Clinical trial NCT06712524: Effect of Different Surgical Approaches of 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast-conserving Plastic Surgery
Granulomatous Mastitis
Keywords: Granulomatous mastitis
breast conserving plastic surgery
Aesthetics scores
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Recurrence rate
timeFrame: 2, 3, 5 year
Secondary outcomes:
measure: Aesthetics scores
timeFrame: 2, 3, 5 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
Study officials:
affiliation: Hubei Cancer Hospital
name: Xinhong Wu, Doctor
role: STUDY_CHAIR
References: