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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Leiomyoma, Uterine High-Intensity Focused Ultrasound Ablation Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Patients Decision Aids

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Shenzhen Maternal and Child Health Hospital

Shenzhen, Guangdong, 518000, China

Location status: Recruiting

Location contact

Ping Jin, Professor

CONTACT

[email protected]

13925206896

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;
Female with age in 18-55 years old;
The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;
No contraindications for sedation and analgesia;
Patients and their families agree to join this study, and can follow up on time.

Exclusion criteria

History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;
History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;
With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;
The maximum diameter of leiomyoma is greater than or equal to 5cm;
Suspected malignant tumor, such as sarcoma;
Those with language communication barriers and unable to cooperate with sedative and analgesic programs;
Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).

Treatment and study plan

Patients Decision Aids

Other

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.

Primary outcomes

Patient satisfaction after using PDAs

Time frame: 6-12 months

The patients in PDAs will undertake the treatment by PDAs. And we will collect the satisfaction after 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Dai, Associate Professor

CONTACT

[email protected]

13828718985

Sponsors and collaborators

Lead sponsor

Shenzhen Maternity & Child Healthcare Hospital

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2027
First posted: Aug 12, 2022
Registry last updated: Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting