Surgery for difficult-to-treat granulomatous lobular mastitis
Randomized Controlled Trial for 'Focus Clearing + Whole Breast Exploration and Washing + One-Stage Micro Plastic Surgery' Treatment for Granulomatous Lobular Mastitis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Wuhan University Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04637711 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 or older with extensive granulomatous lobular mastitis lesions who have not yet undergone surgery.
Not a fit: Patients with granulomatous mastitis of a different etiology or those who are pregnant will not benefit from this study.
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 performed: While surgical interventions for granulomatous lobular mastitis have been explored, the specific comprehensive approach proposed in this study is relatively novel.
Eligibility criteria
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 this trial is running
Wuhan, Hubei
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
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.