Effect of Different Surgical Approaches of Granulomatous Mastitis

Not Applicable

Recruiting

• Conditions: Breast-conserving Plastic Surgery; Granulomatous Mastitis

• Registration Number: NCT06712524
• Lead Sponsor: Hubei Cancer Hospital

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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence rate	2, 3, 5 year	The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.

Secondary Outcome Measures

Name	Time	Method
Aesthetics scores	2, 3, 5 year	The 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.

Trial Locations

Locations (1)

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China