Comparing surgical methods for treating granulomatous mastitis
Official title: A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis
Run by Hubei Cancer Hospital · NCT06712524 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | December 2, 2024 |
| Trial ID | NCT06712524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 75 with histologically confirmed granulomatous mastitis who are at low to moderate risk for anesthesia.
✕Probably not a fit
Patients with contraindications for surgery, previous history of breast cancer, or serious complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Hubei Cancer Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Hongmei Zheng, Doctor
- Email: zhenghongmeicj@163.com
- Phone: 18971624606
Similar studies
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This registry collects real-world information from adults with idiopathic granulomatous mastitis to understand how the condition presents, is diagnosed, and progresses in Europe.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.