Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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 typeInterventional
Ages18 Years and up
SexWomen only
Enrollment240 (estimated)
SponsorHubei Cancer Hospital
Academic / other
Locations1 site (Wuhan, Hubei)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedDecember 2, 2024
Trial IDNCT06712524 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

  • Hubei Cancer Hospital
    Wuhan, Hubei, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.