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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new surgical method for colorectal cancer using a single-port robotic system. The focus is on determining whether this single-port method is safe and effective compared to current multiport robotic surgeries. The trial seeks participants diagnosed with colorectal issues requiring robotic surgery. Participants should be in good general health and able to give consent. As an unphased trial, this study offers participants the opportunity to contribute to innovative surgical advancements.

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 this single port robotic surgical procedure is safe for colorectal surgery?

Research on single-port robotic surgery for colorectal cancer has shown it to be a safe option. One review found that the Da Vinci Single-Port system is practical and safe for colorectal surgeries. Another study noted promising short-term results in health and cancer treatment, indicating its current effectiveness and safety. The FDA has already approved this system for other surgeries, such as those for the head, neck, and urinary system, which bolsters confidence in its safety for colorectal procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the single port robotic surgery for colorectal cancer because it offers a less invasive alternative to traditional multi-port laparoscopic and open surgeries. This innovative technique uses the Intuitive Da Vinci Single Port SP system, allowing surgeons to perform the entire procedure through a single small incision. This can potentially lead to less pain and quicker recovery times for patients. By minimizing the number of incisions, there's also a reduced risk of complications like infections, making it a promising advancement in colorectal cancer treatment.

What evidence suggests that the Single Port Robotic Surgery is effective for colorectal cancer?

Research shows that the Da Vinci Single-Port (SP) robotic system holds promise for colorectal cancer surgery. Studies have found that this system is safe and effective, leading to good short-term results. Participants in this trial will undergo the colorectal surgical procedure using this system. Previous research indicates that patients experienced positive outcomes without needing to switch to other surgical methods. This technology is already approved for surgeries in other areas, such as the head, neck, and urinary systems, suggesting it could also work well for colorectal cancer. Overall, early evidence indicates it could be a strong option for treating colorectal cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Ankit Sarin, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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

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

Subject is able and willing to provide written informed consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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-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]

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]

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]

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]

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. It achieves high rates of ...

2. link.springer.com link.springer.com/article/10.1007/s00384-025-04878-x

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 Explore studies, robotic surgery research, and clinical outcomes related to da Vinci procedures.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05321134

Evaluation of SINGLE PORT (SP) Robotic Technology in ... This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications. ... Intuitive Da Vinci Single Port SP system.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468900925000684

Comparison of outcomes in robot-assisted colon cancer ... The mean age was 66.8 years and 68.9% of patients underwent surgery for colon cancer. No conversions occurred in the da Vinci group, whereas 2 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039606023007067

Comparison of the efficacy and safety of single-port versus ... This study compared the short-term outcomes of 2 different robotic systems in performing TME for the treatment of rectal cancer based on the propensity score- ...