Laparoscopic occlusion compared with embolization of uterine vessels: a randomized controlled trial.
OBJECTIVE
To compare clinical outcome 6 months after treatment with bilateral laparoscopic occlusion of the uterine artery versus uterine leiomyoma embolization.


METHODS
Sixty-six premenopausal women with symptomatic uterine leiomyomata were randomized to treatment with either laparoscopic occlusion of uterine arteries or uterine leiomyoma embolization. The primary outcome was reduction of blood loss from pretreatment to 6 months postoperatively, measured by a Pictorial Bleeding Assessment Chart. Secondary outcomes included patients' own assessment of symptom reduction, postoperative pain assessed using visual analog scales, ketobemidone used postoperatively, complications, secondary interventions, and failures.


RESULTS
Fifty-eight women were included; 6-month follow-up data were available for 28 participants in each group. The percentage reduction in Pictorial Bleeding Assessment Chart scores did not differ between the treatment groups (52% after uterine leiomyoma embolization and 53% after laparoscopy, P=.96). The study had 52% power to detect a 20% difference on the Pictorial Bleeding Assessment Chart. Fewer participants in the group treated with uterine leiomyoma embolization complained of heavy bleeding after 6 months (4% compared with 21%, P=.044). The postoperative use of ketobemidone was higher after uterine leiomyoma embolization (46 mg compared with 12 mg, P<.001).


CONCLUSIONS
Both laparoscopic occlusion of uterine vessels and embolizaton of uterine leiomyoma improved clinical symptoms in the majority of patients. Participants with the laparoscopic procedure had less postoperative pain but heavier menstrual bleeding 6 months after treatment. A larger study and longer follow-up is necessary before a definite conclusion can be made regarding the most effective treatment.


BACKGROUND
(www.ClinicalTrials.gov), NCT00277680


METHODS
I.
Hald
Kirsten
K
Department of Obstetrics and Gynecology, Ullevål University Hospital, University of Oslo, Norway. khald@online.no
Kløw
Nils-Einar
NE
Qvigstad
Erik
E
Istre
Olav
O
D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage; D004621:Embolization, Therapeutic / Q000009:adverse effects; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D007889:Leiomyoma / Q000628:therapy*; D008595:Menorrhagia / Q000628:therapy; D008614:Meperidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D010149:Postoperative Pain / Q000188:drug therapy; D011312:Pressure; D020127:Recovery of Function; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000628:therapy*
D000701:Analgesics, Opioid; D008614:Meperidine; C012394:ketobemidone