Single Port Robotic Surgery for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Pallavi Vaidya, BPharm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ankit Sarin

Disqualifiers: Severe systemic disease, Advanced cancer, Chemotherapy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

25 Participants Needed

Trial Summary

What is the purpose of this trial?

Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

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 single port robotic colorectal surgical procedure treatment?

Research shows that single-port robotic surgery for colorectal cancer is technically feasible and safe, with studies highlighting its ability to perform complex procedures in narrow spaces and maintain cosmetic benefits. Additionally, robotic surgery has been established as an effective method for treating colorectal cancers, comparable to traditional laparoscopic surgery. ^{1 2 3 4 5}

Is single-port robotic surgery for colorectal cancer safe?

Research shows that single-port robotic surgery for colorectal cancer is generally considered safe, with studies focusing on its technical feasibility and initial complications. Safety and feasibility have been reported to improve over time, although implementing such programs in busy centers can be challenging. ^{1 2 6 7 8}

How is single port robotic surgery different from other treatments for colorectal cancer?

Single port robotic surgery for colorectal cancer is unique because it uses a single incision to perform the surgery, which can lead to better cosmetic outcomes and potentially less pain and faster recovery compared to traditional multi-port surgeries. This approach also allows for precise surgical movements in tight spaces, thanks to advanced robotic technology. ^{1 2 3 4 9}

Research Team

Ankit Sarin, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for adults over 18 with colorectal conditions like rectal prolapse or cancer, requiring surgery. Candidates must be in good health, not pregnant or lactating if female, and able to consent. Excluded are those with severe diseases, advanced cancer, prior chemo or radiation therapy, emergency operation needs, or inability to follow up.

Inclusion Criteria

I am 18 years old or older.

Subject agrees to comply with the requirements of the protocol and complete study measures

Subject must have been practicing one of the following methods of contraception consistently for at least 1 month prior to study entry if of childbearing potential

Exclusion Criteria

Subject falls under American Society of Anesthesia Class V

Subject falls under American Society of Anesthesia Class IV

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colorectal surgical procedures using the Intuitive Da Vinci Single Port SP system

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and quality outcomes post-surgery

4 weeks

1 visit (in-person), additional follow-up as needed

Treatment Details

Interventions

• Single port robotic colorectal surgical procedure

Trial Overview The study tests a new Single Port (SP) robotic technology for colorectal surgeries against the standard multiport system. It aims to determine if the SP method is safe and effective for these types of surgeries which have been previously approved only for head and neck and urology procedures.

Participant Groups

Group I: Single Port Robotic Surgery Arm Experimental Treatment 1 Intervention

Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system

Who Is Running the Clinical Trial?

Ankit Sarin

Lead Sponsor

Trials

1

Recruited

30+

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Ankit Sarin, MD, MHA

Lead Sponsor

Trials

1

Recruited

30+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Henry Ford Hospital

Collaborator

Trials

27

Recruited

7,400+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Findings from Research

The study analyzed 39 patients undergoing single-port robotic (SPR) colectomy, revealing that the learning curve for the surgeon was reached after performing 18 surgeries, indicating a significant improvement in efficiency over time.

While the average operation time was 186.59 minutes, complications occurred in 8 patients, highlighting the need for careful monitoring during the initial phase of adopting this surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning curve for single-port robot-assisted colectomy. Choi, MS., Yun, SH., Lee, SC., et al.[2022]

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 study involved 11 patients undergoing reduced-port robotic surgery (RPRS) for left-sided colon cancer, demonstrating that this technique is feasible and safe.

Patients experienced a mean operation time of 289 minutes and a mean hospital stay of 7.4 days, with an average of 18.7 lymph nodes harvested, indicating effective surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced-port robotic anterior resection for left-sided colon cancer using the Da Vinci single-site(®) platform. Bae, SU., Jeong, WK., Bae, OS., et al.[2022]

Robotic reduced-port surgery for left-sided colorectal cancer is safe and effective, showing comparable outcomes to conventional laparoscopic surgery in most measures, including reoperation rates and survival.

