Other Reconstructive SurgeryNCT02274493
Robotic Harvest of the Latissimus Dorsi (LD) Muscles
A study testing da Vinci® Robotic Surgical System, LD muscle flap harvest procedure and Reconstructive surgery in people with Other Reconstructive Surgery and Failure of Muscle Graft, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Reconstructive Surgery, Failure of Muscle Graft, Cancer
- What is being tested?
- da Vinci® Robotic Surgical System, LD muscle flap harvest procedure and Reconstructive surgery
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2015to 7 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscles
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.
Read the detailed description
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:
- 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
- Other Reconstructive Surgery, Failure of Muscle Graft, Cancer, Complications, Surgical Procedure, Unspecified
- Being tested
- da Vinci® Robotic Surgical System, LD muscle flap harvest procedure, Reconstructive surgery, Questionnaires
- Keywords
- da Vinci® robotic surgical system, latissimus dorsi muscle flap harvest procedures, breast reconstruction, scalp reconstruction, upper extremity reconstruction, lower extremity reconstruction
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci® Robotic Surgical SystemDevice
Also called Robotic surgery
Da Vinci Robotic Surgical system to be used in procedures that harvest the latissimus dorsi muscle for reconstructive procedures
LD muscle flap harvest procedureProcedure or surgery
Latissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery.
Reconstructive surgeryProcedure or surgery
Reconstructive surgery is considered to be standard of care.
QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: da Vinci® Robotic Surgical System; Procedure: LD muscle flap harvest procedure; Procedure: Reconstructive surgery; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Participants were followed for up to a total of 6 months post-operatively
Secondary outcomes (2)
Evaluation of Donor Site Complications Through 6 Months Post-procedure
The participants listed were evaluated for donor site complication.
Measured: Participants were followed for up to a total of 6 months post-operatively
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.
Measured: Participants were followed for up to a total of 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start8 Jul 2015
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Other Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesse C. Selber, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274493
- Sponsor's protocol ID
- 2013-0232
- Other IDs
- NCI-2015-00616
- Status last verified
- Mar 2019
- First submitted
- 22 Oct 2014
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscles
- ClinicalTrials.gov ID
- NCT02274493
- Acronym / sponsor ID
- 2013-0232
- Conditions
- Other Reconstructive Surgery, Failure of Muscle Graft, Cancer, Complications, Surgical Procedure, Unspecified
- Keywords
- da Vinci® robotic surgical system, latissimus dorsi muscle flap harvest procedures, breast reconstruction, scalp reconstruction, upper extremity reconstruction, lower extremity reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Harvest of the LD Muscles | Experimental | Device: da Vinci® Robotic Surgical System, Procedure: LD muscle flap harvest procedure, Procedure: Reconstructive surgery, Behavioral: QuestionnairesSurgical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| da Vinci® Robotic Surgical SystemAlso: Robotic surgeryDa Vinci Robotic Surgical system to be used in procedures that harvest the latissimus dorsi muscle for reconstructive procedures | Device | Robotic Harvest of the LD Muscles |
| LD muscle flap harvest procedureLatissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery. | Procedure or surgery | Robotic Harvest of the LD Muscles |
| Reconstructive surgeryReconstructive surgery is considered to be standard of care. | Procedure or surgery | Robotic Harvest of the LD Muscles |
| QuestionnairesAlso: SurveysQuestionnaire about pain, as well as participant's shoulder, arm, and hand range of motion completed at baseline, and at follow up visits 3-6. | Behavioural | Robotic Harvest of the LD Muscles |
Primary outcome
Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability
Time frame: Participants were followed for up to a total of 6 months post-operatively
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
Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure
Time frame: Participants were followed for up to a total of 6 months post-operatively
2 secondary outcomes
Evaluation of Donor Site Complications Through 6 Months Post-procedure
Time frame: Participants were followed for up to a total of 6 months post-operatively
LD Muscle Flap Failure Through 6 Months Post-procedure
Time frame: Participants were followed for up to a total of 6 months post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse C. Selber, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci® Robotic Surgical System, LD muscle flap harvest procedure and Reconstructive surgery in people with Other Reconstructive Surgery and Failure of Muscle Graft, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability (time frame: Participants were followed for up to a total of 6 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.