Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU

Leiomyoma, Uterine Clinical Trial

Official title:

Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500118
• Other study ID #: 2021KFKT030
• Status: Recruiting
• Start date: August 31, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: August 2022
• Source: Shenzhen Maternity & Child Healthcare Hospital
• Contact: Yu Dai, Associate Professor
• Phone: 13828718985
• Email: daiyu829[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;

2. Female with age in 18-55 years old;

3. The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;

4. No contraindications for sedation and analgesia;

5. Patients and their families agree to join this study, and can follow up on time.

Exclusion Criteria:

1. History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;

2. History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;

3. With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;

4. The maximum diameter of leiomyoma is greater than or equal to 5cm;

5. Suspected malignant tumor, such as sarcoma;

6. Those with language communication barriers and unable to cooperate with sedative and analgesic programs;

7. Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyoma, Uterine

Intervention

Other:
• Patients Decision Aids
Patient Decision Aids (PDAs) are an important way to facilitate making decision by patients, helping patients make specific and prudent choices by providing information about treatment options and corresponding outcomes, including benefits and risks, related to their health status. The purpose of PDAs is to encourage patients to participate in decision-making. It makes it easier for patients and doctors to discuss treatment options. It effectively promotes communication between patients and doctors. It can help patients combine their own needs and professional advice to make better, more individualized diagnosis and treatment options.

Locations

Country	Name	City	State
China	Shenzhen Maternal and Child Health Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Maternity & Child Healthcare Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction after using PDAs	The patients in PDAs will undertake the treatment by PDAs. And we will collect the satisfaction after 12 months.	6-12 months