However, the robotic approach is significantly more expensive, with total hospital costs averaging about $13,780 compared to $8,556 for laparoscopic surgery, and it does not provide additional benefits in terms of surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of robotic reduced-port and laparoscopic approaches for left-sided colorectal cancer surgery. Wei, PL., Huang, YJ., Wang, W., et al.[2023]

Robotic-assisted surgery for colorectal cancer showed a higher rate of intracorporeal anastomosis in right-sided resections compared to conventional laparoscopic surgery, indicating a potential advantage in surgical technique.

Despite longer operative times for robotic surgery, it resulted in fewer conversions to open surgery and demonstrated similar postoperative morbidity and oncological outcomes, suggesting it is a safe and effective alternative to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Robotic Assisted Colorectal Cancer Surgery Equivalent Compared to Laparoscopic Procedures during the Introduction of a Robotic Program? A Propensity-Score Matched Analysis. Tschann, P., Weigl, MP., Lechner, D., et al.[2022]

A review of 77 studies involving 3,145 robotic colorectal surgeries highlights the importance of proper port placement, showing that efficient surgeries can be performed without moving the patient cart, depending on the type of procedure and robotic system used.

The use of the da Vinci Xi robotic system allows for a simplified port configuration, and recent techniques like the single-docking method enhance the flexibility and efficiency of robotic surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic surgery for colorectal disease: review of current port placement and future perspectives. Lee, JL., Alsaleem, HA., Kim, JC.[2022]

Robotic colorectal surgery (RCcR) can be safely implemented in a high-volume center, showing no conversions to open surgery and fewer complications (16.6%) compared to non-robotic procedures (25%).

Short-term outcomes, including estimated blood loss and length of hospital stay, were improved in the RCcR group, with comparable oncological results to traditional methods, indicating that robotic techniques can be effectively integrated into surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective implementation and adaptation of structured robotic colorectal programme in a busy tertiary unit. Thomas, A., Altaf, K., Sochorova, D., et al.[2022]

Robotic colorectal surgery is as safe and effective as traditional laparoscopic surgery, based on a systematic review of 17 studies involving 4,342 patients.

However, robotic procedures take longer to perform (about 39 minutes more) and have a higher likelihood of being converted to open surgery, indicating some limitations that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic versus laparoscopic colorectal surgery. Trinh, BB., Jackson, NR., Hauch, AT., et al.[2020]

The study demonstrated that reduced-port robotic surgery (RPRS) for left-sided colon cancer resulted in a significantly shorter operative time compared to conventional multi-port robotic surgery (MPRS), with mean times of 258 minutes versus 319 minutes.

RPRS also provided a cosmetic advantage with a smaller total incision length (38 mm) compared to MPRS (83 mm), while maintaining similar postoperative outcomes such as diet tolerance, pain scores, and complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Colectomy for Left-Sided Colon Cancer: Comparison of Reduced-Port and Conventional Multi-Port Robotic Surgery. Bae, SU., Jeong, WK., Baek, SK.[2018]

References

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

Learning curve for single-port robot-assisted colectomy. [2022]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Reduced-port robotic anterior resection for left-sided colon cancer using the Da Vinci single-site(®) platform. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of robotic reduced-port and laparoscopic approaches for left-sided colorectal cancer surgery. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Is Robotic Assisted Colorectal Cancer Surgery Equivalent Compared to Laparoscopic Procedures during the Introduction of a Robotic Program? A Propensity-Score Matched Analysis. [2022]

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

Robotic surgery for colorectal disease: review of current port placement and future perspectives. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effective implementation and adaptation of structured robotic colorectal programme in a busy tertiary unit. [2022]

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

Robotic versus laparoscopic colorectal surgery. [2020]

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

Robot-Assisted Colectomy for Left-Sided Colon Cancer: Comparison of Reduced-Port and Conventional Multi-Port Robotic Surgery. [2018]