Robotic Surgery for Gallbladder Conditions

Overseen By Daniel Robledo, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Pregnancy, BMI > 26, 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: 4

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.

Do I need to stop my current medications for the trial?

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 Single-Port Robotic Surgical System for gallbladder conditions?

Research shows that the da Vinci SP robotic system is safe and effective for gallbladder surgery, with benefits like improved surgeon dexterity and minimal blood loss. Patients experienced quick recovery, with most not needing strong pain medication after surgery. ^{1 2 3 4 5}

Is robotic surgery using the da Vinci SP system safe for gallbladder conditions?

Research shows that the da Vinci SP robotic system is generally safe for gallbladder surgery. In studies, patients experienced minimal blood loss, no significant complications, and quick recovery times, indicating a good safety profile. ^{1 2 3 4 6}

How is the da Vinci SP Single-Port Robotic Surgical System treatment different from other treatments for gallbladder conditions?

The da Vinci SP Single-Port Robotic Surgical System is unique because it uses a single small incision through the belly button, allowing for less visible scarring and potentially quicker recovery. It features advanced robotic instruments with wrist-like movement, providing the surgeon with enhanced precision and dexterity compared to traditional multi-port laparoscopic surgery. ^{2 3 4 5 7}

Research Team

Sharona Ross, MD

Principal Investigator

AdventHealth

Eligibility Criteria

This trial is for individuals needing surgery for certain conditions of the liver, pancreas, gallbladder, stomach, and esophagus. It's not clear what specific criteria must be met or who can't participate without more detailed inclusion and exclusion information.

Inclusion Criteria

I am 18-80 years old, with a BMI of 26 or less, and have a benign condition needing gallbladder surgery.

I am 18-80 years old, with GERD or hiatal hernia, a BMI ≤ 26, and in good health.

I am 18-80 years old, with a BMI ≤ 26, ASA ≤ 3, and have a pancreatic condition without spread or vascular involvement.

Exclusion Criteria

I do not require emergency surgery, am not pregnant or nursing, have a BMI ≤ 26, have not had previous abdominal surgery, can consent, and am cleared for general anesthesia and minimally invasive surgery.

I am not pregnant, have a BMI ≤ 26, and can consent. I haven't had previous abdominal surgery and am fit for surgery.

I need an urgent gallbladder removal but I'm not pregnant, nursing, overweight, or have had previous abdominal surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Operative

Assessment of patient fitness using ASA Physical Status Score and Charlson Comorbidity Index Score

1 week

1 visit (in-person)

Surgery

Participants undergo the planned da Vinci SP-assisted operation

Intraoperative

1 visit (in-person)

Post-Operative

Monitoring of intraoperative and post-operative adverse events and complications

10 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after surgery, including 30-day complications and readmission

2 months

2 visits (in-person)

Long-term Follow-up

Assessment of survival, disease recurrence, and long-term adverse events

Annually through year 5

Treatment Details

Interventions

• da Vinci SP® Single-Port Robotic Surgical System

Trial Overview The study is testing the da Vinci SP Surgical System in various surgeries like gallbladder removal and stomach surgery to see how safe it is and how well it works.

Participant Groups

Group I: da Vinci SP® Single-Port Robotic Surgical System Experimental Treatment 1 Intervention

This study will be separated into four stages, depending on the condition the participant is diagnosed with. Each Participant will go through (1) one operation. Stage One will include five (5) subjects who undergo cholecystectomy and five (5) subjects who undergo hiatal hernia repair with fundoplication (Nissen or Toupet) for a total of ten (10) subjects. Stage Two will include five (5) subjects who undergo gastrectomy and five (5) subjects who undergo distal pancreatectomy for a total of ten (10) subjects. Stage Three will include five (5) subjects who undergo pancreaticoduodenectomy and five (5) subjects who undergo esophagectomy for a total of ten (10) subjects. Stage Four will include five (5) subjects who undergo hepatectomy

da Vinci SP® Single-Port Robotic 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 prostate and kidney surgery)
• Lateral oropharyngectomy procedures (radical tonsillectomy)
• Tongue base resection
• Simple prostatectomy
• Radical prostatectomy

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Findings from Research

The first robotic single-site cholecystectomy using the da Vinci SP system was successfully performed on a 59-year-old female patient, demonstrating the system's safety and technical feasibility with no significant intraoperative events.

The operation took 89 minutes with a quick docking time of 6 minutes, highlighting the efficiency of the da Vinci SP system, although the lack of an assistant port may limit its use in more complex surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical feasibility of da Vinci SP single-port robotic cholecystectomy: a case report. Cruz, CJ., Yang, HY., Kang, I., et al.[2020]

The da Vinci SP robotic surgical system demonstrated improved perioperative outcomes in robotic single-site cholecystectomy, with significantly shorter operation, docking, and dissection times compared to the Si-robotic system, indicating enhanced efficiency.

Patients undergoing robotic single-site cholecystectomy with the da Vinci SP system experienced less immediate postoperative pain and shorter hospital stays, suggesting that this method is not only safe but also effective for gallbladder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experiences of robotic SP cholecystectomy: a comparative analysis with robotic Si single-site cholecystectomy. Cruz, CJ., Huynh, F., Kang, I., et al.[2023]

The da Vinci single port robotic platform for cholecystectomy in adolescents demonstrated safety and efficacy, with no fatalities or returns to the operating room among the 7 patients studied, and a low mean estimated blood loss of only 2 mL.

The use of wristed instruments allowed for improved surgeon dexterity, and the single umbilical incision provided excellent cosmetic results, making this approach promising for pediatric robotic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the da Vinci Single Port Robotic Platform on Cholecystectomy in Adolescents. Klazura, G., Graf, A., Sims, T., et al.[2022]

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]

In a study involving 10 patients with gallbladder disease, robotic single-port cholecystectomy using the da Vinci system was successfully completed in 9 out of 10 cases, demonstrating its feasibility.

The average operating time for robotic surgery (105.3 minutes) was comparable to traditional multiport laparoscopic cholecystectomy (106.1 minutes), and there were no serious complications reported, indicating a safe alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robotic cholecystectomy: results from a first human use clinical study of the new da Vinci single-site surgical platform. Wren, SM., Curet, MJ.[2011]

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]

In a study involving 31 women with benign gynecologic diseases, robotic single-port surgery using the da Vinci® SP system was performed successfully with no major complications or need for conversion to traditional laparoscopic methods.

The procedure demonstrated favorable operative outcomes, including a mean operating time of 126.3 minutes and a hospitalization duration of 4.6 days, suggesting it could be a safe and effective alternative for treating various benign gynecologic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic single-port surgery using the da Vinci SP® surgical system for benign gynecologic disease: A preliminary report. Shin, HJ., Yoo, HK., Lee, JH., et al.[2020]

References

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

Technical feasibility of da Vinci SP single-port robotic cholecystectomy: a case report. [2020]

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

Initial experiences of robotic SP cholecystectomy: a comparative analysis with robotic Si single-site cholecystectomy. [2023]

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

Assessment of the da Vinci Single Port Robotic Platform on Cholecystectomy in Adolescents. [2022]

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

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

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

Single-port robotic cholecystectomy: results from a first human use clinical study of the new da Vinci single-site surgical platform. [2011]

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

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

7. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Robotic single-port surgery using the da Vinci SP® surgical system for benign gynecologic disease: A preliminary report. [2020]