Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •The subject has a BMI >
- •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.
研究组 & 干预措施
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.
干预措施: da Vinci® Robotic Surgical System (Device)
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.
干预措施: LD muscle flap harvest procedure (Procedure)
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.
干预措施: Reconstructive surgery (Procedure)
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.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability
时间窗: 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
时间窗: Participants were followed for up to a total of 6 months post-operatively
次要结局
- LD Muscle Flap Failure Through 6 Months Post-procedure(Participants were followed for up to a total of 6 months post-operatively)
- Evaluation of Donor Site Complications Through 6 Months Post-procedure(Participants were followed for up to a total of 6 months post-operatively)