Surgical Intervention for Refractory Granulomatous Lobular Mastitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorWuhan University
About this trial
Granulomatous lobular mastitis (GLM) belongs to a group of benign diseases, which is mainly treated with glucocorticoids and surgical treatment. Nowadays, in China, surgical treatment has gradually become the mainstream, but the timing and the extent of surgery are still controversial, and different literatures report that the recurrence rate after surgery is 20-50%. Empirical lesion resection is generally used. We believe that the main reason for the high recurrence rate is the incomplete removal of the breast lesions. Because GLM is often characterized with microabscesses formation, empirical resection is likely to have residual lesions that are not visible to the naked eye. In order to reduce the postoperative recurrence rate and protect the breast appearance as much as possible, we propose a surgical plan : granulomatous lobular mastitis "lesion removal + whole breast exploration and flushing + one-stage microplastic surgery". The purpose of this study was to compare this surgical scheme of granulomatous lobular mastitis with existing surgical schemes, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients, and standardize GLM surgical schemes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Focus clearing + whole breast exploration and washing + one-stage micro plastic surgery No Intervention: Extensive lesion excision
Procedure/SurgeryOnly visible lesions and necrotic tissues, such as abscess cavity, sinus tract and fistula, were removed intraoperatively, while normal glands and fat were retained. Preoperative ultrasound was used to locate the lesion area and then the surgical incision was designed. Intraoperative ultrasound examination of latent small lesions, resection of lesions visible under ultrasound, and then a full breast exploration, one finger page incision interval.Radially cut from the base to the subcutaneous, lesions were found and treated locally. After removal of lesion, fully using the syringe, in turn, use of 3% hydrogen peroxide solution, 1% eniodine, saline water is widely jet pulse washing, and around the lesions base. After rinsing, soak in 1% active iodine for 10min, then rinse with normal saline until the liquid is clear. Breast tumor Surgery (Oncoplastic Breast Surgery, OBS) core technology (volume replacement and volume replacement).
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Specific surgical InterventionExperimental treatment 1 intervention
Group B: Extensive lesion excisionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recurrence rate
Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast within one year after surgery was defined as recurrence.
Time frame
Up to 2 yearsSecondary outcomes
1
Breast appearance and cosmetic effect score
Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.
Time frame
Up to 2 years2
Surgical incision healing time
Surgical incision healing time was defined as the time from the first day after the operation to the healing time of the surgical incision. The wound surface was dry, there was no effusion, and no surgical incision complications occurred
Time frame
Up to 2 monthsSponsors and contacts
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Source ClinicalTrials.gov