Single-Port Robotic Surgery for Breast Reconstruction
((DIEP) Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for breast reconstruction surgery using a single-port robotic system. The goal is to determine the feasibility and effectiveness of this technique, focusing on surgery success, incision size, and patient comfort post-surgery. It suits women needing breast reconstruction who have sufficient abdominal tissue for donation. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research in surgical innovation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team or your doctor.
What prior data suggests that this single-port robotic surgery is safe for breast reconstruction?
Research has shown that a single-port robotic-assisted method for the DIEP flap procedure is a well-established option for breast reconstruction. Studies on similar robotic-assisted techniques suggest they can lessen pain and reduce the need for painkillers after surgery, enhancing patient comfort during recovery.
The DIEP flap method has long been used in breast reconstruction and is known for its reliability and effectiveness. Robotic assistance in this surgery may enhance surgical precision, potentially reducing complications.
While specific data on the single-port approach is still being collected, existing research on robotic-assisted methods appears promising for patient safety.12345Why are researchers excited about this trial?
Single-port robotic-assisted breast reconstruction is unique because it offers a less invasive way to perform the surgery needed for DIEP flap breast reconstruction. Traditional methods involve larger incisions and more extensive manual techniques, which can lead to longer recovery times and more noticeable scarring. In contrast, this robotic approach uses a single small incision, which could mean quicker recovery, reduced pain, and less visible scarring. Researchers are excited because this method has the potential to significantly improve patient experience and outcomes in breast reconstruction.
What evidence suggests that single-port robotic surgery is effective for breast reconstruction?
Research has shown that a robotic method for DIEP flap breast reconstruction, which participants in this trial will receive, reduces the risk of flap failure and complications. Studies indicate that patients recover better, experiencing less pain and shorter hospital stays compared to traditional methods. The robotic technique allows for greater precision, potentially leading to higher success rates and satisfaction with the procedure. These findings suggest that robotic-assisted surgery could be a promising option for breast reconstruction.23678
Who Is on the Research Team?
Galen Perdiks, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for women over 18 needing breast reconstruction with DIEP flap, who have enough abdominal tissue and no general anesthesia or robotic surgery contraindications. Exclusions include BMI >35, prior surgeries affecting vessels, active cancers besides breast cancer, metastatic disease, and inability to follow up.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Consultation
Eligible patients receive detailed information about the study, including surgical techniques, potential risks, and benefits. Written informed consent is obtained.
Surgery and Immediate Postoperative Care
Patients undergo robotic-assisted DIEP flap harvest using single-port access, followed by flap transfer and microsurgical anastomosis. Post-surgical donor site closure is performed.
Postoperative Monitoring
Monitoring focuses on flap viability and patient recovery, including assessments of complications, donor site integrity, pain levels, and patient-reported outcomes.
Follow-up
Participants are monitored for short- and long-term outcomes, including satisfaction and quality of life. Follow-up visits evaluate both short- and long-term outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Intuitive Surgical
Industry Sponsor
Gary Guthart
Intuitive Surgical
Chief Executive Officer since 2010
PhD in Engineering, California Institute of Technology
Henry Charlton
Intuitive Surgical
Chief Medical Officer since 2023
MD from an unspecified institution