Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2015-07-08
2018-03-07
Brief Summary
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Detailed Description
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If it is determined that participant is eligible, the following will be performed before the surgery:
* The study doctor or a member of the research team will review participant's medical information and ask participant questions about participant's medical history and demographic information.
* Participant will have a physical exam.
* Participant will be evaluated by a Physical Therapist to test participant's range of motion and strength.
* Participant will complete a questionnaire about pain, as well as participant's shoulder, arm, and hand range of motion. This information will be used to compare with the results after the surgery. This will take about 5 minutes to complete.
* Photographs and/or videos of the surgical site will be taken.
* If participant can become pregnant, participant will have a urine pregnancy test. To take part in this study, participant must not be pregnant.
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:
* The study doctor will check the surgery site(s).
* Participant's overall health status will be checked.
* Participant will be evaluated by a Physical Therapist to test participant's range of motion and strength.
* Photographs and/or videos of the surgical site may be taken.
* Participant will complete the questionnaire about pain and participant's shoulder, arm, and hand range of motion. This information will be used to compare with the results from before the surgery.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robotic Harvest of the LD Muscles
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.
da Vinci® Robotic Surgical System
Da Vinci Robotic Surgical system to be used in procedures that harvest the latissimus dorsi muscle for reconstructive procedures
LD muscle flap harvest procedure
Latissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery.
Reconstructive surgery
Reconstructive surgery is considered to be standard of care.
Questionnaires
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.
Interventions
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da Vinci® Robotic Surgical System
Da Vinci Robotic Surgical system to be used in procedures that harvest the latissimus dorsi muscle for reconstructive procedures
LD muscle flap harvest procedure
Latissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery.
Reconstructive surgery
Reconstructive surgery is considered to be standard of care.
Questionnaires
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject must be willing and able to provide informed consent.
3. The subject is willing and able to comply with the study protocol.
4. 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.
5. The subject agrees to follow-up examinations out to 6 months post-treatment.
Exclusion Criteria
2. The subject has a history of significant bleeding disorders.
3. The subject is diabetic.
4. The subject is known or suspected to be pregnant or lactating.
5. The subject has a history of peripheral vascular disease.
6. The subject is a current smoker (has smoked within 4 weeks prior to surgery).
7. The subject has had prior back or axillary surgeries which could compromise the blood supply of the flap.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jesse C. Selber, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Official Website
Other Identifiers
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NCI-2015-00616
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013-0232
Identifier Type: -
Identifier Source: org_study_id
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