Clinical trial NCT06234670: Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids
Official title: Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Uterine Fibroid
Recurrence
Keywords: Uterine Fibroid
Recurrence
Risk factor
Prediction medel
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
First posted: 2024-01-31
Enrollment: 3200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with uterine fibroids and accept myomectomy.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC
timeFrame: through study completion, about June.2025
Secondary outcomes:
measure: Numbers of risk factors of recurrent uterine fibroids as certained by statistic analysis
timeFrame: about June.2024
measure: The recurrence rate of uterine fibroids yearly
timeFrame: about Febrary.2024
measure: The fertility rate after myomectomy
timeFrame: about Febrary.2024
measure: The quality of life after myomectomy will be assessed by UFS-QOL,(uterine fibroid symptom and health-related quality of life, UFS-QOL)
timeFrame: through study completion, about June.2025
measure: The degree of abdominal pain after myomectomy will be assessed by VAS（visual analogue scale, VAS）
timeFrame: through study completion, about June.2025
measure: The blood loss will be assessed by PBLAC (Pictorial Blood Loss Assessment Chart (PBLAC)
timeFrame: through study completion, about June.2025
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Shixuan Wang
state: None Selected
Study officials:
affiliation: Huazhong University of Science and Technology
name: Shixuan Wang, Phd
role: STUDY_CHAIR
References: