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NCT Number: NCT04637711

Surgical Intervention for Refractory Granulomatous Lobular Mastitis

Granulomatous lobular mastitis (GLM) belongs to a group of benign diseases, which is mainly treated with glucocorticoids and surgical treatment. Nowadays, in China, surgical treatment has gradually become the mainstream, but the timing and the extent of surgery are still controversial, and different literatures report that the recurrence rate after surgery is 20-50%. Empirical lesion resection is generally used. We believe that the main reason for the high recurrence rate is the incomplete removal of the breast lesions. Because GLM is often characterized with microabscesses formation, empirical resection is likely to have residual lesions that are not visible to the naked eye. In order to reduce the postoperative recurrence rate and protect the breast appearance as much as possible, we propose a surgical plan : granulomatous lobular mastitis "lesion removal + whole breast exploration and flushing + one-stage microplastic surgery". The purpose of this study was to compare this surgical scheme of granulomatous lobular mastitis with existing surgical schemes, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients, and standardize GLM surgical schemes.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location status: Recruiting

Location contact

Liuyi Lan

CONTACT

[email protected]

18972865915 ext. 86

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18 years or older with granulomatous lobular mastitis
  • Patients without surgical treatment;
  • Extensive lesions involving two or more quadrants of the breast, or accompanied by abscess, sinus fistula formation, skin rupture and other complex lesions;
  • Patients volunteered to participate in the study after informed consent.

Exclusion criteria

  • Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
  • Patients who chose conservative treatment and did not receive surgical treatment
  • Combined with other basic diseases, unable to tolerate surgery
  • Patients in pregnancy.

Treatment and study plan

Focus clearing + whole breast exploration and washing + one-stage micro plastic surgery No Intervention: Extensive lesion excision

Procedure

Only visible lesions and necrotic tissues, such as abscess cavity, sinus tract and fistula, were removed intraoperatively, while normal glands and fat were retained. Preoperative ultrasound was used to locate the lesion area and then the surgical incision was designed. Intraoperative ultrasound examination of latent small lesions, resection of lesions visible under ultrasound, and then a full breast exploration, one finger page incision interval.Radially cut from the base to the subcutaneous, lesions were found and treated locally. After removal of lesion, fully using the syringe, in turn, use of 3% hydrogen peroxide solution, 1% eniodine, saline water is widely jet pulse washing, and around the lesions base. After rinsing, soak in 1% active iodine for 10min, then rinse with normal saline until the liquid is clear. Breast tumor Surgery (Oncoplastic Breast Surgery, OBS) core technology (volume replacement and volume replacement).

Primary outcomes

  1. Recurrence rate

    Time frame: Up to 2 years

    Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast within one year after surgery was defined as recurrence.

Secondary outcomes

  1. Breast appearance and cosmetic effect score

    Time frame: Up to 2 years

    Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.

  2. Surgical incision healing time

    Time frame: Up to 2 months

    Surgical incision healing time was defined as the time from the first day after the operation to the healing time of the surgical incision. The wound surface was dry, there was no effusion, and no surgical incision complications occurred

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

Randomized Controlled Trial for 'Focus Clearing + Whole Breast Exploration and Washing + One-Stage Micro Plastic Surgery' Treatment for Granulomatous Lobular Mastitis

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Nov 20, 2020
Registry last updated
Nov 20, 2020

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

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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.