Surgery for difficult-to-treat granulomatous lobular mastitis
Official title: Randomized Controlled Trial for 'Focus Clearing + Whole Breast Exploration and Washing + One-Stage Micro Plastic Surgery' Treatment for Granulomatous Lobular Mastitis
Run by Wuhan University · NCT04637711 · Data updated 2026-11-12
This study tests a new surgical method for adults with tough-to-treat granulomatous lobular mastitis to see if it helps reduce the chances of the condition coming back while keeping the breast looking good.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Wuhan University Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | November 1, 2020 |
| Main results expected | June 30, 2022 |
| Study ends | June 30, 2027 |
| Registry record updated | November 20, 2020 |
| Trial ID | NCT04637711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 18 or older with extensive granulomatous lobular mastitis lesions who have not yet undergone surgery.
✕Probably not a fit
Patients with granulomatous mastitis of a different etiology or those who are pregnant will 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 a surgical approach for patients with refractory granulomatous lobular mastitis, a benign breast condition that often requires surgical intervention. The proposed method involves lesion removal, whole breast exploration and flushing, followed by one-stage microplastic surgery to minimize recurrence and preserve breast appearance. The study aims to compare this comprehensive surgical technique with traditional extensive lesion excision to determine its effectiveness in reducing postoperative recurrence rates. Participants will be patients aged 18 and older who have not undergone prior surgical treatment for this condition.
Why it matters
Potential benefit: If successful, this approach could significantly reduce recurrence rates of granulomatous lobular mastitis and improve cosmetic outcomes for patients.
How similar studies have gone: While surgical interventions for granulomatous lobular mastitis have been explored, the specific comprehensive approach proposed in this study is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older with granulomatous lobular mastitis * Patients without surgical treatment; * Extensive lesions involving two or more quadrants of the breast, or accompanied by abscess, sinus fistula formation, skin rupture and other complex lesions; * Patients volunteered to participate in the study after informed consent. Exclusion Criteria: * Patients were diagnosed with mastitis with other definite etiology confirmed by pathology * Patients who chose conservative treatment and did not receive surgical treatment * Combined with other basic diseases, unable to tolerate surgery * Patients in pregnancy.
Where it's running
-
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China Recruiting
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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.