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Effect of Different Surgical Approaches of Granulomatous Mastitis

A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06712524
Enrollment
240
Registered
2024-12-02
Start date
2024-11-01
Completion date
2027-12-31
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast-conserving Plastic Surgery, Granulomatous Mastitis

Keywords

Granulomatous mastitis, breast conserving plastic surgery, Aesthetics scores

Brief summary

The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.

Detailed description

Granulomatous mastitis is a rare benign inflammatory breast disease first described by Kessler and Wollock in 1972. It resembles inflammatory breast cancer disease in imaging and mainly affects women of childbearing age. Treatment methods include steroid therapy, antibiotics and surgical treatment. However, due to the adverse reactions of drug treatment and the high recurrence rate after traditional surgery, there is no definitive preferred treatment form at present, and most clinicians are still in the stage of empirical treatment. Breast-conserving plastic surgery has been widely used by surgeons because it can remove a larger range of breast cancer, so it has higher safety and aesthetics compared with traditional breast conserving surgery. So, if patients with mastitis are treated surgically, will they also benefit from breast-conserving surgery? At present, the commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on. Therefore, this study prospectively grouped mastitis patients who selected surgery, and divided them into traditional surgery group and plastic breast-conserving surgery group. The postoperative recurrence, adverse reactions, aesthetics and satisfaction of the two groups were compared. It is hoped that this study will bring a new research direction for the surgical treatment of mastitis and provide a clearer guiding significance for clinical decision-making.

Interventions

PROCEDUREBreast-conserving plastic surgery

The commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on.

PROCEDURETraditional breast surgery

Traditional breast surgery

Sponsors

Hubei Cancer Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rate2, 3, 5 yearThe recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.

Secondary

MeasureTime frameDescription
Aesthetics scores2, 3, 5 yearThe patients' satisfaction and quality of life after surgery were evaluated by BREAST Q questionnaire. The full score is 100, with higher scores indicating higher patient satisfaction and quality of life. Occurring rate of complications including the occurring rate of infection, hemorrhage, time in hospital in each group were recorded in patients' medical record.

Countries

China

Contacts

Primary ContactHongmei Zheng, Doctor
zhenghongmeicj@163.com18971624606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026