Neoplasm of Female BreastNCT02452333
Oncoplastic Approach to Excisional Breast Biopsies
A study testing Oncoplastic Approach Excisional Breast Biopsy, Conventional Excisional Breast Biopsy and Tezel Method of Breast Volume Measurement in people with Neoplasm of Female Breast and Breast Neoplasms Diagnosis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasm of Female Breast, Breast Neoplasms Diagnosis, Breast Diseases
- What is being tested?
- Oncoplastic Approach Excisional Breast Biopsy, Conventional Excisional Breast Biopsy and Tezel Method of Breast Volume Measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2015to Jul 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are decided to be suitable for excisional breast biopsy.
- Nonpalpable breast lesions suspicious for malignancy where less-invasive approach like fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy can not provide sufficient diagnostic efficiency for the diagnosis.
- Palpable breast lesions when a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols.
Who cannot join
- Patients who are decided to be suitable for mastectomy included protocols as the primary surgery.
- Patients who have previously had breast surgery.
- Patients who refused excisional breast biopsy.
- Patients who do not want to be photographed for cosmetic evaluations.
- Patients diagnosed with secondary suspicious breast lesions necessitating surgical intervention during the follow-up period.
- Presence of probable multicentric lesions.
Show all 9Show fewer
- Refusal of the patient to participate in the study for any reason.
- Aberrations in the normal development and involution of the breast
- Injury or trauma history of the breast resulted in deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncoplastic Approach to Excisional Breast Biopsies: A Prospective Randomized Controlled Trial
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.
Read the detailed description
Excisional breast biopsy is one of the routine surgical interventions in general surgery clinics, implemented for clinical diagnosis of suspicious breast lesions. It is the diagnostic method of choice especially when fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy as part of a non-invasive approach can not provide sufficient diagnostic efficiency for the diagnosis of non-palpable breast lesions. This invasive biopsy approach must be selectively tailored according to the nature of the lesion, either directly or as a second-stage procedure, necessarily, if a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols. By definition, basic difference from a segmental mastectomy or a lumpectomy is that excisional breast biopsy is a surgical procedure to remove suspicious breast tissue and a small amount of normal tissue around it only before the pathologic diagnosis is confirmed.
Prebiopsy localisation modalities like wire-guidance or radioisotope occult lesion localization (ROLL) are proven to reduce the rates of margin positivity at initial lumpectomies in breast cancer. Accomplishing the excision as a whole with a 1 cm layer of normal tissue around by means of an incision confined to possible mastectomy line, whilst preserving the skin if it is 1cm far away from the suspicious area and a three-dimensional marking on the specimen are considered to be general principles in conventional excisional breast biopsies. In the same way, another ground rule would be close collaboration with plastic and reconstructive surgery department, especially when significant relative breast volume loss is anticipated and defect should be restored using volume replacement methods or when the nipple and areola complex (NAC) is under threat. It is imperative that the patient be informed of the common risks and reasonable alternatives to the proposed treatment. For patients seeking additional advice on NAC disturbances it is important to keep in mind that the tattoo art might be an appealing suggestion; many consider tattooing as a practical complementary solution for sequela after reconstruction of Nipple-areolar complex.
On the other hand, in the vast majority of the cases the mainstay of treatment does not entail surgical resection of NAC or requisite volume replacement, but still there is debate as to whether surgeons should place parenchymal sutures to approximate the cut edges of the cavity walls. The rationale behind this debate is that closure of the tissue defect with direct suture approximation brings about a considerable heterogeneity when it comes to cosmetic parameters. Besides, in many cases, when not coupled with overlying skin dissection after probable dimples observed on the skin while knotting each suture, this modality is ended up too far off target to merit the highest degree of patient satisfaction. Fortunately, surgical algorithms for breast tumors have been refined a great deal in recent years with rapid developments and key technique definitions in the field of oncoplastic surgery and opinions favoring parenchymal sutures have been strengthened.
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.
