Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids

NCT ID: NCT06234670

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-25

Study Completion Date

2025-01-01

Brief Summary

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To research risk factors for recurrence of uterine fibroids and build a prediction model of recurrence of uterine fibroids to facilitate the early detection as well as the early intervention for patients who are prone to recur.

Detailed Description

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Uterine fibroids are the most common benign tumors of female reproductive organs during childbearing age. With the emphasis on fertility preservation and the pursuit of the physical integrity, about 46% of patients prefer the conservative surgery which preserves the uterus. However, the high recurrence rate of uterine fibroids after conservative surgery does cause formidable clinical problems.

According to the literature, the recurrence rate is about 11.7% at one year after myomectomy and would increase steadily. At the eighth year of myomectomy, the recurrence rate is as high as 84.4%. During the long-term follow-up, about one-third of patients eventually require reoperation.

Recurrence not only leads to the recurrence of fibroid-related symptoms such as anemia, abdominal and pelvic pain, frequent urination and urgency, abnormal stool, etc., but also increases the burden of economic and national medical insurance, besides, it even causes serious problems such as psychological disorders, infertility, adverse pregnancy outcomes and malignant transformation, which affecting physical and mental health as well as destroying family happiness and threatening national population security.

Conditions

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Uterine Fibroid Recurrence

Keywords

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Uterine Fibroid Recurrence Risk factor Prediction medel

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with uterine fibroids accepted myomectomy.

Complete the observation and follow-up, to identify the outcome (recur or not recur).

No intervertion

Intervention Type OTHER

This study is a retrospective observational study without intervention.

Interventions

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No intervertion

This study is a retrospective observational study without intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age:18-50 years
2. Diagnosed with uterine fibroids (by ultrasound or pathology)
3. Accept myomectomy.
4. Complete clinical data.

Exclusion Criteria

1. Severe infectious disease
2. Previous history of malignant tumors
3. Incomplete clinical data.
4. Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role collaborator

Wenwen Wang

OTHER

Sponsor Role lead

Responsible Party

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Wenwen Wang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shixuan Wang, Phd

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

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Shixuan Wang

Wuhan, None Selected, China

Site Status

Countries

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China

Central Contacts

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shixuan Wang, Phd

Role: CONTACT

Phone: 86-27-83663078

Email: [email protected]

Wenwen Wang, Phd

Role: CONTACT

Phone: 86-27-83663078

Email: [email protected]

Facility Contacts

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shixuan Wang

Role: primary

Other Identifiers

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V1.0

Identifier Type: -

Identifier Source: org_study_id