Robotic Harvest of the Latissimus Dorsi (LD) Muscles

NCT02274493 | Completed Results FDA Device

• 2 other identifiers: 2013-0232NCI-2015-00616
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Evaluation of Donor Site Complications Through 6 Months Post-procedure

  Participants were followed for up to a total of 6 months post-operatively

• LD Muscle Flap Failure Through 6 Months Post-procedure

  Participants were followed for up to a total of 6 months post-operatively

Study Arms (1)

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.

Device: da Vinci® Robotic Surgical System; Procedure: LD muscle flap harvest procedure; Procedure: Reconstructive surgery; Behavioral: Questionnaires

Interventions

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

Also known as: Robotic surgery

Robotic Harvest of the LD Muscles

LD muscle flap harvest procedure PROCEDURE

Latissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery.

Robotic Harvest of the LD Muscles

Reconstructive surgery PROCEDURE

Reconstructive surgery is considered to be standard of care.

Robotic Harvest of the LD Muscles

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.

Also known as: Surveys

Robotic Harvest of the LD Muscles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Neoplasms

Interventions

Robotic Surgical Procedures; Plastic Surgery Procedures; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Jesse C Selber / Professor, Plastic Surgery
• Organization: UT MD Anderson Cancer Center

jcselber@mdanderson.org

713-794-1297

Study Officials

• Jesse C. Selber, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: July 8, 2015
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: March 26, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-03

Locations

US (1)