Robot-Assisted Surgery for Surgical Procedures

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Disqualifiers: BMI > 45, COPD, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a robotic system for abdominal and pelvic surgeries. It targets patients needing these surgeries because the robot can make precise movements through a small cut, resulting in less pain and quicker recovery.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 idea that Robot-Assisted Surgery for Surgical Procedures is an effective treatment?

The available research shows that the da Vinci Single Port Robotic System is effective for various surgical procedures. For instance, in a study on prostate surgery, the system was used on 23 patients, and the results were promising. The average surgery time was about 236 minutes, with minimal blood loss and a short hospital stay of just one day. Importantly, there were no unexpected complications or need to switch to traditional surgery methods. This suggests that the system is safe and efficient compared to other surgical options. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment da Vinci Single Port Robotic System?

The da Vinci Single Port Robotic System has been shown to be effective in various surgical procedures, such as right colectomy (removal of part of the colon), transanal minimally invasive surgery for rectal growths, and prostate surgery. Studies report that it is safe and feasible, with minimal blood loss and short hospital stays, indicating its effectiveness in performing complex surgeries through a single incision. ^{1 2 3 4 5}

What safety data exists for robot-assisted surgery using the da Vinci SP system?

The da Vinci SP system has been evaluated in various studies for its safety and performance in single-port robotic surgeries. Initial clinical experiences and results from studies involving right colectomy and colorectal procedures indicate that the system is designed to overcome challenges of traditional robotic and laparoscopic surgeries. The platform has been approved for use in urology, with studies reporting on surgical techniques and perioperative outcomes. While the studies provide initial safety data, they often involve small sample sizes and focus on specific procedures. ^{1 3 6 7 8}

Is the da Vinci Single Port Robotic System safe for use in surgeries?

The da Vinci Single Port Robotic System has been used in various surgeries, including colorectal and urological procedures, with studies focusing on its safety and performance. Initial results suggest it is generally safe, but as with any surgical procedure, there are potential risks and complications that should be discussed with your healthcare provider. ^{1 3 6 7 8}

Is the da Vinci Single Port Robotic System a promising treatment for surgeries?

Yes, the da Vinci Single Port Robotic System is promising because it allows for minimally invasive surgeries with a single incision, which can lead to quicker recovery times and less pain for patients. It has been successfully used in various surgeries, such as prostate and rectal surgeries, showing its versatility and effectiveness. ^{1 2 3 4 8}

How is the da Vinci Single Port Robotic System treatment different from other surgical treatments?

The da Vinci Single Port Robotic System is unique because it allows for surgery through a single small incision, using a flexible camera and articulating instruments for precise movements, which can lead to less scarring and quicker recovery compared to traditional multi-port surgeries. ^{1 2 3 4 8}

Research Team

Mehdi Moslemi-Kebria

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults over 18 who are scheduled for robot-assisted abdominal or pelvic surgery and have consented to participate. It's not suitable for individuals with a BMI over 45, those who've had unsuccessful minimally invasive surgeries before, or have conditions that make such surgeries risky like severe lung disorders.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures

Exclusion Criteria

Body mass index (BMI) > 45

You have had previous abdominal or pelvic surgery that was not minimally invasive and was unsuccessful.

You have a lung condition called chronic obstructive pulmonary disorder that makes minimally invasive surgery unsafe for you.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Patients undergo surgery using the da Vinci SP1098 robotic system

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

• da Vinci Single Port Robotic System

Trial Overview The study is testing the da Vinci SP1098 robotic device in performing less invasive abdominal and pelvic surgeries through a single small incision. The goal is to see if it leads to less pain, fewer complications, and faster recovery compared to traditional methods.

Participant Groups

Group I: Device feasibility (da Vinci SP1098 robotic system) Experimental Treatment 1 Intervention

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

da Vinci Single Port Robotic System is already approved in United States, European Union for the following indications:

Approved in United States as da Vinci SP for:

• Urological procedures (e.g., prostatectomies, nephrectomies, cystectomies)
• Transoral otolaryngology procedures (e.g., lateral oropharyngectomy, tongue base resection)

Approved in European Union as da Vinci SP for:

• Not specified in provided sources, but generally used for urological and otolaryngology procedures

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

The initial experience with the da Vinci Single-Port robotic system for transanal minimally invasive surgery (SP rTAMIS) showed that it is a safe and feasible method for excising rectal neoplasms, with no intraoperative complications reported in two patients.

Both patients successfully underwent full-thickness excisions of rectal lesions without any blood loss, and they were able to resume a liquid diet on the same day of surgery, indicating a quick recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First clinical experience with single-port robotic transanal minimally invasive surgery (SP rTAMIS) for benign rectal neoplasms. Marks, JH., Kunkel, E., Salem, JF., et al.[2021]

The da Vinci SP system allows for successful single-port robotic urologic surgeries in 120 patients, demonstrating its efficacy without the need to convert to other surgical approaches.

The surgeries were performed safely, with only two cases experiencing Clavien-Dindo grade III complications, indicating a low rate of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique and perioperative outcomes of single-port robotic surgery using the da Vinci SP platform in urology. Kim, KH., Ahn, HK., Kim, M., et al.[2022]

The da Vinci single port robotic system has been successfully used for radical robotic-assisted laparoscopic prostatectomy (SP-RALP) in 23 patients, demonstrating its safety and feasibility with no conversions to open surgery.

The procedure had a median operative time of 236 minutes, minimal blood loss of 50 mL, and a short hospital stay of just 1 day, indicating effective outcomes for patients undergoing this innovative surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single port robotic radical prostatectomy with the da Vinci SP platform: a step by step approach. Jones, R., Dobbs, RW., Halgrimson, WR., et al.[2021]

The da Vinci SP robotic surgical system has been found to be safe and feasible for various urological procedures, according to multiple case series, although high-quality studies are still lacking.

The high cost and learning curve associated with the SP system may limit its adoption in healthcare settings, but advancements from other robotic systems could potentially reduce costs and increase usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Port Robotic Surgery in Urology. Garbens, A., Morgan, T., Cadeddu, JA.[2022]

The da Vinci single-port robotic system is the latest technology approved for urological procedures, offering new capabilities for surgeons.

The article discusses common challenges faced during its use at the University of Illinois at Chicago and provides practical solutions to enhance its effectiveness in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Port Robotic Surgery: General Principles and Troubleshooting. Lai, A., Chen, GL., di Meo, NA., et al.[2022]

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 da Vinci Single-Port (SP) platform is a new robotic surgical system that allows for major urological operations to be performed through a single incision, demonstrating technical feasibility in initial clinical experiences from December 2018 to April 2019.

While the SP platform shows promise for minimally invasive surgery, further multi-center studies and randomized trials are necessary to fully understand its role and compare its outcomes to traditional multi-port robotic systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robotic surgery: the next generation of minimally invasive urology. Dobbs, RW., Halgrimson, WR., Talamini, S., et al.[2021]

References

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

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

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

First clinical experience with single-port robotic transanal minimally invasive surgery (SP rTAMIS) for benign rectal neoplasms. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Technique and perioperative outcomes of single-port robotic surgery using the da Vinci SP platform in urology. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Single port robotic radical prostatectomy with the da Vinci SP platform: a step by step approach. [2021]

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

Single Port Robotic Surgery in Urology. [2022]

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

Single-Port Robotic Surgery: General Principles and Troubleshooting. [2022]

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

Single-port robotic surgery: the next generation of minimally invasive urology. [2021]