Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids

Recurrence Clinical Trial

Official title:

Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234670
• Other study ID #: V1.0
• Status: Not yet recruiting
• Start date: January 25, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Tongji Hospital
• Contact: shixuan Wang, Phd
• Phone: 86-27-83663078
• Email: shixuanwang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3200
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Recurrence
• Uterine Fibroid

Intervention

Other:
• No intervertion
This study is a retrospective observational study without intervention.

Locations

Country	Name	City	State
China	Shixuan Wang	Wuhan	None Selected

Sponsors (2)

Lead Sponsor	Collaborator
Wenwen Wang	Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC	Complete the follow-up, and compare the actual recurrence population with the predicted recurrence population to judge the performance of the prediction model. Use the AUC (Area Under Curve)	through study completion, about June.2025
Secondary	Numbers of risk factors of recurrent uterine fibroids as certained by statistic analysis	To identify the risk factors of recurrent uterine fibroids. We identify the risk factors through statistic analysis. Statistical significance proves to be the symbol of identifycation of risk factors.	about June.2024
Secondary	The recurrence rate of uterine fibroids yearly	To calculate the recurrence rate of uterine fibroids yearly	about Febrary.2024
Secondary	The fertility rate after myomectomy	To research the fertility rate after myomectomy and evaluate the impact of the surgery.	about Febrary.2024
Secondary	The quality of life after myomectomy will be assessed by UFS-QOL,(uterine fibroid symptom and health-related quality of life, UFS-QOL)	To assess the quality of life after myomectomy, we use UFS-QOL.The UFS-QOL, the most popular self-administered instrument in assessing the whole spectrum of fibroid-related symptoms and health-related quality of life among patients with uterine fibroids, was designed in 2002s by James B et.al.; Consisting of eight symptom items and twenty-nine health-related quality of life (HRQL) items of six subscales (concern, activities, energy/mood, control, self-consciousness, and sexual functioning), UFS-QOL is scored with a 5-point scale which demonstrates the patient' state of past 3 months. The final score (range, 0-100) is transformed based on a specific formula. Usually, a higher symptom severity score means more severe symptoms while a higher HRQL score indicates more perfect health	through study completion, about June.2025
Secondary	The degree of abdominal pain after myomectomy will be assessed by VAS(visual analogue scale, VAS)	VAS is the most commonly used one-dimensional measure of pain intensity. The scale consists mainly of a 100 mm straight line with one end indicating "completely painless" and the other end indicating "the most severe pain imaginable" or "extremely painful", etc. Patients will be asked to mark the line at the appropriate location to represent the intensity of the pain they are experiencing at the time	through study completion, about June.2025
Secondary	The blood loss will be assessed by PBLAC (Pictorial Blood Loss Assessment Chart (PBLAC)	The Pictorial Blood Loss Assessment Chart (PBLAC) proposed by Higham JM in 1990 is widely used internationally to evaluate menstrual flow. 1 Menstrual blood loss chart The menstrual blood loss chart is given different scores according to the different degrees of blood staining of each sanitary napkin: mild (1 point), the blood stained area < 1/3 of the whole sanitary napkin; Moderate (5 points): The blood stained area accounts for 1/3~3/5 of the whole sanitary napkin; Severe (20 points): The blood-stained area is basically the entire sanitary napkin.	through study completion, about June.2025