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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05457244
Collaborator
Intuitive Surgical (Industry)
30
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: single-port robotic surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participant arm

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.
Other Names:
  • da Vinci SP System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success rate (%) [immediately after the surgery]

      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.

    Secondary Outcome Measures

    1. Perioperative Parameters:Incision length [immediately after the surgery]

      Incision length

    2. Perioperative Parameters:Time of surgery [immediately after the surgery]

      Time of surgery

    3. Perioperative Parameters:Total operative time [immediately after the surgery]

      Total operative time

    4. Perioperative Parameters:Robotic console time [immediately after the surgery]

      Robotic console time

    5. Perioperative Parameters: Blood transfusions [immediately after the surgery]

      Blood transfusion amount

    6. Perioperative Parameters: Estimated blood loss [immediately after the surgery]

      Estimated blood loss

    7. Perioperative Parameters: Intra-operative Complications [immediately after the surgery]

      Satava System

    8. Perioperative Parameters: Urine output [immediately after the surgery]

      Urine output

    9. Perioperative Parameters: Type of anastomosis [immediately after the surgery]

      How the anastomosis was performed and method of construction

    10. Postoperative Parameters:pain requirements [Within 30days after the surgery]

      type, frequency, total amount of narcotics used postoperatively per day

    11. Postoperative Parameters:Pain score [Within 30days after the surgery]

      NRS

    12. Postoperative Parameters:Time to tolerate diets [Within 30days after the surgery]

      time to tolerate clear liquids and solid food

    13. Postoperative Parameters:Time to flatus [Within 30days after the surgery]

      Time to flatus

    14. Postoperative Parameters:Time to discharge [Within 30days after the surgery]

      Time to discharge

    15. Postoperative Parameters:Complications [Within 30days after the surgery]

      Clavien-Dindo Classification

    16. Postoperative Parameters:Readmission and reoperation rate [Within 30days after the surgery]

      Readmission and reoperation rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 833

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital
    • Intuitive Surgical

    Investigators

    • Principal Investigator: Chien-Chang Lu, MD, Kaohsiung Chang Gung Memorial

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05457244
    Other Study ID Numbers:
    • CGMH-SP2021-4
    First Posted:
    Jul 13, 2022
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Chang Gung Memorial Hospital
    Colorectal Cancer
    Robotic Surgery
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jul 15, 2022