- Conditions
- Neoplasm of Female Breast, Breast Neoplasms Diagnosis, Breast Diseases, Deformity of Reconstructed Breast
- Being tested
- Oncoplastic Approach Excisional Breast Biopsy, Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement, Cosmetic Assessment
- Keywords
- Excisional breast biopsy, Oncoplastic surgery, Oncoplastic reconstruction, Breast conserving surgery, Tezel method of breast volume measurement
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncoplastic Approach Excisional Breast BiopsyProcedure or surgery
Evidence based quadrant by quadrant oncoplastic algorithm reinforced with videoscopic applications for peripheral lesions.
Conventional Excisional Breast BiopsyProcedure or surgery
Conventional Excisional Breast Biopsy
Tezel Method of Breast Volume MeasurementOther
Tezel Method is a simple, accurate and non-invasive method of measuring differences in breast volume based on Archimedes' principle
Cosmetic AssessmentOther
Cosmetic Assessment with Harris scale graded by patient, surgeon and professional third party. A standardised photograph of front, side and mediolateral oblique views will be taken using a digital camera for professional third party observers.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based Oncoplastic Algorithm | Experimental | Oncoplastic Approach Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment Receives: Procedure: Oncoplastic Approach Excisional Breast Biopsy; Other: Tezel Method of Breast Volume Measurement; Other: Cosmetic Assessment |
| Control | Experimental | - Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment Receives: Procedure: Conventional Excisional Breast Biopsy; Other: Tezel Method of Breast Volume Measurement; Other: Cosmetic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris scale for the cosmetic result.
Patient, surgeon and professional third party observers rate cosmetic results (in terms of color, symmetry, contour and general cosmetic outcome) on a four-point scale:
(4) excellent-treated breast nearly identical to untreated breast; (3) good-treated breast slightly different from untreated; (2) fair-treated breast clearly different from untreated but not seriously distorted; (1) poor- treated breast seriously distorted.
Measured: 3 months
Secondary outcomes (8)
Surgical margin positivity for malignancy
Ultimate histopathologic diagnosis
Measured: Approximately 2 weeks
Radiologic assessment of surgical margins
Specimen mammography: Applicable to mammographically depicted lesions only
Measured: Intraoperatively assessed
Morbidity
Bleeding, hematoma, seroma, necrosis or infection after surgery.
Measured: 3 months
Reoperations
Need for any reoperations whether morbidity or surgical margins related.
Measured: 3 months
Breast Size
Unilateral breast volume measured with Tezel method to discriminate small (250 cc and less) vs. medium/large (>250 cc) breasts; determine oncoplastic intervention level (I or II) after assessment of anticipated volume ratio of the resection specimen.
Measured: Preoperatively assessed
Lesion Peripherality
Lesion peripherality along with the videoscopic application preference is decided after assessment of areolar diameter, distance between areolar margin and the skin projection of the central spot of the lesion together with the depth of the lesion; all of which are determinants for ease of access to resection area.
Measured: Preoperatively assessed
Anticipated specimen volume
Preoperatively anticipated specimen volume according to radiologic investigation.
Measured: Preoperatively assessed
Exact specimen volume
True volume of the excised breast tissue
Measured: Intraoperatively assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neoplasm of Female BreastStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cumhur Arıcı, Professor, Study director, Akdeniz University, General Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452333
- Sponsor's protocol ID
- 70904504
- Status last verified
- Feb 2019
- First submitted
- 18 May 2015
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Santos G, Urban C, Edelweiss MI, Zucca-Matthes G, de Oliveira VM, Arana GH, Iera M, Rietjens M, de Lima RS, Spautz C, Kuroda F, Anselmi K, Capp E. Long-Term Comparison of Aesthetical Outcomes After Oncoplastic Surgery and Lumpectomy in Breast Cancer Patients. Ann Surg Oncol. 2015 Aug;22(8):2500-8. doi: 10.1245/s10434-014-4301-6. Epub 2014 Dec 18.
PubMed 25519931McCulley SJ, Macmillan RD. Planning and use of therapeutic mammoplasty--Nottingham approach. Br J Plast Surg. 2005 Oct;58(7):889-901. doi: 10.1016/j.bjps.2005.03.008.
PubMed 16043150Clough KB, Ihrai T, Oden S, Kaufman G, Massey E, Nos C. Oncoplastic surgery for breast cancer based on tumour location and a quadrant-per-quadrant atlas. Br J Surg. 2012 Oct;99(10):1389-95. doi: 10.1002/bjs.8877.
PubMed 22961518Cardoso MJ, Cardoso JS, Wild T, Krois W, Fitzal F. Comparing two objective methods for the aesthetic evaluation of breast cancer conservative treatment. Breast Cancer Res Treat. 2009 Jul;116(1):149-52. doi: 10.1007/s10549-008-0173-4. Epub 2008 Sep 7.
PubMed 18777134Yamashita K, Shimizu K. Transaxillary retromammary route approach of video-assisted breast surgery enables the inner-side breast cancer to be resected for breast conserving surgery. Am J Surg. 2008 Oct;196(4):578-81. doi: 10.1016/j.amjsurg.2008.06.028.
PubMed 18809067Serra-Renom JM, Serra-Mestre JM, Martinez L, D'Andrea F. Endoscopic reconstruction of partial mastectomy defects using latissimus dorsi muscle flap without causing scars on the back. Aesthetic Plast Surg. 2013 Oct;37(5):941-9. doi: 10.1007/s00266-013-0192-3. Epub 2013 Jul 23.
PubMed 23877754Tezel E, Numanoglu A. Practical do-it-yourself device for accurate volume measurement of breast. Plast Reconstr Surg. 2000 Mar;105(3):1019-23. doi: 10.1097/00006534-200003000-00028.
PubMed 10724264Nakajima H, Fujiwara I, Mizuta N, Sakaguchi K, Hachimine Y, Magae J. Video-assisted skin-sparing breast-conserving surgery for breast cancer and immediate reconstruction with autologous tissue: clinical outcomes. Ann Surg Oncol. 2009 Jul;16(7):1982-9. doi: 10.1245/s10434-009-0429-1. Epub 2009 Apr 24.
PubMed 19390899Nakajima H, Fujiwara I, Mizuta N, Sakaguchi K, Hachimine Y. Video-assisted skin-sparing breast-conserving surgery for breast cancer and immediate reconstruction with autologous tissue. Ann Surg. 2009 Jan;249(1):91-6. doi: 10.1097/SLA.0b013e31818e3fa6.
PubMed 19106682Zaha H. Partial breast reconstruction for the medial quadrants using the omental flap. Ann Surg Oncol. 2014 Oct;21(10):3358. doi: 10.1245/s10434-014-3907-z. Epub 2014 Jul 26.
PubMed 25063006
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncoplastic Approach to Excisional Breast Biopsies: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02452333
- Acronym / sponsor ID
- 70904504
- Conditions
- Neoplasm of Female Breast, Breast Neoplasms Diagnosis, Breast Diseases, Deformity of Reconstructed Breast
- Keywords
- Excisional breast biopsy, Oncoplastic surgery, Oncoplastic reconstruction, Breast conserving surgery, Tezel method of breast volume measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 May 2015 (estimated)
- 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.
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.
Detailed description
Excisional breast biopsy is one of the routine surgical interventions in general surgery clinics, implemented for clinical diagnosis of suspicious breast lesions. It is the diagnostic method of choice especially when fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy as part of a non-invasive approach can not provide sufficient diagnostic efficiency for the diagnosis of non-palpable breast lesions. This invasive biopsy approach must be selectively tailored according to the nature of the lesion, either directly or as a second-stage procedure, necessarily, if a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols. By definition, basic difference from a segmental mastectomy or a lumpectomy is that excisional breast biopsy is a surgical procedure to remove suspicious breast tissue and a small amount of normal tissue around it only before the pathologic diagnosis is confirmed.
Prebiopsy localisation modalities like wire-guidance or radioisotope occult lesion localization (ROLL) are proven to reduce the rates of margin positivity at initial lumpectomies in breast cancer. Accomplishing the excision as a whole with a 1 cm layer of normal tissue around by means of an incision confined to possible mastectomy line, whilst preserving the skin if it is 1cm far away from the suspicious area and a three-dimensional marking on the specimen are considered to be general principles in conventional excisional breast biopsies. In the same way, another ground rule would be close collaboration with plastic and reconstructive surgery department, especially when significant relative breast volume loss is anticipated and defect should be restored using volume replacement methods or when the nipple and areola complex (NAC) is under threat. It is imperative that the patient be informed of the common risks and reasonable alternatives to the proposed treatment. For patients seeking additional advice on NAC disturbances it is important to keep in mind that the tattoo art might be an appealing suggestion; many consider tattooing as a practical complementary solution for sequela after reconstruction of Nipple-areolar complex.
On the other hand, in the vast majority of the cases the mainstay of treatment does not entail surgical resection of NAC or requisite volume replacement, but still there is debate as to whether surgeons should place parenchymal sutures to approximate the cut edges of the cavity walls. The rationale behind this debate is that closure of the tissue defect with direct suture approximation brings about a considerable heterogeneity when it comes to cosmetic parameters. Besides, in many cases, when not coupled with overlying skin dissection after probable dimples observed on the skin while knotting each suture, this modality is ended up too far off target to merit the highest degree of patient satisfaction. Fortunately, surgical algorithms for breast tumors have been refined a great deal in recent years with rapid developments and key technique definitions in the field of oncoplastic surgery and opinions favoring parenchymal sutures have been strengthened.
Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-based Oncoplastic Algorithm | Experimental | Procedure: Oncoplastic Approach Excisional Breast Biopsy, Other: Tezel Method of Breast Volume Measurement, Other: Cosmetic AssessmentOncoplastic Approach Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment |
| Control | Experimental | Procedure: Conventional Excisional Breast Biopsy, Other: Tezel Method of Breast Volume Measurement, Other: Cosmetic Assessment- Conventional Excisional Breast Biopsy, Tezel Method of Breast Volume Measurement and Cosmetic Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are decided to be suitable for excisional breast biopsy.
- Nonpalpable breast lesions suspicious for malignancy where less-invasive approach like fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or vacuum-assisted core biopsy can not provide sufficient diagnostic efficiency for the diagnosis.
- Palpable breast lesions when a sufficiently precise diagnosis cannot be reached after practicing less-invasive protocols.
Key exclusion criteria (9 listed)
- Patients who are decided to be suitable for mastectomy included protocols as the primary surgery.
- Patients who have previously had breast surgery.
- Patients who refused excisional breast biopsy.
- Patients who do not want to be photographed for cosmetic evaluations.
- Patients diagnosed with secondary suspicious breast lesions necessitating surgical intervention during the follow-up period.
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 |
|---|---|---|
| Oncoplastic Approach Excisional Breast BiopsyEvidence based quadrant by quadrant oncoplastic algorithm reinforced with videoscopic applications for peripheral lesions. | Procedure or surgery | Evidence-based Oncoplastic Algorithm |
| Conventional Excisional Breast BiopsyConventional Excisional Breast Biopsy | Procedure or surgery | Control |
| Tezel Method of Breast Volume MeasurementTezel Method is a simple, accurate and non-invasive method of measuring differences in breast volume based on Archimedes' principle | Other | Control, Evidence-based Oncoplastic Algorithm |
| Cosmetic AssessmentCosmetic Assessment with Harris scale graded by patient, surgeon and professional third party. A standardised photograph of front, side and mediolateral oblique views will be taken using a digital camera for professional third party observers. | Other | Control, Evidence-based Oncoplastic Algorithm |
Primary outcome
Harris scale for the cosmetic result.
Time frame: 3 months
Patient, surgeon and professional third party observers rate cosmetic results (in terms of color, symmetry, contour and general cosmetic outcome) on a four-point scale: (4) excellent-treated breast nearly identical to untreated breast; (3) good-treated breast slightly different from untreated; (2) fair-treated breast clearly different from untreated but not seriously distorted; (1) poor- treated breast seriously distorted.
8 secondary outcomes
Surgical margin positivity for malignancy
Time frame: Approximately 2 weeks
Radiologic assessment of surgical margins
Time frame: Intraoperatively assessed
Morbidity
Time frame: 3 months
Reoperations
Time frame: 3 months
Breast Size
Time frame: Preoperatively assessed
Lesion Peripherality
Time frame: Preoperatively assessed
Anticipated specimen volume
Time frame: Preoperatively assessed
Exact specimen volume
Time frame: Intraoperatively assessed
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 28 Feb 2019.
