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Systematic review of ultrasound-assisted lipoplasty: update and reappraisal |
Cooter R, Robinson D, Babidge W, Mutimer K, Kiroff G, Wickham P, Chapman A, Maddern G |
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Authors' objectives To assess the safety and efficacy of ultrasound-assisted lipoplasty (UAL) in comparison with traditional lipoplasty techniques.
This abstract is based on a report of an update of an earlier review. A journal article reports the original review together with the information added in the update (see Other Publications of Related Interest).
Searching For the original review, MEDLINE (from 1984 to December 1998), Current Contents (from 1993 to December 1998), EMBASE (from 1974 to December 1998) and the Cochrane Library (Issue 4, 1998) were searched for English language articles. The same databases were searched from January 1999 to April 2000 for the update. The search terms used were given in the report. Manufacturers and distributors of ultrasonic-assisted liposuction devices were contacted to identify ongoing and unpublished studies.
Study selection Study designs of evaluations included in the reviewRandomised controlled trials (RCTs), controlled clinical trials (CCTs), case series and case reports were eligible for inclusion.
Specific interventions included in the reviewStudies of UAL and studies of suction-assisted lipoplasty (SAL) were included in the original review. The update did not include studies of SAL by itself: the included studies had to address UAL as well.
Participants included in the reviewAdults in any case setting, who were described as having excess deposits of undesirable subcutaneous tissue, were eligible for inclusion. Patients with deposits of subcutaneous tissue from a metabolic, pharmacological or known pathological condition were included in the review only if data from patients with localised subcutaneous tissue collections were presented separately in the same study.
Outcomes assessed in the reviewIn the original review the primary outcomes were independent measures of contour improvement, surgical complications, duration of the operation, blood loss and surgeon fatigue. The secondary outcomes were costs, pain, reliability and acceptability and quality of life. Potential mutagenic DNA damage due to ultrasonic effects (in vitro as well as in vivo) was an additional outcome addressed in the update.
How were decisions on the relevance of primary studies made?One reviewer selected the studies for inclusion and a surgeon checked the decisions.
Assessment of study quality The report did not mention a validity assessment, only that the studies were stratified in a hierarchy of evidence from level I (best) to level IV (worst). The journal article (see Other Publications of Related Interest) reported that the studies were assessed for methodological quality, including the appropriateness of the study exclusion criteria, possible confounding variables and the quality of reporting. The authors did not state how the papers were assessed for validity, although this appears to have been done by one reviewer.
Data extraction The authors did not state how the data were extracted for the review, although this appears to have been done by one reviewer. The efficacy and adverse outcomes reported in the included studies were extracted together with details of the liposuction procedures and equipment used, and the duration of ultrasound application.
Methods of synthesis How were the studies combined?The original review and the additional findings from the update were summarised in a narrative format.
How were differences between studies investigated?Studies of UAL or SAL were addressed separately from studies of the mutagenic potential of ultrasound. Some differences between some of the studies can be derived from tables in the report.
Results of the review UAL and SAL: 17 studies (4 RCTs, 3 CCTs, 9 case series, 1 case report) were included in the original review . The update added two more case series. The number of participants was not reported.
Mutagenic potential of ultrasound: 19 papers were included. Only one was a clinical study comparing long-term occupational ultrasound exposure to unexposed controls (cohort study); the other 18 were in vitro studies (performed on collections of cells or DNA).
UAL and SAL.
The RCTs included in the original review were of a poor quality and measured subjective outcomes without blinding. The other studies also had methodological flaws. Evidence comparing the efficacy and safety of UAL and SAL was lacking. The low-quality evidence that was available suggested that UAL might be associated with not only reduced surgeon fatigue, but also with increased operating times, slower aspiration rates and an increased learning curve. The most commonly reported complications with ultrasound were thermal entry site burns, seromas, Reston foam blisters, and temporary neuropraxia. No deaths were reported in the included studies. The two studies added in the update were not considered by the authors to warrant a revision of the original conclusions.
Mutagenic potential of ultrasound.
A retrospective cohort study found significantly more micronucleated lymphocytes in men exposed to occupational ultrasound (for a mean of 5 years) in comparison with unexposed controls. Results from the in vitro studies could not be easily extrapolated to inform realistic estimates of the mutagenic risks of ultrasound in humans.
Authors' conclusions The authors concluded that the evidence base was inadequate to determine the safety and efficacy of UAL. In addition, that the potential for DNA damage needs to be investigated in vivo using animal models.
CRD commentary Clear inclusion criteria were stated for the participants and outcomes. However, the review question was not entirely clear with respect to the intervention, and that aspect also differed between the original review and the update. Several sources were searched, but publication and language bias may have influenced the findings. Details of the individual studies included in the original review were not provided, although some details of the studies added in the update were tabulated in the report. There was only a minimal assessment of study quality and the results of that were only provided (in the report) for studies added in the update. The results of the original review (only reported in the journal article) were presented as a narrative that did not clearly distinguish studies that met the inclusion criteria from a predominance of other information. The narrative synthesis was appropriate given the dissimilarities between the studies, but the studies were not synthesised adequately in the narrative summary.
The authors' conclusion that the evidence is inadequate is apt given the lack of information to conclude otherwise. The recommendations for practice do not appear to have been based on those studies meeting the stated inclusion criteria for this review.
Implications of the review for practice and research Practice: The authors stated that the technical aspects of UAL can be carried out safely if certain fundamental principles are observed, such as appropriate patient selection, appropriate anatomical sites, attention to the operative technique, careful selection of infiltrating solutions, adequate fluid management, good patient monitoring and documentation, and post-operative compression agents. However, these recommendations were derived from sources of information other than those studies meeting the stated inclusion criteria for their review.
Research: The authors stated that UAL requires more extensive and rigorous evaluation, and that the potential damaging effects of ultrasound needs to be investigated. There was mention of a prospective multicentre cohort study to be undertaken in the USA.
Bibliographic details Cooter R, Robinson D, Babidge W, Mutimer K, Kiroff G, Wickham P, Chapman A, Maddern G. Systematic review of ultrasound-assisted lipoplasty: update and reappraisal. North Adelaide, S. Australia, Australia: Royal Australasian College of Surgeons, Australian Safety and Efficacy Register of New Interventional Procedures (ASERNIP) - Surgical. ASERNIP-S Report; 17. 2002 Other publications of related interest Cooter R, Babidge W, Mutimer K, Wickham P, Robinson D, Kiroff G, et al. Ultrasound-assisted lipoplasty. Aust N Z J Surg 2001;71:309-17.
Indexing Status Subject indexing assigned by CRD MeSH Lipectomy /therapeutic use; Surgery, Plastic; Ultrasonic Therapy AccessionNumber 12002008391 Date bibliographic record published 31/03/2004 Date abstract record published 31/03/2004 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
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