STUDY OBJECTIVE: To compare the efficacy and safety of Cavaterm thermal balloon endometrial ablation with hysteroscopic endometrial resection. DESIGN: Multicenter randomized trial (Canadian Task Force classification I). SETTING: Departments of obstetrics and gynecology in French university hospitals. PATIENTS: Fifty-one women with menorrhagia unresponsive to medical treatment. INTERVENTIONS: Women were randomized to thermal destruction of the endometrium or to hysteroscopic endometrial resection. Women completed preoperative, 6-, and 12-month postoperative pictorial charts to determine Higham blood loss scores and a satisfaction questionnaire. Operative time, discharge time, complication rate, and resumption of normal activities were evaluated for each group. MEASUREMENTS AND MAIN RESULTS:Amenorrhea rates were 36% (95% CI 19%-56%) and 29% (95% CI 8%-51%) in the Cavaterm and the endometrial resection groups at 12 months, respectively (ns). Both treatments significantly reduced uterine bleeding. The median decrease in Higham score at 12 months was significantly higher in women treated by Cavaterm (377, range 108-1300) than in women treated by resection (255, range -82 to 555) (p=.006). A subsequent hysterectomy for recurrent bleeding was performed in 2 women, both previously treated by resection. The rate of women reporting good or excellent satisfaction was 89% (95% CI 72%-98%) in the Cavaterm group and 79% (95% CI 54%-94%) in the resection group at 12 months. Discharge time was significantly lower in women treated by Cavaterm, although postoperative pain at 1 hour was higher. There were no major complications in either group. CONCLUSIONS:Cavaterm thermal balloon ablation was as effective as hysteroscopic endometrial resection to treat menorrhagia, both resulting in a significant reduction in menstrual blood loss and high patient satisfaction.
RCT Entities:
STUDY OBJECTIVE: To compare the efficacy and safety of Cavaterm thermal balloon endometrial ablation with hysteroscopic endometrial resection. DESIGN: Multicenter randomized trial (Canadian Task Force classification I). SETTING: Departments of obstetrics and gynecology in French university hospitals. PATIENTS: Fifty-one women with menorrhagia unresponsive to medical treatment. INTERVENTIONS:Women were randomized to thermal destruction of the endometrium or to hysteroscopic endometrial resection. Women completed preoperative, 6-, and 12-month postoperative pictorial charts to determine Higham blood loss scores and a satisfaction questionnaire. Operative time, discharge time, complication rate, and resumption of normal activities were evaluated for each group. MEASUREMENTS AND MAIN RESULTS:Amenorrhea rates were 36% (95% CI 19%-56%) and 29% (95% CI 8%-51%) in the Cavaterm and the endometrial resection groups at 12 months, respectively (ns). Both treatments significantly reduced uterine bleeding. The median decrease in Higham score at 12 months was significantly higher in women treated by Cavaterm (377, range 108-1300) than in women treated by resection (255, range -82 to 555) (p=.006). A subsequent hysterectomy for recurrent bleeding was performed in 2 women, both previously treated by resection. The rate of women reporting good or excellent satisfaction was 89% (95% CI 72%-98%) in the Cavaterm group and 79% (95% CI 54%-94%) in the resection group at 12 months. Discharge time was significantly lower in women treated by Cavaterm, although postoperative pain at 1 hour was higher. There were no major complications in either group. CONCLUSIONS: Cavaterm thermal balloon ablation was as effective as hysteroscopic endometrial resection to treat menorrhagia, both resulting in a significant reduction in menstrual blood loss and high patient satisfaction.
Authors: Magdalena Bofill Rodriguez; Sofia Dias; Vanessa Jordan; Anne Lethaby; Sarah F Lensen; Michelle R Wise; Jack Wilkinson; Julie Brown; Cindy Farquhar Journal: Cochrane Database Syst Rev Date: 2022-05-31
Authors: L J Middleton; R Champaneria; J P Daniels; S Bhattacharya; K G Cooper; N H Hilken; P O'Donovan; M Gannon; R Gray; K S Khan; J Abbott; J Barrington; S Bhattacharya; M Y Bongers; J-L Brun; R Busfield; M Sowter; T J Clark; J Cooper; K G Cooper; S L Corson; K Dickersin; N Dwyer; M Gannon; J Hawe; R Hurskainen; W R Meyer; H O'Connor; S Pinion; A M Sambrook; W H Tam; I A A van Zon-Rabelink; E Zupi Journal: BMJ Date: 2010-08-16