DIEP Flap Breast Reconstruction(DIEP)NCT07222514
Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest
A study testing Single-Port Robotic System in people with DIEP Flap Breast Reconstruction, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction. The investigators will also investigate complications of the procedure, incision length, flap success rate, post operative pain, vascular pedicle length and caliber, and VMP-B score (quality… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- DIEP Flap Breast Reconstruction
- What is being tested?
- Single-Port Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to Dec 2028
- 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
- Female patients aged ≥18 years.
- Candidates for unilateral or bilateral breast reconstruction using a DIEP flap.
- No contraindications for general anesthesia or robotic surgery.
- Patients with adequate abdominal donor tissue for DIEP flap harvest.
Who cannot join
- History of prior abdominal surgery that significantly compromises perforator vessel integrity.
- Pregnant woman.
- Prisoners.
- BMI > 35, as measured during the preoperative evaluation.
- Presence of comorbidities that contraindicate elective surgery.
- Active cancer other than breast cancer at the time of evaluation.
Show all 9Show fewer
- Active metastatic disease confirmed via imaging or biopsy.
- Inability to comply with follow-up visits.
- The research team decides to exclude the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jun Yao contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Julia Yao, 615-343-8426, jun.yao@vumc.org
About this study
Official title: Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation
The primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction. The investigators will also investigate complications of the procedure, incision length, flap success rate, post operative pain, vascular pedicle length and caliber, and VMP-B score (quality of life/satisfaction of breast procedures survey).
Read the detailed description
This project will be conducted at Vanderbilt University Medical Center. Patients scheduled for a DIEP flap procedure will be recruited through screening of the electronic medical records (EMR) to evaluate eligibility based on pre-established inclusion and exclusion criteria. Eligible patients will be invited to participate in a preoperative consultation, during which they will receive detailed information about the study, including the surgical techniques, potential risks, and benefits. Written informed consent will be obtained from those who agree to participate.
Baseline data available in the medical records as part of their clinical care, including patient demographics, medical history, imaging, pictures, pain and quality-of-life metrics, will also be collected.
On the day of surgery, patients will undergo standard preoperative preparations. The procedure will involve robotic-assisted DIEP flap harvest using single-port access, followed by flap transfer and microsurgical anastomosis. Post-surgical donor site closure will employ techniques to minimize morbidity. Key intraoperative data, such as operative time and complications, will be recorded.
Patient Electronic Medical Records (EMR) will be accessed by research personnel to monitor patients who elect to have the proposed procedure. Postoperative monitoring will focus on flap viability and patient recovery during the hospital stay and subsequent follow-ups. Assessments will include complications, donor site integrity, pain levels, and patient-reported outcomes. Follow-up visits will evaluate both short- and long-term outcomes, including satisfaction and quality of life, providing comprehensive data for the study's primary and secondary aims.
- Conditions
- DIEP Flap Breast Reconstruction
- Being tested
- Single-Port Robotic System
- Keywords
- DIEP flap breast reconstruction, Robotic Surgery, Breast Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Port Robotic SystemDevice
Utilizing the Single-Port robotic system for DIEP flap harvest has been previously described, but only in a small pilot study. The investigators plan to demonstrate the feasibility and safety of this approach on a larger cohort of patients.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Assisted DIEP Breast Reconstruction | Experimental | This group consists of patients receiving the investigative procedure - robotic assisted DIEP flap harvest for breast reconstruction. Receives: Device: Single-Port Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of performing DIEP flap breast construction using a single port robotic system
This will be "Yes" if the following are true of the procedure: completed pedicle dissection using the robotic system, adequate pedicle dissected, and no intraoperative complication requiring conversion to the open approach.
Measured: From enrollment to the end of the procedure.
Secondary outcomes (9)
Complication Rates
Intraoperative and postoperative complications. Including, but not limited to: flap failure, internal structure injuries, deep venous thrombosis, etc.
Measured: Through study completion, an average of 1 year.
Fascial Incision Length
Measurement of the fascial incision length and prevalence of abdominal herniation or bulging through the incision.
Measured: Through study completion, an average of 1 year.
Flap Success Rate
We define flap success rate as survival of the flap without loss of viability through a specified time window.
Measured: From procedure to 7 days post operation.
Operative Time
The time interval between first skin incision to skin closure of the patient.
Measured: From procedure start to procedure completion.
Pain Level
The patient level of pain on a scale of 1 (no pain) to 10 (extreme pain).
Measured: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Length
The pedicle length used for anastomosis will be measured intraoperatively, reported in mm.
