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NCT Number: NCT06712524

Effect of Different Surgical Approaches of Granulomatous Mastitis

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hubei Cancer Hospital

Wuhan, Hubei, 430060, China

Location status: Recruiting

Location contact

Xinhong Wu, Doctor

CONTACT

[email protected]

15902736236

Xinjun Liang, Doctor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast-conserving plastic surgery

Procedure

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

Traditional breast surgery

Procedure

Traditional breast surgery

Primary outcomes

  1. Recurrence rate

    Time frame: 2, 3, 5 year

    The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongmei Zheng, Doctor

CONTACT

[email protected]

18971624606

Sponsors and collaborators

Lead sponsor

Hubei Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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