Breast-conserving Plastic SurgeryNCT06712524
Effect of Different Surgical Approaches of Granulomatous Mastitis
A study testing Breast-conserving plastic surgery and Traditional breast surgery in people with Breast-conserving Plastic Surgery and Granulomatous Mastitis, run by Hubei Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast-conserving Plastic Surgery, Granulomatous Mastitis
- What is being tested?
- Breast-conserving plastic surgery and Traditional breast surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430060
Xinhong Wu, Doctor, 15902736236, wuxinhong_9@sina.com
Xinjun Liang, Doctor
About this study
Official title: A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome 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.
Read the 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.
- Being tested
- Breast-conserving plastic surgery, Traditional breast surgery
- Keywords
- Granulomatous mastitis, breast conserving plastic surgery, Aesthetics scores
- Medical subject headings
- Granulomatous Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast-conserving plastic surgeryProcedure or surgery
The commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on.
Traditional breast surgeryProcedure or surgery
Traditional breast surgery
| Study group | Role | What they receive |
|---|---|---|
| Breast-conserving plastic surgery group | Experimental | Breast-conserving plastic surgery Receives: Procedure: Breast-conserving plastic surgery |
| Traditional breast surgery group | Active comparator | Traditional breast surgery Receives: Procedure: Traditional breast surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.
Measured: 2, 3, 5 year
Secondary 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.
Measured: 2, 3, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast-conserving Plastic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongmei Zheng, PhD, Hubei Cancer Hospital
- Investigators
- Xinhong Wu, Doctor, Study chair, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712524
- Sponsor's protocol ID
- LLHBCH2024YN-093
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information was protected according to the privacy requirements of our unit.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis
- ClinicalTrials.gov ID
- NCT06712524
- Acronym / sponsor ID
- LLHBCH2024YN-093
- Keywords
- Granulomatous mastitis, breast conserving plastic surgery, Aesthetics scores
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast-conserving plastic surgery group | Experimental | Procedure: Breast-conserving plastic surgeryBreast-conserving plastic surgery |
| Traditional breast surgery group | Active comparator | Procedure: Traditional breast surgeryTraditional breast surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast-conserving plastic surgeryThe commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on. | Procedure or surgery | Breast-conserving plastic surgery group |
| Traditional breast surgeryTraditional breast surgery | Procedure or surgery | Traditional breast surgery group |
Primary outcome
Recurrence rate
Time frame: 2, 3, 5 year
The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.
1 secondary outcome
Aesthetics scores
Time frame: 2, 3, 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No. Patient information was protected according to the privacy requirements of our unit.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinhong Wu, Doctor study chair
Hubei Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast-conserving plastic surgery and Traditional breast surgery in people with Breast-conserving Plastic Surgery and Granulomatous Mastitis, run by Hubei Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongmei Zheng, Doctor (18971624606, zhenghongmeicj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 2, 3, 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.