The purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.
This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
A(the thickness of the thickest uterine myometrium ≥30mm ):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.
A(the thickness of the thickest uterine myometrium ≥30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.
expulsion rate of the Mirena
Time frame: 1, 3, 6, and 12 months postoperatively
menstrual volume
Time frame: 1, 3, 6, and 12 months postoperatively
dysmenorrhea
Time frame: 1, 3, 6, and 12 months postoperatively
uterine size under ultrasound
Time frame: 1, 3, 6, and 12 months postoperatively
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B(the thickness of the thickest uterine myometrium\<30mm):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.
B(the thickness of the thickest uterine myometrium\<30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.