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NCT Number: NCT05457244

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: da Vinci SP System

Primary outcomes

  1. Success rate (%)

    Time frame: 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 outcomes

  1. Perioperative Parameters:Incision length

    Time frame: immediately after the surgery

    Incision length

  2. Perioperative Parameters:Time of surgery

    Time frame: immediately after the surgery

    Time of surgery

  3. Perioperative Parameters:Total operative time

    Time frame: immediately after the surgery

    Total operative time

  4. Perioperative Parameters:Robotic console time

    Time frame: immediately after the surgery

    Robotic console time

  5. Perioperative Parameters: Blood transfusions

    Time frame: immediately after the surgery

    Blood transfusion amount

  6. Perioperative Parameters: Estimated blood loss

    Time frame: immediately after the surgery

    Estimated blood loss

  7. Perioperative Parameters: Intra-operative Complications

    Time frame: immediately after the surgery

    Satava System

  8. Perioperative Parameters: Urine output

    Time frame: immediately after the surgery

    Urine output

  9. Perioperative Parameters: Type of anastomosis

    Time frame: immediately after the surgery

    How the anastomosis was performed and method of construction

  10. Postoperative Parameters:pain requirements

    Time frame: Within 30days after the surgery

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

  11. Postoperative Parameters:Pain score

    Time frame: Within 30days after the surgery

    NRS

  12. Postoperative Parameters:Time to tolerate diets

    Time frame: Within 30days after the surgery

    time to tolerate clear liquids and solid food

  13. Postoperative Parameters:Time to flatus

    Time frame: Within 30days after the surgery

    Time to flatus

  14. Postoperative Parameters:Time to discharge

    Time frame: Within 30days after the surgery

    Time to discharge

  15. Postoperative Parameters:Complications

    Time frame: Within 30days after the surgery

    Clavien-Dindo Classification

  16. Postoperative Parameters:Readmission and reoperation rate

    Time frame: Within 30days after the surgery

    Readmission and reoperation rate

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Intuitive Surgical

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 13, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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