Clinical trial NCT05500118: Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
Official title: Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leiomyoma, Uterine
High-Intensity Focused Ultrasound Ablation
Patients Decision Aids
Lead sponsor: Shenzhen Maternity & Child Healthcare Hospital
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-55 years old woman diagnosed with uterine fibroids and without clinical symptoms

Brief 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 criteria: 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 outcomes:
measure: Patient satisfaction after using PDAs
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Maternal and Child Health Hospital
state: Guangdong
Study officials:
References: