MammaplastyNCT00514748
A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction
A study testing DIEP and Interconnected DIEP in people with Mammaplasty, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one vessel pedicle and observe its survival in… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mammaplasty
- What is being tested?
- DIEP and Interconnected DIEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Jan 2007to May 2009
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast lost after mastectomy
- With good general condition
- No pregnancy demand
- With additional soft tissue needed for reconstruction
Who cannot join
- With bad general condition
- DIEA damaged by previous surgery
- Limited abdominal tissue
Trial locations and contacts
1 site in 1 country.
About this study
Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one vessel pedicle and observe its survival in breast reconstruction.
Read the detailed description
The DIEP flap have become the most common and primary choice in autogenous tissue breast reconstruction nowadays. In cases with inadequate abdominal soft-tissue volume or abdominal midline scar, the bilateral DIEP flap is needed.However, it need two groups of recipient vessels. So it is unavailable in cases short of two groups of recipient vessels after radiotherapy. This study is aimed to solve the problems by interconnecting one of the branches of DIEA each side. The MDCT will be used to predict the branches and perforators of DIEA both sides. According to the branches of DIEAs, one branch will be anastomosed with that on contralateral side with only one vessel pedicle preserved on one side. We believe that the whole flap can be completely nourished with only one vessel pedicle by means of vessel interconnection.
- Conditions
- Mammaplasty
- Being tested
- DIEP, Interconnected DIEP
- Keywords
- breast reconstruction, DIEP, vessel pedicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIEPProcedure or surgery
flap survival, operation time, flap complications, donor site morbidity.
Interconnected DIEPProcedure or surgery
flap survival, operation time, flap complications, donor site morbidity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients who receive breast reconstruction with bilateral DIEP flap based on bilateral vessel pedicles Receives: Procedure: DIEP |
| 2 | Experimental | Patient who receive breast reconstruction with vessel interconnected DIEP flap based on one vessel pedicle Receives: Procedure: Interconnected DIEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the whole flap may survived on the single vessel pedicle.
Measured: more than one year after srugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MammaplastyStudies 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)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Investigators
- Jie Luan, MD, Study chair, Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514748
- Sponsor's protocol ID
- 621125-2
- Status last verified
- Jun 2009
- First submitted
- 9 Aug 2007
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bains RD, Stanley PR, Riaz M. Avoiding donor-site complications with bilateral DIEP flaps in patients with subcostal scars. Plast Reconstr Surg. 2007 Jun;119(7):2337-2339. doi: 10.1097/01.prs.0000261064.22785.74. No abstract available.
PubMed 17519766Bains RD, Riaz M, Stanley P. Bilateral free DIEP breast reconstruction using contralateral internal mammary and ipsilateral thoracodorsal vessels. Plast Reconstr Surg. 2007 Apr 1;119(4):1385-1386. doi: 10.1097/01.prs.0000255180.17788.8c. No abstract available.
PubMed 17496625Lasso JM, Sancho M, Campo V, Jimenez E, Perez Cano R. Epiperitoneal vessels: more resources to perform DIEP flaps. J Plast Reconstr Aesthet Surg. 2008 Jul;61(7):826-9. doi: 10.1016/j.bjps.2007.03.004. Epub 2007 Apr 18.
PubMed 17446150Schoeller T, Wechselberger G, Roger J, Hussl H, Huemer GM. Management of infraumbilical vertical scars in DIEP-flaps by crossover anastomosis. J Plast Reconstr Aesthet Surg. 2007;60(5):524-8. doi: 10.1016/j.bjps.2006.11.008. Epub 2007 Jan 22.
PubMed 17399662Das-Gupta R, Busic V, Begic A. Deep inferior epigastric perforator flap (DIEP) breast reconstruction in the presence of a midline vertical scar. J Plast Reconstr Aesthet Surg. 2006;59(6):675-6. doi: 10.1016/j.bjps.2005.07.003. No abstract available.
PubMed 16817262Holm C, Mayr M, Hofter E, Ninkovic M. Perfusion zones of the DIEP flap revisited: a clinical study. Plast Reconstr Surg. 2006 Jan;117(1):37-43. doi: 10.1097/01.prs.0000185867.84172.c0.
PubMed 16404245Gill PS, Hunt JP, Guerra AB, Dellacroce FJ, Sullivan SK, Boraski J, Metzinger SE, Dupin CL, Allen RJ. A 10-year retrospective review of 758 DIEP flaps for breast reconstruction. Plast Reconstr Surg. 2004 Apr 1;113(4):1153-60. doi: 10.1097/01.prs.0000110328.47206.50.
PubMed 15083015Garcia-Tutor E, Murillo J. The ideal patient for the first breast reconstruction using a diep flap. Plast Reconstr Surg. 2003 Feb;111(2):947-8. doi: 10.1097/00006534-200302000-00087. No abstract available.
PubMed 12560733Vesely J, Stupka I, Drazan L, Holusa P, Licata P, Corradini B. DIEP flap breast reconstruction--new experience. Acta Chir Plast. 2001;43(1):3-6.
PubMed 11370256Tran NV, Buchel EW, Convery PA. Microvascular complications of DIEP flaps. Plast Reconstr Surg. 2007 Apr 15;119(5):1397-1405. doi: 10.1097/01.prs.0000256045.71765.96.
PubMed 17415232Blondeel PN. One hundred free DIEP flap breast reconstructions: a personal experience. Br J Plast Surg. 1999 Mar;52(2):104-11. doi: 10.1054/bjps.1998.3033.
PubMed 10434888
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT00514748
- Acronym / sponsor ID
- 621125-2
- Conditions
- Mammaplasty
- Keywords
- breast reconstruction, DIEP, vessel pedicle
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Aug 2007 (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.
Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one vessel pedicle and observe its survival in breast reconstruction.
Detailed description
The DIEP flap have become the most common and primary choice in autogenous tissue breast reconstruction nowadays. In cases with inadequate abdominal soft-tissue volume or abdominal midline scar, the bilateral DIEP flap is needed.However, it need two groups of recipient vessels. So it is unavailable in cases short of two groups of recipient vessels after radiotherapy. This study is aimed to solve the problems by interconnecting one of the branches of DIEA each side. The MDCT will be used to predict the branches and perforators of DIEA both sides. According to the branches of DIEAs, one branch will be anastomosed with that on contralateral side with only one vessel pedicle preserved on one side. We believe that the whole flap can be completely nourished with only one vessel pedicle by means of vessel interconnection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: DIEPPatients who receive breast reconstruction with bilateral DIEP flap based on bilateral vessel pedicles |
| 2 | Experimental | Procedure: Interconnected DIEPPatient who receive breast reconstruction with vessel interconnected DIEP flap based on one vessel pedicle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast lost after mastectomy
- With good general condition
- No pregnancy demand
- With additional soft tissue needed for reconstruction
Key exclusion criteria (3 listed)
- With bad general condition
- DIEA damaged by previous surgery
- Limited abdominal tissue
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 |
|---|---|---|
| DIEPflap survival, operation time, flap complications, donor site morbidity. | Procedure or surgery | 1 |
| Interconnected DIEPflap survival, operation time, flap complications, donor site morbidity. | Procedure or surgery | 2 |
Primary outcome
the whole flap may survived on the single vessel pedicle.
Time frame: more than one year after srugery
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 24 Jun 2009.
- Background: PubMed 17519766Bains RD, Stanley PR, Riaz M. Avoiding donor-site complications with bilateral DIEP flaps in patients with subcostal scars. Plast Reconstr Surg. 2007 Jun;119(7):2337-2339. doi: 10.1097/01.prs.0000261064.22785.74. No abstract available.
- Background: PubMed 17496625Bains RD, Riaz M, Stanley P. Bilateral free DIEP breast reconstruction using contralateral internal mammary and ipsilateral thoracodorsal vessels. Plast Reconstr Surg. 2007 Apr 1;119(4):1385-1386. doi: 10.1097/01.prs.0000255180.17788.8c. No abstract available.
- Background: PubMed 17446150Lasso JM, Sancho M, Campo V, Jimenez E, Perez Cano R. Epiperitoneal vessels: more resources to perform DIEP flaps. J Plast Reconstr Aesthet Surg. 2008 Jul;61(7):826-9. doi: 10.1016/j.bjps.2007.03.004. Epub 2007 Apr 18.
- Background: PubMed 17399662Schoeller T, Wechselberger G, Roger J, Hussl H, Huemer GM. Management of infraumbilical vertical scars in DIEP-flaps by crossover anastomosis. J Plast Reconstr Aesthet Surg. 2007;60(5):524-8. doi: 10.1016/j.bjps.2006.11.008. Epub 2007 Jan 22.
- Background: PubMed 16817262Das-Gupta R, Busic V, Begic A. Deep inferior epigastric perforator flap (DIEP) breast reconstruction in the presence of a midline vertical scar. J Plast Reconstr Aesthet Surg. 2006;59(6):675-6. doi: 10.1016/j.bjps.2005.07.003. No abstract available.
- Background: PubMed 16404245Holm C, Mayr M, Hofter E, Ninkovic M. Perfusion zones of the DIEP flap revisited: a clinical study. Plast Reconstr Surg. 2006 Jan;117(1):37-43. doi: 10.1097/01.prs.0000185867.84172.c0.
- Background: PubMed 15083015Gill PS, Hunt JP, Guerra AB, Dellacroce FJ, Sullivan SK, Boraski J, Metzinger SE, Dupin CL, Allen RJ. A 10-year retrospective review of 758 DIEP flaps for breast reconstruction. Plast Reconstr Surg. 2004 Apr 1;113(4):1153-60. doi: 10.1097/01.prs.0000110328.47206.50.
- Background: PubMed 12560733Garcia-Tutor E, Murillo J. The ideal patient for the first breast reconstruction using a diep flap. Plast Reconstr Surg. 2003 Feb;111(2):947-8. doi: 10.1097/00006534-200302000-00087. No abstract available.
- Background: PubMed 11370256Vesely J, Stupka I, Drazan L, Holusa P, Licata P, Corradini B. DIEP flap breast reconstruction--new experience. Acta Chir Plast. 2001;43(1):3-6.
- Background: PubMed 17415232Tran NV, Buchel EW, Convery PA. Microvascular complications of DIEP flaps. Plast Reconstr Surg. 2007 Apr 15;119(5):1397-1405. doi: 10.1097/01.prs.0000256045.71765.96.
- Background: PubMed 10434888Blondeel PN. One hundred free DIEP flap breast reconstructions: a personal experience. Br J Plast Surg. 1999 Mar;52(2):104-11. doi: 10.1054/bjps.1998.3033.
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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.
Jie Luan, MD study chair
Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIEP and Interconnected DIEP in people with Mammaplasty, run by Chinese Academy of Sciences 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 4 inclusion and 3 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 24 Jun 2009. 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?
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?
the whole flap may survived on the single vessel pedicle. (time frame: more than one year after srugery). 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 NCT00514748, which also lists 11 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 24 Jun 2009.