Measured: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)
Vanderbilt Mini Patient Reported Outcome - Breast (VMP-B) Score
The investigators will collect patient VMP-B (a validated patient reported outcome) scores to assess patient well being and satisfaction with their procedure. Items (16 total) are scored on a 5-point Likert scale, scores range from 16 (worst) to 80 (best).
Measured: From enrollment to 12 months post operation. Surveys will be distributed preoperatively and at postoperative follow up intervals (2 weeks, 6 weeks, 3 months, 6 months, and 12 months).
Pain Management
The investigators will record what analgesics are used to control patient pain.
Measured: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Caliber
The pedicle caliber used for anastomosis will be measured intraoperatively, reported in mm.
Measured: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start20 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DIEP Flap Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Principal investigator, Galen Perdikis, Vanderbilt University Medical Center
- Investigators
- Galen Perdiks, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222514
- Sponsor's protocol ID
- 250009
- Acronym
- (DIEP)
- Status last verified
- May 2026
- First submitted
- 9 Sep 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: As this is a feasibility study - there is no indication to share individual participant data.
Publications
Roy N, Alessandro CJ, Ibelli TJ, Akhavan AA, Sharaf JM, Rabinovitch D, Henderson PW, Yao A. The Expanding Utility of Robotic-Assisted Flap Harvest in Autologous Breast Reconstruction: A Systematic Review. J Clin Med. 2023 Jul 27;12(15):4951. doi: 10.3390/jcm12154951.
PubMed 37568353Tsai CY, Kim BS, Kuo WL, Liu KH, Chang TN, Cheong DC, Huang JJ. Novel Port Placement in Robot-Assisted DIEP Flap Harvest Improves Visibility and Bilateral DIEP Access: Early Controlled Cohort Study. Plast Reconstr Surg. 2023 Oct 1;152(4):590e-595e. doi: 10.1097/PRS.0000000000010470. Epub 2023 Mar 30.
PubMed 36995211Lee MJ, Won J, Song SY, Park HS, Kim JY, Shin HJ, Kwon YI, Lee DW, Kim NY. Clinical outcomes following robotic versus conventional DIEP flap in breast reconstruction: A retrospective matched study. Front Oncol. 2022 Sep 14;12:989231. doi: 10.3389/fonc.2022.989231. eCollection 2022.
PubMed 36185209Choi JH, Song SY, Park HS, Kim CH, Kim JY, Lew DH, Roh TS, Lee DW. Robotic DIEP Flap Harvest through a Totally Extraperitoneal Approach Using a Single-Port Surgical Robotic System. Plast Reconstr Surg. 2021 Aug 1;148(2):304-307. doi: 10.1097/PRS.0000000000008181.
PubMed 34398082
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation
- ClinicalTrials.gov ID
- NCT07222514
- Acronym / sponsor ID
- (DIEP) / 250009
- Conditions
- DIEP Flap Breast Reconstruction
- Keywords
- DIEP flap breast reconstruction, Robotic Surgery, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- 20 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Oct 2025 (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 primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction. The investigators will also investigate complications of the procedure, incision length, flap success rate, post operative pain, vascular pedicle length and caliber, and VMP-B score (quality of life/satisfaction of breast procedures survey).
Detailed description
This project will be conducted at Vanderbilt University Medical Center. Patients scheduled for a DIEP flap procedure will be recruited through screening of the electronic medical records (EMR) to evaluate eligibility based on pre-established inclusion and exclusion criteria. Eligible patients will be invited to participate in a preoperative consultation, during which they will receive detailed information about the study, including the surgical techniques, potential risks, and benefits. Written informed consent will be obtained from those who agree to participate.
Baseline data available in the medical records as part of their clinical care, including patient demographics, medical history, imaging, pictures, pain and quality-of-life metrics, will also be collected.
On the day of surgery, patients will undergo standard preoperative preparations. The procedure will involve robotic-assisted DIEP flap harvest using single-port access, followed by flap transfer and microsurgical anastomosis. Post-surgical donor site closure will employ techniques to minimize morbidity. Key intraoperative data, such as operative time and complications, will be recorded.
Patient Electronic Medical Records (EMR) will be accessed by research personnel to monitor patients who elect to have the proposed procedure. Postoperative monitoring will focus on flap viability and patient recovery during the hospital stay and subsequent follow-ups. Assessments will include complications, donor site integrity, pain levels, and patient-reported outcomes. Follow-up visits will evaluate both short- and long-term outcomes, including satisfaction and quality of life, providing comprehensive data for the study's primary and secondary aims.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted DIEP Breast Reconstruction | Experimental | Device: Single-Port Robotic SystemThis group consists of patients receiving the investigative procedure - robotic assisted DIEP flap harvest for breast reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged ≥18 years.
