Robotic Surgery for Pediatric Procedures

(SPARCS Trial)

Overseen By Karthik Balakrishnan, MD, MPH, FAAP, FACS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Coagulopathy, ASA 4 or 5, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the da Vinci Xi Robotic Surgery System in children and adolescents. It focuses on various surgeries, such as gallbladder removal or lung resection, using robotic surgery. The trial includes patients aged 6 to 21 who require one of these surgeries and have not previously undergone robotic surgery. As an unphased trial, it provides a unique opportunity for participants to experience cutting-edge robotic surgery technology.

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 Xi Robotic Surgery System is safe for pediatric procedures?

Research has shown that the da Vinci Xi Robotic Surgery System is generally safe for children. One study found that problems with the robotic system occurred in only 2.8% of cases, with a switch to traditional surgery needed in less than 1% of cases. This indicates that most surgeries proceeded smoothly without a change in method. Another study found that robotic surgery caused the least discomfort compared to laparoscopic or open procedures, suggesting that the da Vinci Xi system is well-tolerated. Overall, these findings indicate that the system is safe and can be a comfortable option for many children's surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic surgery for pediatric procedures because it offers enhanced precision and control compared to traditional surgical methods. The da Vinci Xi Robotic Surgery System allows surgeons to perform complex operations through smaller incisions, potentially reducing recovery time and minimizing scarring for young patients. Additionally, the system's advanced 3D visualization and ergonomic design can improve surgical accuracy and outcomes. This technology could revolutionize how pediatric surgeries are performed by providing safer and more effective treatment options for delicate and intricate procedures.

What evidence suggests that the da Vinci Xi Robotic Surgery System is effective for pediatric procedures?

This trial will evaluate the use of the da Vinci Xi Robotic Surgery System for pediatric procedures. Studies have shown that robotic-assisted surgery, such as with the da Vinci Xi system, offers several benefits over traditional open surgery. Patients often experience less pain post-operation, spend less time in the hospital, and recover more quickly. For example, a review of studies found that robotic surgery is increasingly used for children's procedures, demonstrating its growing effectiveness and acceptance. Research also highlights the da Vinci Xi system's precision, which can lead to better surgical outcomes in young patients. Overall, this technology aims to make surgeries safer and more effective for children and teenagers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for pediatric and adolescent patients needing surgeries like gallbladder removal, hysterectomy, or lung surgery. It's not specified who can't join the trial, but typically those with conditions that could complicate surgery or recovery might be excluded.

Inclusion Criteria

Subject or their guardian is willing and able to provide written informed consent

Subject or their guardian is willing and able to comply with the study protocol requirements

My doctor and I have chosen a study procedure as the best treatment for my condition.

Exclusion Criteria

Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent

Subject is pregnant or suspected to be pregnant

I cannot undergo surgery or general anesthesia due to health risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments to prepare for robotic surgery

1-2 weeks

Treatment - Arm 1

Participants undergo robotic surgery for procedures such as Sleeve Gastrectomy, Cholecystectomy, and others

Variable, based on procedure

Treatment - Arm 2

Participants undergo additional robotic surgeries after Arm 1 completion, including Bronchoplasty and other procedures

Variable, based on procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

7 weeks post-operative

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci Xi Robotic Surgery System

Trial Overview The da Vinci Xi Robotic Surgery System is being tested to see if it's safe and works well for various surgeries in young patients. This pilot study by Stanford University will initially assess its feasibility and effectiveness.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Arm 2 will be performed after all patients in Arm 1 have completed their procedures and where additional preclinical performance testing is required, including: Bronchoplasty, Endoscopic Laryngeal/Pharyngeal Suturing, including: Vocal Feminization, Laryngeal Cleft Repair, Endolaryngeal Adjacent Tissue Transfer, Pharyngoplasty; Ileocolonic Resections; Laryngoplasty with or without Graft; Proctectomy with Ileal Pouch-Anal Anastomosis (IPAA)

Group II: Arm 1 Experimental Treatment 1 Intervention

Arm 1 includes procedures to be performed robotically that have an adult model or already established preclinical evidence including: Sleeve Gastrectomy, Cholecystectomy, Splenectomy, Hysterectomy, endometriosis, ureteral re-implant, and cervical and thoracic tracheoplasty, thymectomy, lobectomy/wedge lung resection, lung segmentectomy

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12000270/

Seven years of pediatric robotic-assisted surgery MIS offers several advantages over open surgery, including reduced postoperative pain, shorter hospital stays, faster recovery times, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06671639

Stanford Program to Accelerate Robotic Children's Surgery The goal of this clinical trial is to provide additional data to confirm safety and performance of the da Vinci Xi Surgical System in a human clinical ...

3. wjps.bmj.com wjps.bmj.com/content/5/4/e000482

Application and prospects of robotic surgery in children Efficacy and safety of robotic procedures performed using the dA Vinci robotic surgical system at a single Institute in Korea: experience with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949711624000418

Innovations and progress in robotic pediatric general surgery A systematic review of urological pediatric procedures identified a 236.6 % annual increase per year of case volumes reported in the literature from 2003 to ...

5. childrensnebraska.org childrensnebraska.org/ahead-of-the-curve-davincis-robotic-surgery-genius

Ahead of the Curve: DaVinci's Robotic-Surgery Genius The da Vinci Xi robotic-assisted surgery system brings cutting-edge technology and surgical precision together to transform outcomes for young patients.

6. liebertpub.com liebertpub.com/doi/10.1177/10926429251392856

Implementing the da Vinci SP® Robotic Platform in ... Conclusion: SPRS using the da Vinci SP® system appears technically feasible in carefully selected adolescent patients, with favorable short-term ...