Breast/SurgeryNCT05560633
Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
An observational study of Breast/Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon. 2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported. 3. The complication rates of the flap and oncological safety were studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast/Surgery
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The eligibility of patients for free-TRAM/DIEP was based on the judgement of surgeons, preference of patients, and guideline recommendation as a standard-of-care. For NSM, patients should receive standard-of-care physical examination, ultrasound, mammogram and/or MRI assessment of the involved breast. Patients with clinical involvement of the nipple areola complex (NAC) were excluded
Who may be able to join
- Female breast cancer patients with age > 18 years
- Received autologous abdominal free-flap breast reconstruction (including muscle-sparing free TRAM or DIEP)
Who cannot join
- Breast conserving patient
- Implant-based breast reconstruction
About this study
Official title: The Feasibility of Nipple-sparing Mastectomy in Combined With Abdominal Free Flap Breast Reconstruction Without Skin Paddles for Flap Monitoring: a Single-center Experience
- Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon.
- Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported.
- The complication rates of the flap and oncological safety were studied.
Read the detailed description
Operative time and complication rate are employed to analysis the learning curve of the ms-Tram and DIEP surgery,which is meaningful for the new microsurgeon training.
Buried flap without the implatable doppler is very common condition all over the world, and the complication rate was evaluated as evidence of reliable of the validated monitoring protocol.
Complication rates were considered as different before and after the platue of the learning curve. Within the study of the learning curve, complication rates were reported.
- Conditions
- Breast/Surgery
- Being tested
- No intervention
- Keywords
- breast cancer, DIEP, ms-TRAM, breast reconstruction, learning curve, nipple spring mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Total flap failure rate
The rate of ms-tram and diep flap were removed from the patients
Measured: Through study completion， and average of 2.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 May 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast/SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560633
- Sponsor's protocol ID
- SYSEC-KY-KS-2021-144
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li S, Zhang S, Zhang X, Yan J, Wang S, Tan L, Rao N, Chen K, Zhu L. The learning curve of the MS-TRAM/DIEP breast reconstruction by dual-trained breast surgeons. BMC Surg. 2024 Feb 14;24(1):53. doi: 10.1186/s12893-024-02344-z.
PubMed 38355459
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Nipple-sparing Mastectomy in Combined With Abdominal Free Flap Breast Reconstruction Without Skin Paddles for Flap Monitoring: a Single-center Experience
- ClinicalTrials.gov ID
- NCT05560633
- Acronym / sponsor ID
- SYSEC-KY-KS-2021-144
- Conditions
- Breast/Surgery
- Keywords
- breast cancer, DIEP, ms-TRAM, breast reconstruction, learning curve, nipple spring mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Sep 2022 (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.
- Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon.
- Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported.
- The complication rates of the flap and oncological safety were studied.
Detailed description
Operative time and complication rate are employed to analysis the learning curve of the ms-Tram and DIEP surgery,which is meaningful for the new microsurgeon training.
Buried flap without the implatable doppler is very common condition all over the world, and the complication rate was evaluated as evidence of reliable of the validated monitoring protocol.
Complication rates were considered as different before and after the platue of the learning curve. Within the study of the learning curve, complication rates were reported.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The eligibility of patients for free-TRAM/DIEP was based on the judgement of surgeons, preference of patients, and guideline recommendation as a standard-of-care. For NSM, patients should receive standard-of-care physical examination, ultrasound, mammogram and/or MRI assessment of the involved breast. Patients with clinical involvement of the nipple areola complex (NAC) were excluded
Key inclusion criteria (2 listed)
- Female breast cancer patients with age > 18 years
- Received autologous abdominal free-flap breast reconstruction (including muscle-sparing free TRAM or DIEP)
Key exclusion criteria (2 listed)
- Breast conserving patient
- Implant-based breast reconstruction
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Total flap failure rate
Time frame: Through study completion， and average of 2.5 year
The rate of ms-tram and diep flap were removed from the patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Derived from this study: PubMed 38355459Li S, Zhang S, Zhang X, Yan J, Wang S, Tan L, Rao N, Chen K, Zhu L. The learning curve of the MS-TRAM/DIEP breast reconstruction by dual-trained breast surgeons. BMC Surg. 2024 Feb 14;24(1):53. doi: 10.1186/s12893-024-02344-z.
- Individual participant dataSharing planned: Undecided
Related trials for Breast/Surgery
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast/Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total flap failure rate (time frame: Through study completion， and average of 2.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560633, which also lists 1 linked publication.
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 29 Sep 2022.