- Candidates for unilateral or bilateral breast reconstruction using a DIEP flap.
- No contraindications for general anesthesia or robotic surgery.
- Patients with adequate abdominal donor tissue for DIEP flap harvest.
Key exclusion criteria (9 listed)
- History of prior abdominal surgery that significantly compromises perforator vessel integrity.
- Pregnant woman.
- Prisoners.
- BMI > 35, as measured during the preoperative evaluation.
- Presence of comorbidities that contraindicate elective surgery.
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 |
|---|---|---|
| Single-Port Robotic SystemUtilizing the Single-Port robotic system for DIEP flap harvest has been previously described, but only in a small pilot study. The investigators plan to demonstrate the feasibility and safety of this approach on a larger cohort of patients. | Device | Robotic Assisted DIEP Breast Reconstruction |
Primary outcome
Feasibility of performing DIEP flap breast construction using a single port robotic system
Time frame: From enrollment to the end of the procedure.
This will be "Yes" if the following are true of the procedure: completed pedicle dissection using the robotic system, adequate pedicle dissected, and no intraoperative complication requiring conversion to the open approach.
9 secondary outcomes
Complication Rates
Time frame: Through study completion, an average of 1 year.
Fascial Incision Length
Time frame: Through study completion, an average of 1 year.
Flap Success Rate
Time frame: From procedure to 7 days post operation.
Operative Time
Time frame: From procedure start to procedure completion.
Pain Level
Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Length
Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)
Vanderbilt Mini Patient Reported Outcome - Breast (VMP-B) Score
Time frame: From enrollment to 12 months post operation. Surveys will be distributed preoperatively and at postoperative follow up intervals (2 weeks, 6 weeks, 3 months, 6 months, and 12 months).
Pain Management
Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Caliber
Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)
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 27 May 2026.
- Background: PubMed 37568353Roy N, Alessandro CJ, Ibelli TJ, Akhavan AA, Sharaf JM, Rabinovitch D, Henderson PW, Yao A. The Expanding Utility of Robotic-Assisted Flap Harvest in Autologous Breast Reconstruction: A Systematic Review. J Clin Med. 2023 Jul 27;12(15):4951. doi: 10.3390/jcm12154951.
- Background: PubMed 36995211Tsai CY, Kim BS, Kuo WL, Liu KH, Chang TN, Cheong DC, Huang JJ. Novel Port Placement in Robot-Assisted DIEP Flap Harvest Improves Visibility and Bilateral DIEP Access: Early Controlled Cohort Study. Plast Reconstr Surg. 2023 Oct 1;152(4):590e-595e. doi: 10.1097/PRS.0000000000010470. Epub 2023 Mar 30.
- Background: PubMed 36185209Lee MJ, Won J, Song SY, Park HS, Kim JY, Shin HJ, Kwon YI, Lee DW, Kim NY. Clinical outcomes following robotic versus conventional DIEP flap in breast reconstruction: A retrospective matched study. Front Oncol. 2022 Sep 14;12:989231. doi: 10.3389/fonc.2022.989231. eCollection 2022.
- Background: PubMed 34398082Choi JH, Song SY, Park HS, Kim CH, Kim JY, Lew DH, Roh TS, Lee DW. Robotic DIEP Flap Harvest through a Totally Extraperitoneal Approach Using a Single-Port Surgical Robotic System. Plast Reconstr Surg. 2021 Aug 1;148(2):304-307. doi: 10.1097/PRS.0000000000008181.
- Individual participant dataSharing planned: No. As this is a feasibility study - there is no indication to share individual participant data.
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The Effect of a Post-operative Exercise Programme Versus Standard Care on Physical Fitness of Patients With Breast Cancer Undergoing Deep Inferior Epigastric Perforator (DIEP) Flap Reconstruction Surgery
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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.
Jun Yao contact
Galen Perdiks, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Port Robotic System in people with DIEP Flap Breast Reconstruction, run by Vanderbilt University Medical Center at 1 site in United States.
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 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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 United States. 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 Emmanuel Giannas, MD (6154033398, e.giannas@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of performing DIEP flap breast construction using a single port robotic system (time frame: From enrollment to the end of the procedure.). 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 NCT07222514, which also lists 4 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 27 May 2026.