Evaluation of the Efficacy and Safety of Microwave Ablation of Uterine Adenomyosis Under Improved Ultrasound Guidance

N/ANot Yet RecruitingNCT06751264

Peking University Aerospace Center Hospital137 enrolled

Overview

This study aims to compare the safety and efficacy of segmental power adjustment combined with uterine cavity hydro-isolation in microwave ablation of adenomyosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

137

Conditions

Adenomyosis of Uterus

Interventions

Peritoneal combined with intrauterine water isolationPROCEDURE

On the basis of the conventional peritoneal water isolation group, the improved technology group added additional intrauterine water isolation, and continued to inject ice saline to separate the endometrium on both sides.

Peritoneal water isolationPROCEDURE

Transabdominal injection of saline into the abdominal cavity to achieve complete separation of the uterus from the surrounding organs and structures

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. UFs or AM diagnosed by pathology and ultrasound； 2. Relevant symptoms such asabnormal uterine bleeding, secondary anemia, progressive dysmenorrhea and enlargement of the uterus； 3. Voluntarily undergo MWA； 4. a confirmed available safe transabdominal puncture path； Exclusion Criteria: 1. Pregnancy or malignancy； 2. Severe and uncorrectable coagulation disorders； 3. Severe cardiac, liver, and renal dysfunction； 4. Anesthesia allergy.

Outcomes

Primary Outcomes

The rates of endometrial injury

Observe the differences in the rates of endometrial injury between two groups

Time frame: From enrollment to the end of treatment at 3 months

Secondary Outcomes

The reduction rate of adenomyosis volume

Observe the reduction rate of adenomyosis volume between two groups

Time frame: From enrollment to the end of treatment at 1 year

complication

The complication rate between the two groups was compared

Time frame: From enrollment to the end of treatment at 1 year

Central Contacts

Lei Liang, PHD

CONTACT

010-59971599 lianglei_csk@126.com

Data from ClinicalTrials.gov

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