Robotic Assisted Surgery for Colorectal Cancer

Recruiting at 9 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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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 resections or right colectomy.

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 data supports the effectiveness of the treatment da Vinci SP Surgical System for colorectal cancer?

The da Vinci SP Surgical System has shown promising results in initial studies for colorectal cancer, demonstrating safety and technical feasibility in single-incision surgeries, which can reduce the need for multiple incisions and potentially improve recovery times. ^{1 2 3 4 5}

Is robotic-assisted surgery with the da Vinci SP system safe for humans?

Research on the da Vinci SP system for colorectal surgery shows it is generally safe, with studies reporting successful surgeries and favorable short-term results. Although most studies focus on small groups, they suggest the system is safe for use in humans. ^{1 2 5 6 7}

How is the da Vinci SP Surgical System treatment different from other treatments for colorectal cancer?

The da Vinci SP Surgical System is unique because it allows for single-incision robotic surgery, reducing the need for multiple incisions typically required in traditional robotic surgeries. This system is designed to work in narrow spaces, making it particularly suitable for colorectal procedures, and it has shown promising results in terms of safety and performance. ^{1 2 4 5 6}

Research Team

Madhu L Gorrepati

Principal Investigator

Clinical Affairs Director

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

An initial experience with a novel technique of single-port robotic resection for rectal cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Single-Port Robotic Intersphincteric Resection for the Treatment of Rectal Cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A prospective phase II clinical trial/IDEAL Stage 2a series of single-port robotic colorectal surgery for abdominal and transanal cases. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience of Pure Single-Incision Robotic Right Hemicolectomy with da Vinci SP Platform. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Da Vinci SP robotic approach to colorectal surgery: two specific indications and short-term results. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

rSILS: initial clinical experience with single-port robotic (SPr) right colectomy. [2021]