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NOT YET RECRUITING
NCT06478992
NA

Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

Sponsor: First People's Hospital of Hangzhou

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter Randomized Controlled Trial of Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-06-30

Completion Date

2026-06-30

Last Updated

2024-06-27

Healthy Volunteers

No

Interventions

PROCEDURE

A:hysteroscopic suture fixation of Mirena

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.

PROCEDURE

A: simple Mirena placement under hysteroscopy

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.

PROCEDURE

B: hysteroscopic suture fixation of Mirena

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.

PROCEDURE

B:simple Mirena placement under hysteroscopy

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.