Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

NCT ID: NCT06478992

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-06-30

Brief 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.

Detailed Description

This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.

Conditions

Adenomyosis; Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

the thickness of the thickest uterine myometrium ≥30mm

Group Type: OTHER

A:hysteroscopic suture fixation of Mirena

Intervention Type: PROCEDURE

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: simple Mirena placement under hysteroscopy

Intervention Type: PROCEDURE

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.

the thickness of the thickest uterine myometrium <30mm

Group Type: OTHER

B: hysteroscopic suture fixation of Mirena

Intervention Type: PROCEDURE

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：simple Mirena placement under hysteroscopy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (VAS) ≥40mm or menstrual volume score (PBAC) ≥100;

• Adenomyosis was confirmed by ultrasound or magnetic resonance imaging (MRI);

• The uterine volume measured by transvaginal gynecological three-dimensional ultrasound was more than 150cm3 and less than 280cm3 (the volume was about 280cm3 at 10 weeks of pregnancy); ④ A strong desire to preserve the uterus; ⑤ No fertility requirements within nearly one year;

• Premenopausal women aged ≥18 years old; ⑦ Willing and able to abide by the study protocol, and have the ability to clearly judge the amount of menstruation and the degree of pain.

Exclusion Criteria

• Presence of contraindications to Mirena (known or suspected pregnancy, current pelvic inflammatory disease or recurrent pelvic inflammatory disease, lower genital tract infection, postpartum endometritis, infectious abortion within the past 3 months, cervicitis, cervical dysplasia, uterine or cervical malignant lesions, progestin-dependent tumors, abnormal uterine bleeding of unknown cause, congenital or acquired uterine abnormalities, these include fibroids that deform the cervix, conditions that increase susceptibility to infections, acute liver diseases or tumours, allergy to active ingredients or excipient);

• Malignant tumors (including reproductive system and other systems);

• Acute stage of heart, liver and kidney failure or other patients who cannot tolerate operation;

• The history of Mirena displacement or expulsion;

• Ultrasound showed the presence of ovarian chocolate cyst; ⑥ The presence of deep endometrial nodules by gynecological examination;

• The presence of intramural or subserous myoma ≥3cm or any size of uterine submucosal myoma (type 0, 1, 2); ⑧ Patients who are unwilling to participate in the study or who were considered by the investigators to be unsuitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IIT-20220610-0097-02

Identifier Type: -

Identifier Source: org_study_id