N/A
N=15
Robotic Harvest of the Latissimus Dorsi (LD) Muscles
Other Reconstructive Surgery · Failure of Muscle Graft · Cancer · Complications · Surgical Procedure, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT02274493 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- da Vinci® Robotic Surgical System (Device); LD muscle flap harvest procedure (Procedure); Reconstructive surgery (Procedure); Questionnaires (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability |
15 | — |
| PRIMARY Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure |
15 | — |
| SECONDARY Evaluation of Donor Site Complications Through 6 Months Post-procedure |
14 | — |
| SECONDARY LD Muscle Flap Failure Through 6 Months Post-procedure |
— | — |
Summary
The goal of this clinical research study is to learn more about the safety and feasibility of using the Da Vinci Robotic Surgical system in procedures that harvest the latissimus dorsi muscle (a back muscle below your shoulder) for reconstructive procedures.
Eligibility Criteria
Inclusion Criteria
- The subject must be equal to or greater than 18 years of age.
- The subject must be willing and able to provide informed consent.
- The subject is willing and able to comply with the study protocol.
- The subject is undergoing one of the following reconstructive procedures that requires latissimus dorsi muscle harvest: a. Post-mastectomy breast reconstruction procedure (either nipple or skin sparing) in which a female subject needs additional muscle coverage over an implant, but does not need additional skin (i.e., patient is a candidate for a pedicled latissimus dorsi muscle flap procedure); b. Scalp reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; c. Upper extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; or, d. Lower extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage.
- The subject agrees to follow-up examinations out to 6 months post-treatment.
Exclusion Criteria
- The subject has a BMI > 35.
- The subject has a history of significant bleeding disorders.
- The subject is diabetic.
- The subject is known or suspected to be pregnant or lactating.
- The subject has a history of peripheral vascular disease.
- The subject is a current smoker (has smoked within 4 weeks prior to surgery).
- The subject has had prior back or axillary surgeries which could compromise the blood supply of the flap.
Data sourced from ClinicalTrials.gov (NCT02274493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.