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Clinical Trials in China / NCT05500118
Recruiting Observational

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

NCT05500118 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Maternity & Child Healthcare Hospital
Phase
Observational
Started
2022-08-31
Last updated
2022-08-12

Condition(s) studied

Leiomyoma, UterineHigh-Intensity Focused Ultrasound AblationPatients Decision Aids

Investigational drug(s) / intervention(s)

Patients Decision Aids

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Maternal and Child Health Hospital Shenzhen Guangdong Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05500118 on ClinicalTrials.gov ↗ ← All trials in China