Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures

Colorectal Neoplasms Clinical Trial

Official title:

A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457244
• Other study ID #: CGMH-SP2021-4
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Chang Gung Memorial Hospital
• Contact: Chien-Chang Lu, MD
• Phone: +886975056226
• Email: cclu999[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this report on the outcomes, and notably answer questions to demonstrate the performance and safety of this surgical option.

All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Pathological confirm of colon or rectal cancer

• Clinical stage I-III

• Patient is a candidate for minimally invasive right hemicolectomy or anterior resection.

• ASA =3

• Performance status: ECOG 0-1

Exclusion Criteria:

• Emergency surgery

• Patient has metastatic disease

• Patient has a bleeding or clotting disorder

• Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements

• Previous laparotomy history

• Patient unable to provide informed consent

• Patient is pregnant

• BMI 35.0 or higher

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• single-port robotic surgery
Colorectal surgery using the da Vinci SP System will be performed via the umbilicus, McBurney's site or the reverse McBurney's site depending on the sites of lesion. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Intuitive Surgical

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Kim SJ, Choi BJ, Lee SC. Comparative analysis of outcomes after multiport and single-port laparoscopic colectomy in emergency situations: Is single-port laparoscopic colectomy safe and feasible? Asian J Surg. 2018 Jan;41(1):20-29. doi: 10.1016/j.asjsur.20 — View Citation

Kneist W, Stein H, Rheinwald M. Da Vinci Single-Port robot-assisted transanal mesorectal excision: a promising preclinical experience. Surg Endosc. 2020 Jul;34(7):3232-3235. doi: 10.1007/s00464-020-07444-4. Epub 2020 May 11. — View Citation

Lai WH, Lin YM, Lee KC, Chen HH, Chen YJ, Lu CC. The application of McBurney's single-incision laparoscopic colectomy alleviates the response of patients to postoperative wound pain. J Laparoendosc Adv Surg Tech A. 2014 Sep;24(9):606-11. doi: 10.1089/lap. — View Citation

Lin YM, Chen HH, Chen YJ, Chen PH, Lu CC. Single-incision laparoscopic colectomy using self-made glove port for benign colon diseases. J Laparoendosc Adv Surg Tech A. 2013 Nov;23(11):932-7. doi: 10.1089/lap.2013.0383. Epub 2013 Oct 11. — View Citation

Lu CC, Lin SE, Chung KC, Rau KM. Comparison of clinical outcome of single-incision laparoscopic surgery using a simplified access system with conventional laparoscopic surgery for malignant colorectal disease. Colorectal Dis. 2012 Apr;14(4):e171-6. doi: 1 — View Citation

Marks J, Ng S, Mak T. Robotic transanal surgery (RTAS) with utilization of a next-generation single-port system: a cadaveric feasibility study. Tech Coloproctol. 2017 Jul;21(7):541-545. doi: 10.1007/s10151-017-1655-3. Epub 2017 Jul 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate (%)	Calculating the percentage of cases successfully performed using the da Vinci SP system via the SP access port with or without an additional 12mm assistant port. Conversion to laparoscopy or laparotomy will be considered as failure.	immediately after the surgery
Secondary	Perioperative Parameters:Incision length	Incision length	immediately after the surgery
Secondary	Perioperative Parameters:Time of surgery	Time of surgery	immediately after the surgery
Secondary	Perioperative Parameters:Total operative time	Total operative time	immediately after the surgery
Secondary	Perioperative Parameters:Robotic console time	Robotic console time	immediately after the surgery
Secondary	Perioperative Parameters: Blood transfusions	Blood transfusion amount	immediately after the surgery
Secondary	Perioperative Parameters: Estimated blood loss	Estimated blood loss	immediately after the surgery
Secondary	Perioperative Parameters: Intra-operative Complications	Satava System	immediately after the surgery
Secondary	Perioperative Parameters: Urine output	Urine output	immediately after the surgery
Secondary	Perioperative Parameters: Type of anastomosis	How the anastomosis was performed and method of construction	immediately after the surgery
Secondary	Postoperative Parameters:pain requirements	type, frequency, total amount of narcotics used postoperatively per day	Within 30days after the surgery
Secondary	Postoperative Parameters:Pain score	NRS	Within 30days after the surgery
Secondary	Postoperative Parameters:Time to tolerate diets	time to tolerate clear liquids and solid food	Within 30days after the surgery
Secondary	Postoperative Parameters:Time to flatus	Time to flatus	Within 30days after the surgery
Secondary	Postoperative Parameters:Time to discharge	Time to discharge	Within 30days after the surgery
Secondary	Postoperative Parameters:Complications	Clavien-Dindo Classification	Within 30days after the surgery
Secondary	Postoperative Parameters:Readmission and reoperation rate	Readmission and reoperation rate	Within 30days after the surgery