Authors' objectives:

This review aims to provide a health technology policy assessment of thermal balloon endometrial ablation (TBEA) for dysfunctional uterine bleeding (DUB).

Authors' results and conclusions: A 2004 systematic review of the literature by Garside et al in the United Kingdom, found that overall, there were few significant differences between outcomes for first-generation techniques and TBEA. The outcomes were bleeding, postoperative complications, patient satisfaction, quality of life, and repeat surgery rates. Significant differences were reported most often by one study by Pellicano et al, but this was a level 2 study with methodological weaknesses. Furthermore, according to Garside et al., there was considerable clinical and methodological heterogeneity among the studies in the systematic review. Therefore, a quantitative synthesis using meta-analysis was not done. In Garfield and colleagues review: - TBEA had significantly shorter operating and theatre times (P < .05, < .01, and .0001). - TBEA had fewer intraoperative adverse effects (e.g., reported rates of uterine perforation with RB ablation: from 1% to 5%; TBEA: 0%; rates of cervical laceration with RB: 2% to 5%; TBEA 0%). - They found no studies have directly compared second-generation techniques and hysterectomy; therefore, the comparison can only be indirectly inferred from studies of first-generation techniques and hysterectomy. i. Compared with hysterectomy, TCRE and RB are quicker to perform and result in shorter hospitalization stays and a faster return to work. ii. Hysterectomy results in more adverse effects. iii. Satisfaction with hysterectomy is initially higher, but there is no difference after 2 years. - Studies (level 2 evidence) published after Garsides systematic review support these conclusions. - A study with level 2 evidence reported a significantly higher risk overall of intraoperative complications for RB compared with TBEA (P < .001). This included uterine perforation (RB, 5%; TBEA, 0%) and suspicion of perforation (RB, 2%; TBEA, 0%). - A multicentre long-term case series (level 4 evidence) that examined avoidance of hysterectomy after TBEA for menorrhagia reported that 86% of women who had TBEA did not require a hysterectomy, and 75% did not have any further surgery during a follow-up period of 4 to 6 years. - Several TBEA studies did not provide justification for using general anesthesia over local anesthesia. - Patient preferences for different treatments will depend on a womans desire for amenorrhea as an outcome and/or avoidance of major surgery. Hysterectomy is the only procedure that can guarantee amenorrhea. TBEA will not totally replace hysterectomy in the treatment of DUB, because some women may want cessation of menstruation. - Ensuring that patient expectations are consistent with the outcomes achievable with TBEA is important to obtain high levels of satisfaction. Vilos et al noted that up to one-half of patients who underwent a second attempt at TBEA might have avoided the second procedure with proper preoperative counselling. Meyer et al noted that one consideration for patients with menorrhagia (and no structural lesions) is to return to normal or less blood loss rather than amenorrhea. Patients may have distinct concepts of menstrual bleeding depending on cultural background, and maintaining an acceptable menstrual flow instead of amenorrhea may represent a healthier status.

Authors' recommendations: - TBEA is effective, safe, and cost-effective for patients with DUB. - For women who are not worried about amenorrhea, first-generation techniques offer advantages over hysterectomy. - TBEA is a better alternative to first-generation techniques for DUB, because it is associated with fewer intraoperative adverse effects.

Authors' methods: Systematic review

Project Status: Completed

Year Published: 2004

URL for published report: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_tbea_090104.pdf

URL for additional information: http://www.hqontario.ca/evidence/publications-and-ohtac-recommendations/ohtas-reports-and-ohtac-recommendations/thermal-balloon-endometrial-ablation-for-dysfunctional-uterine-bleeding

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Medical Advisory Secretariat

Contact Address: Medical Advisory Secretariat, 20 Dundas Street West, 10th Floor, Toronto, ON M5G 2N6 CANADA. Tel: 416-314-1092l; Fax: 416-325-2364;

Contact Name: MASinfo.moh@ontario.ca

Contact Email: MASinfo.moh@ontario.ca

Copyright: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care