- Background: PubMed 25519931Santos G, Urban C, Edelweiss MI, Zucca-Matthes G, de Oliveira VM, Arana GH, Iera M, Rietjens M, de Lima RS, Spautz C, Kuroda F, Anselmi K, Capp E. Long-Term Comparison of Aesthetical Outcomes After Oncoplastic Surgery and Lumpectomy in Breast Cancer Patients. Ann Surg Oncol. 2015 Aug;22(8):2500-8. doi: 10.1245/s10434-014-4301-6. Epub 2014 Dec 18.
- Background: PubMed 16043150McCulley SJ, Macmillan RD. Planning and use of therapeutic mammoplasty--Nottingham approach. Br J Plast Surg. 2005 Oct;58(7):889-901. doi: 10.1016/j.bjps.2005.03.008.
- Background: PubMed 22961518Clough KB, Ihrai T, Oden S, Kaufman G, Massey E, Nos C. Oncoplastic surgery for breast cancer based on tumour location and a quadrant-per-quadrant atlas. Br J Surg. 2012 Oct;99(10):1389-95. doi: 10.1002/bjs.8877.
- Background: PubMed 18777134Cardoso MJ, Cardoso JS, Wild T, Krois W, Fitzal F. Comparing two objective methods for the aesthetic evaluation of breast cancer conservative treatment. Breast Cancer Res Treat. 2009 Jul;116(1):149-52. doi: 10.1007/s10549-008-0173-4. Epub 2008 Sep 7.
- Background: PubMed 18809067Yamashita K, Shimizu K. Transaxillary retromammary route approach of video-assisted breast surgery enables the inner-side breast cancer to be resected for breast conserving surgery. Am J Surg. 2008 Oct;196(4):578-81. doi: 10.1016/j.amjsurg.2008.06.028.
- Background: PubMed 23877754Serra-Renom JM, Serra-Mestre JM, Martinez L, D'Andrea F. Endoscopic reconstruction of partial mastectomy defects using latissimus dorsi muscle flap without causing scars on the back. Aesthetic Plast Surg. 2013 Oct;37(5):941-9. doi: 10.1007/s00266-013-0192-3. Epub 2013 Jul 23.
- Background: PubMed 10724264Tezel E, Numanoglu A. Practical do-it-yourself device for accurate volume measurement of breast. Plast Reconstr Surg. 2000 Mar;105(3):1019-23. doi: 10.1097/00006534-200003000-00028.
- Background: PubMed 19390899Nakajima H, Fujiwara I, Mizuta N, Sakaguchi K, Hachimine Y, Magae J. Video-assisted skin-sparing breast-conserving surgery for breast cancer and immediate reconstruction with autologous tissue: clinical outcomes. Ann Surg Oncol. 2009 Jul;16(7):1982-9. doi: 10.1245/s10434-009-0429-1. Epub 2009 Apr 24.
- Background: PubMed 19106682Nakajima H, Fujiwara I, Mizuta N, Sakaguchi K, Hachimine Y. Video-assisted skin-sparing breast-conserving surgery for breast cancer and immediate reconstruction with autologous tissue. Ann Surg. 2009 Jan;249(1):91-6. doi: 10.1097/SLA.0b013e31818e3fa6.
- Background: PubMed 25063006Zaha H. Partial breast reconstruction for the medial quadrants using the omental flap. Ann Surg Oncol. 2014 Oct;21(10):3358. doi: 10.1245/s10434-014-3907-z. Epub 2014 Jul 26.
- Oncoplastic approach to excisional breast biopsies: a randomized controlled, phase 2a trialLink provided by the sponsor.
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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.
Cumhur Arıcı, Professor study director
Akdeniz University, General Surgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncoplastic Approach Excisional Breast Biopsy, Conventional Excisional Breast Biopsy and Tezel Method of Breast Volume Measurement in people with Neoplasm of Female Breast and Breast Neoplasms Diagnosis, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 28 Feb 2019. 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 Turkey (Türkiye). 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?
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?
Harris scale for the cosmetic result. (time frame: 3 months). 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 NCT02452333, which also lists 10 linked publications.
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 28 Feb 2019.