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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hongmei Zheng, Doctor
- Phone Number: 18971624606
- Email: zhenghongmeicj@163.com
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430060
- Recruiting
- Hubei Cancer Hospital
-
Principal Investigator:
- Xinjun Liang, Doctor
-
Contact:
- Xinhong Wu, Doctor
- Phone Number: 15902736236
- Email: wuxinhong_9@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Only the subjects who meet all the following criteria may be included in this study:
- Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
- 18≤Age≤75 years old, female;
- Histologically confirmed granulomatous mastitis;
- low and moderate risk for anesthesia.
Exclusion Criteria:
The subjects who meet any of the following criteria shall not be included in this study:
- Absolute and relative contraindication for surgery;
- Previous history of breast cancer or other malignancies;
- Pregnancy;
- Any serious complications which caused patients not suitable to participate this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breast-conserving plastic surgery group
Breast-conserving plastic surgery
|
The commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on.
|
|
Active Comparator: Traditional breast surgery group
Traditional breast surgery
|
Traditional breast surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence rate
Time Frame: 2, 3, 5 year
|
The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.
|
2, 3, 5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aesthetics scores
Time Frame: 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. |
2, 3, 5 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Xinhong Wu, Doctor, Hubei Cancer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LLHBCH2024YN-093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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