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Tests treatment safety and results for DIEP Flap Breast Reconstruction
Official title Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest
ClinicalTrials.gov ID: NCT07222514
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
- Active metastatic disease confirmed via imaging or biopsy.
- Inability to comply with follow-up visits.
- The research team decides to exclude the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.