NCT02274493

Robotic Harvest of the Latissimus Dorsi (LD) Muscles

Completed NA Results posted Last updated 26 March 2019

What this trial tests

NA trial testing da Vinci® Robotic Surgical System in Other Reconstructive Surgery in 15 participants. Completed in 7 March 2018.

Timeline

8 July 2015

Primary endpoint
7 March 2018

7 March 2018

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	8 July 2015
Primary completion	7 March 2018
Estimated completion	7 March 2018
Sites	1 location across United States

Drugs / interventions tested

• da Vinci® Robotic Surgical System
• LD muscle flap harvest procedure
• Reconstructive surgery
• Questionnaires

Conditions studied

• Other Reconstructive Surgery — all drugs for Other Reconstructive Surgery →
• Failure of Muscle Graft — all drugs for Failure of Muscle Graft →
• Cancer — all drugs for Cancer →
• Complications — all drugs for Complications →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Other Reconstructive Surgery or Failure of Muscle Graft. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability Primary · 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

Group	Value	95% CI
Latissimus Dorsi Muscle Harvest	15

Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure Primary · Participants were followed for up to a total of 6 months post-operatively

Group	Value	95% CI
Latissimus Dorsi Muscle Harvest	15

Evaluation of Donor Site Complications Through 6 Months Post-procedure Secondary · Participants were followed for up to a total of 6 months post-operatively

The participants listed were evaluated for donor site complication.

Group	Value	95% CI
Latissimus Dorsi Muscle Harvest	14

LD Muscle Flap Failure Through 6 Months Post-procedure Secondary · Participants were followed for up to a total of 6 months post-operatively

Flap failure is defined as irreversible arterial and venous thrombosis detected by implantable or surface doppler signal.

Group	Value	95% CI
Latissimus Dorsi Muscle Harvest	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects were followed for a total of 6 months post-operatively. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Latissimus Dorsi Muscle Harvest

Serious: 1/15 (7%)

Deaths: 0/15

Serious adverse events (1 terms)

Reaction	System	Latissimus Dorsi Muscle Ha…
Infection	Infections and infestations	—

Other adverse events (2 terms — click to expand)

Reaction	System	Latissimus Dorsi Muscle Ha…
Infection	Infections and infestations	—
Seroma	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Infection.

Data from ClinicalTrials.gov NCT02274493 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. [Robotic Surgery - Who is The Boss?]
   Schuler PJ. · · 2018 · cited 6× · PMID 29905359 · DOI 10.1055/s-0043-121791
2. Recent Advancements of Nanomedicine in Breast Cancer Surgery.
   Meng X, Wang X, Zhang Z, Song L, et al · · 2024 · cited 5× · PMID 39759962 · DOI 10.2147/ijn.s494364