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

NCT05457244 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CGMH-SP2021-4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Neoplasms

Keywords

Colorectal Cancer; Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Perioperative Parameters:Incision length

  immediately after the surgery

• Perioperative Parameters:Time of surgery

  immediately after the surgery

• Perioperative Parameters:Total operative time

  immediately after the surgery

• Perioperative Parameters:Robotic console time

  immediately after the surgery

• Perioperative Parameters: Blood transfusions

  immediately after the surgery

Study Arms (1)

Participant arm

EXPERIMENTAL

Device: single-port robotic surgery

Interventions

single-port robotic surgery DEVICE

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.

Also known as: da Vinci SP System

Participant arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Intuitive Surgical: collaborator

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 28707106 RESULT

• 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.

  PMID: 32394173 RESULT

• 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.

  PMID: 24117036 RESULT

• 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: 10.1111/j.1463-1318.2011.02825.x.

  PMID: 21914101 RESULT

• 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.2014.0167. Epub 2014 Jul 31.

  PMID: 25079975 RESULT

• 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.2016.07.008. Epub 2016 Aug 31.

  PMID: 27592126 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Chien-Chang Lu, MD

  Kaohsiung Chang Gung Memorial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 13, 2022
• Study Start: September 1, 2023
• Primary Completion: June 19, 2024
• Study Completion: December 31, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)