Robotic Assisted Surgery for Colorectal Cancer

Not currently recruiting at 11 trial locations

Overseen By Janet Shelly

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Intuitive Surgical

Disqualifiers: Metastatic disease, Life expectancy <6 months, Inflammatory bowel disease, Bleeding/clotting disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to confirm the safety and effectiveness of the da Vinci SP Surgical System for complex colorectal surgeries, such as low anterior resection or right colectomy. It focuses on using robotic assistance for these procedures, which may offer benefits like smaller incisions and quicker recovery. The trial seeks participants who are 18 or older, have a BMI of 35 or less, and require specific colorectal surgeries suitable for robotic assistance. Participants must attend follow-up visits after surgery.

As an unphased trial, this study allows participants to contribute to advancing surgical technology and potentially experience innovative treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the da Vinci SP Surgical System is safe for colorectal procedures?

Research has shown that the da Vinci SP Surgical System is both practical and safe for colorectal surgeries. A review found that this robotic-assisted system delivers promising short-term results. Studies have indicated less blood loss and fewer conversions to traditional surgery methods with the da Vinci system. Patients generally tolerate the system well during surgeries. No reports of serious safety issues exist, making it a reliable choice for complex procedures like low anterior resections and right colectomies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic-assisted surgery for colorectal cancer because it offers a precise and minimally invasive alternative to traditional surgical methods. The da Vinci SP Surgical System allows surgeons to perform complex procedures with enhanced dexterity and control, potentially leading to quicker recovery times and fewer complications for patients compared to conventional open or laparoscopic surgeries. This advanced system uses a single-port approach, which can result in smaller incisions, less pain, and a faster return to normal activities.

What evidence suggests that the da Vinci SP Surgical System is effective for colorectal cancer surgery?

Research has shown that the da Vinci SP Surgical System, used in this trial, holds promise for colorectal cancer surgery. Studies indicate it is safe and effective, yielding good short-term results. Patients have experienced less blood loss and fewer modifications to other surgical methods with this system. In some studies, surgeons did not need to switch to laparoscopy, unlike with other robotic systems. Overall, the da Vinci SP is a reliable choice for complex colorectal surgeries. ^{1 2 3 5 6}

Who Is on the Research Team?

Madhu L Gorrepati

Principal Investigator

Clinical Affairs Director

Are You a Good Fit for This Trial?

Adults with colorectal cancer who need complex surgery and have a BMI ≤ 35, ASA score ≤ 3 (indicating they're fit for surgery), and no widespread cancer. They must be able to follow the study plan, including visits up to 5 years after surgery.

Inclusion Criteria

I can follow the study's schedule for check-ups and long-term follow-up for 5 years.

BMI ≤ 35

Willing and able to provide a written informed consent document

Exclusion Criteria

I am having surgery for both lower rectum cancer and right colon cancer at the same time.

I am scheduled for or might need a major surgery soon.

My colonoscopy showed I have cancer in different parts of my colon at the same time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Colorectal procedure performed using the da Vinci SP Surgical System

Intraoperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

42 days

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci SP Surgical System

Trial Overview

The trial is testing the safety and performance of the da Vinci SP Surgical System in single-port robotic-assisted surgeries like low anterior resections or right colectomies for colorectal cancer.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

Colorectal procedure will be performed by da Vinci SP® Surgical System

da Vinci SP Surgical System is already approved in United States for the following indications:

Approved in United States as da Vinci SP Surgical System for:

• Urological procedures including radical prostatectomy, pyeloplasty, nephrectomy, partial nephrectomy
• Simple prostatectomy for benign prostatic hyperplasia (BPH) or enlarged prostate
• Transvesical approach to simple and radical prostatectomy

Who Is Running the Clinical Trial?

Intuitive Surgical

Lead Sponsor

Trials

80

Recruited

49,600+

Gary Guthart

Intuitive Surgical

Chief Executive Officer since 2010

PhD in Engineering, California Institute of Technology

Henry Charlton

Intuitive Surgical

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

The da Vinci SP® surgical system was evaluated in a study involving 50 patients undergoing various colorectal procedures, demonstrating significant reductions in operative time as experience with the system increased, indicating improved efficiency.

The study found that the dVSP system is safe for colorectal surgery, with only six mild adverse events reported and no local recurrences, suggesting it is a promising option for oncological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. Kim, HS., Oh, BY., Cheong, C., et al.[2023]

The study evaluated the safety and feasibility of the da Vinci single-port robotic system for rectal resection in 5 patients with mid or low rectal cancer, showing promising results with all patients achieving tumor-free resection margins.

The median operation time was 195 minutes, and while one patient had an anastomosis-related complication, the overall outcomes suggest that single-port robotic surgery is a viable option that warrants further investigation against traditional multiport methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial experience with a novel technique of single-port robotic resection for rectal cancer. Kim, HJ., Choi, GS., Song, SH., et al.[2021]

The first successful single-port robotic right colectomy in the USA was performed using the da Vinci SP robot, demonstrating its feasibility and safety with no intraoperative complications and minimal blood loss (100 mL).

The patient had a smooth recovery, tolerating a low-residue diet by postoperative day 1 and being discharged by day 3, indicating that the SP robotic approach may enhance recovery times in colorectal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rSILS: initial clinical experience with single-port robotic (SPr) right colectomy. Marks, JH., Kunkel, E., Salem, J., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39369142/

Evaluation of the da Vinci single-port system in colorectal ...

The Da Vinci SP robotic platform demonstrates promising safety and effectiveness in colorectal cancer surgery.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11965226/

A systematic review of the Da Vinci® Single-Port system ...

This study shows that the use of DVSP in colorectal surgery is both feasible and safe. Short-term clinical and oncological outcomes seem promising.

3.

intuitive.com

intuitive.com/en-us/about-us/company/research-outcomes

Da Vinci Research and Outcomes

A review of 55 studies found robotic-assisted surgery (RAS) with the da Vinci system led to lower blood loss, fewer conversions, fewer blood transfusions, ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2468900925000684

Comparison of outcomes in robot-assisted colon cancer ...

No conversions occurred in the da Vinci group, whereas 2 and 3 conversions to laparoscopy were recorded with Hugo™ RAS and Versius®, ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/rcs.70079

Robot‐Assisted Colectomy for Left‐Sided Colon Cancer ...

To compare the clinicopathological and cosmetic outcomes of robotic colectomy using the da Vinci SP and Single-Site for left-sided colon cancer.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04403022

da Vinci SP® Investigational Device Exemption Study in ...

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior ...