Comparing surgical methods for treating granulomatous mastitis
A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis
NA · Hubei Cancer Hospital · NCT06712524
This study is testing whether traditional surgery or breast-conserving plastic surgery is better for people with granulomatous mastitis in terms of recurrence, side effects, appearance, and patient satisfaction.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hubei Cancer Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06712524 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of different surgical approaches on the recurrence rate and aesthetic outcomes in patients with granulomatous mastitis. Participants are divided into two groups: one receiving traditional surgery and the other undergoing breast-conserving plastic surgery. The study aims to compare postoperative recurrence rates, adverse reactions, aesthetic results, and patient satisfaction between the two surgical methods. By exploring these outcomes, the research seeks to provide clearer guidance for clinical decision-making in the treatment of this rare breast condition.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with histologically confirmed granulomatous mastitis who are at low to moderate risk for anesthesia.
Not a fit: Patients with contraindications for surgery, previous history of breast cancer, or serious complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and aesthetic satisfaction for patients with granulomatous mastitis.
How similar studies have performed: While there is limited research specifically on granulomatous mastitis, breast-conserving plastic surgery has shown promise in other breast conditions, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Only the subjects who meet all the following criteria may be included in this study: 1. Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form; 2. 18≤Age≤75 years old, female; 3. Histologically confirmed granulomatous mastitis; 4. low and moderate risk for anesthesia. Exclusion Criteria: The subjects who meet any of the following criteria shall not be included in this study: 1. Absolute and relative contraindication for surgery; 2. Previous history of breast cancer or other malignancies; 3. Pregnancy; 4. Any serious complications which caused patients not suitable to participate this study.
Where this trial is running
Wuhan, Hubei
- Hubei Cancer Hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Hongmei Zheng, Doctor
- Email: zhenghongmeicj@163.com
- Phone: 18971624606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast-conserving Plastic Surgery, Granulomatous Mastitis, Granulomatous mastitis, breast conserving plastic surgery, Aesthetics scores