Effect of Different Surgical Approaches of Granulomatous Mastitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHubei Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Breast-conserving plastic surgery
Procedure/SurgeryThe commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on.
Traditional breast surgery
Procedure/SurgeryTraditional breast surgery
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Breast-conserving plastic surgery groupExperimental treatment 1 intervention
Group B: Traditional breast surgery groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence rate
The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.
Time frame
2, 3, 5 yearSecondary outcomes
1
Aesthetics scores
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.
Time frame
2, 3, 5 yearSponsors and contacts
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Source ClinicalTrials.gov