedure between 15% and 20%. These figures are probably an underestimate related to drawbacks in study design, exclusions of dropouts, and publication bias and should be considered with caution. Systematic complementary performance of denervating procedures in addition to reoperation cannot be recommended, as only a few symptomatic patients complain of predominantly midline, hypo-gastric pain. The outcome of hysterectomy for endometriosis-associated pain at medium-term follow-up seems quite satisfactory. Nevertheless, about 15% of patients had persistent symptoms, and 3-5% experienced worsening of pain. Concomitant bilateral oophorectomy reduced the risk of reoperation due to recurrent pelvic pain by six times. However, at least one gonad should be preserved in young women, especially in those with objections to the use of oestrogen-progestogens. Medical treatment appears to have limited and inconsistent effects when used for only a few months after conservative procedures. Data on the benefit of prolonged drug regimens with oral contraceptives or progestogen are lacking. The risk of recurrence of endometriosis during hormone replacement therapy seems marginal if combined preparations or tibolone are used and oestrogen-only treatments are avoided. The opportune surgical solution in women with recurrent symptoms after previous conservative procedures for endometriosis should be based on the desire for conception as well as on psychological characteristics. Studies on surgical management of recurrent rectovaginal endometriosis are warranted, due to the peculiar technical difficulties as well as the high risk of complications associated with this challenging disease form.
    European journal of obstetrics, gynecology, and reproductive biology 06/2009; 146(1):15-21. DOI:10.1016/j.ejogrb.2009.05.007 · 1.63 Impact Factor
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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.
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