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

Primary Purpose

Colorectal Neoplasms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
single-port robotic surgery
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, Robotic Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participant arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Perioperative Parameters:Incision length
Incision length
Perioperative Parameters:Time of surgery
Time of surgery
Perioperative Parameters:Total operative time
Total operative time
Perioperative Parameters:Robotic console time
Robotic console time
Perioperative Parameters: Blood transfusions
Blood transfusion amount
Perioperative Parameters: Estimated blood loss
Estimated blood loss
Perioperative Parameters: Intra-operative Complications
Satava System
Perioperative Parameters: Urine output
Urine output
Perioperative Parameters: Type of anastomosis
How the anastomosis was performed and method of construction
Postoperative Parameters:pain requirements
type, frequency, total amount of narcotics used postoperatively per day
Postoperative Parameters:Pain score
NRS
Postoperative Parameters:Time to tolerate diets
time to tolerate clear liquids and solid food
Postoperative Parameters:Time to flatus
Time to flatus
Postoperative Parameters:Time to discharge
Time to discharge
Postoperative Parameters:Complications
Clavien-Dindo Classification
Postoperative Parameters:Readmission and reoperation rate
Readmission and reoperation rate

Full Information

First Posted
June 22, 2022
Last Updated
July 14, 2022
Sponsor
Chang Gung Memorial Hospital
Collaborators
Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT05457244
Brief Title
Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Official Title
A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Intuitive Surgical

4. Oversight

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
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Cancer, Robotic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participant arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
single-port robotic surgery
Other Intervention Name(s)
da Vinci SP System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success rate (%)
Description
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.
Time Frame
immediately after the surgery
Secondary Outcome Measure Information:
Title
Perioperative Parameters:Incision length
Description
Incision length
Time Frame
immediately after the surgery
Title
Perioperative Parameters:Time of surgery
Description
Time of surgery
Time Frame
immediately after the surgery
Title
Perioperative Parameters:Total operative time
Description
Total operative time
Time Frame
immediately after the surgery
Title
Perioperative Parameters:Robotic console time
Description
Robotic console time
Time Frame
immediately after the surgery
Title
Perioperative Parameters: Blood transfusions
Description
Blood transfusion amount
Time Frame
immediately after the surgery
Title
Perioperative Parameters: Estimated blood loss
Description
Estimated blood loss
Time Frame
immediately after the surgery
Title
Perioperative Parameters: Intra-operative Complications
Description
Satava System
Time Frame
immediately after the surgery
Title
Perioperative Parameters: Urine output
Description
Urine output
Time Frame
immediately after the surgery
Title
Perioperative Parameters: Type of anastomosis
Description
How the anastomosis was performed and method of construction
Time Frame
immediately after the surgery
Title
Postoperative Parameters:pain requirements
Description
type, frequency, total amount of narcotics used postoperatively per day
Time Frame
Within 30days after the surgery
Title
Postoperative Parameters:Pain score
Description
NRS
Time Frame
Within 30days after the surgery
Title
Postoperative Parameters:Time to tolerate diets
Description
time to tolerate clear liquids and solid food
Time Frame
Within 30days after the surgery
Title
Postoperative Parameters:Time to flatus
Description
Time to flatus
Time Frame
Within 30days after the surgery
Title
Postoperative Parameters:Time to discharge
Description
Time to discharge
Time Frame
Within 30days after the surgery
Title
Postoperative Parameters:Complications
Description
Clavien-Dindo Classification
Time Frame
Within 30days after the surgery
Title
Postoperative Parameters:Readmission and reoperation rate
Description
Readmission and reoperation rate
Time Frame
Within 30days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Chang Lu, MD
Phone
+886975056226
Email
cclu999@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Chang Lu, MD
Organizational Affiliation
Kaohsiung Chang Gung Memorial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Chang Lu, MD
Email
cclu999@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28707106
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.
Results Reference
result
PubMed Identifier
32394173
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.
Results Reference
result
PubMed Identifier
24117036
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.
Results Reference
result
PubMed Identifier
21914101
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: 10.1111/j.1463-1318.2011.02825.x.
Results Reference
result
PubMed Identifier
25079975
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.2014.0167. Epub 2014 Jul 31.
Results Reference
result
PubMed Identifier
27592126
Citation
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.
Results Reference
result

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

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