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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00616 | Registry Identifier | NCI CTRP |
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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.
If participant is found to be eligible to take part in this study, and participant agrees, participant's screening, reconstructive surgery, and follow-up appointments will be scheduled over multiple visits, as listed in this consent form. All procedures will be performed on days in which standard of care procedures would already be performed.
If it is determined that participant is eligible, the following will be performed before the surgery:
Surgery Study Visit (2):
At this visit, participant's reconstructive surgery will be performed using a robot, called the Da Vinci® Robotic Surgical System. The reconstructive surgery is considered to be standard of care. Participant will be asked to sign a separate consent form that discusses the possible benefits and risks of the standard of care surgical procedure in more detail, including information about any anesthetic participant will be given for the surgery.
A standard muscle harvest procedure takes about 2 hours. A muscle harvest procedure with the robotic system is expected to take longer than the standard surgery. The total procedure time will vary for each patient depending on the type of muscle harvest procedure and other factors in the operating room. The total time to complete the muscle harvest and reconstruction will take about 4 hours. Photographs and/or videos of the surgical site will be taken.
Participant will remain in the hospital for 3-4 days after the surgery is complete for observation. After participant is discharged from the hospital, participant will need to return within 2 weeks for participant's first follow-up examination.
Follow-Up Study Visits (3-6):
After participant has been discharged from the hospital, participant will have 4 follow-up visits.
The first follow up visit will take place within two weeks after participant is discharged . The second follow-up visit will be between 2-4 weeks, the third follow up visit will be between 1-3 months and the fourth follow up will be between 3-6 months after participant is discharged.
The following tests and procedures will be performed at each follow-up visit:
Length of Study Participation:
Participation on the study will be over after the follow-up visits.
This is an investigational study. The use of the Da Vinci® Robotic Surgical System for surgery in the thorax (part of the upper body) is FDA approved and commercially available at this time. However, the system has not been FDA cleared specifically for use in latissimus dorsi muscle harvest procedures. The use of the DaVinci Robotic Surgical System for this type of reconstructive surgery has not been performed in live humans and is what researchers are investigating for this study.
Up to 15 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Harvest of the LD Muscles | Experimental | Surgical harvesting of the Latissimus Dorsi (LD) Muscles using da Vinci® robotic surgical system in participants undergoing LD muscle flap harvest procedures in conjunction with breast, scalp, upper extremity and lower extremity reconstructive surgery procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci® Robotic Surgical System | Device | Da Vinci Robotic Surgical system to be used in procedures that harvest the latissimus dorsi muscle for reconstructive procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability | Muscle flap viability was determined by measuring the blood flow into and out of the muscle flap with a hand held Doppler after muscle harvest was complete | Participants were followed for up to a total of 6 months post-operatively |
| Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure | Participants were followed for up to a total of 6 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Donor Site Complications Through 6 Months Post-procedure | The participants listed were evaluated for donor site complication. | Participants were followed for up to a total of 6 months post-operatively |
| LD Muscle Flap Failure Through 6 Months Post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse C. Selber, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Latissimus Dorsi Muscle Harvest | Latissimus dorsi muscle harvest using the DaVinci robotic approach |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Latissimus Dorsi Muscle Harvest | Latissimus dorsi muscle harvest using the DaVinci robotic approach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability | Muscle flap viability was determined by measuring the blood flow into and out of the muscle flap with a hand held Doppler after muscle harvest was complete | All participants were assessed for the primary measure | Posted | Count of Participants | Participants | No | Participants were followed for up to a total of 6 months post-operatively |
|
|
Subjects were followed for a total of 6 months post-operatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Latissimus Dorsi Muscle Harvest | Latissimus dorsi muscle harvest using the DaVinci robotic approach |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jesse C Selber / Professor, Plastic Surgery | UT MD Anderson Cancer Center | 713-794-1297 | jcselber@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2016 | Nov 28, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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|
| LD muscle flap harvest procedure | Procedure | Latissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery. |
|
| Reconstructive surgery | Procedure | Reconstructive surgery is considered to be standard of care. |
|
| Questionnaires | Behavioral | Questionnaire about pain, as well as participant's shoulder, arm, and hand range of motion completed at baseline, and at follow up visits 3-6. |
|
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Flap failure is defined as irreversible arterial and venous thrombosis detected by implantable or surface doppler signal. |
| Participants were followed for up to a total of 6 months post-operatively |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Latissimus dorsi muscle function | Count of Participants | Participants | No |
|
| Participants |
|
|
| Primary | Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure | Posted | Count of Participants | Participants | Participants were followed for up to a total of 6 months post-operatively |
|
|
|
| Secondary | Evaluation of Donor Site Complications Through 6 Months Post-procedure | The participants listed were evaluated for donor site complication. | 1 participant withdrew study consent prior to post-procedure follow up visits. | Posted | Count of Participants | Participants | No | Participants were followed for up to a total of 6 months post-operatively |
|
|
|
| Secondary | LD Muscle Flap Failure Through 6 Months Post-procedure | Flap failure is defined as irreversible arterial and venous thrombosis detected by implantable or surface doppler signal. | 1 participant withdrew study consent prior to post-procedure follow up visits. | Posted | Count of Participants | Participants | No | Participants were followed for up to a total of 6 months post-operatively |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 1 |
| 15 |
| Seroma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |