Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
November 18, 2024 updated by: Chang Gung Memorial Hospital
A Prospective, Single-Center Investigation of the 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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kaohsiung, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participant arm
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
immediately after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative Parameters:Incision length
Time Frame: immediately after the surgery
|
Incision length
|
immediately after the surgery
|
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Perioperative Parameters:Time of surgery
Time Frame: immediately after the surgery
|
Time of surgery
|
immediately after the surgery
|
|
Perioperative Parameters:Total operative time
Time Frame: immediately after the surgery
|
Total operative time
|
immediately after the surgery
|
|
Perioperative Parameters:Robotic console time
Time Frame: immediately after the surgery
|
Robotic console time
|
immediately after the surgery
|
|
Perioperative Parameters: Blood transfusions
Time Frame: immediately after the surgery
|
Blood transfusion amount
|
immediately after the surgery
|
|
Perioperative Parameters: Estimated blood loss
Time Frame: immediately after the surgery
|
Estimated blood loss
|
immediately after the surgery
|
|
Perioperative Parameters: Intra-operative Complications
Time Frame: immediately after the surgery
|
Satava System
|
immediately after the surgery
|
|
Perioperative Parameters: Urine output
Time Frame: immediately after the surgery
|
Urine output
|
immediately after the surgery
|
|
Perioperative Parameters: Type of anastomosis
Time Frame: immediately after the surgery
|
How the anastomosis was performed and method of construction
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immediately after the surgery
|
|
Postoperative Parameters:pain requirements
Time Frame: Within 30days after the surgery
|
type, frequency, total amount of narcotics used postoperatively per day
|
Within 30days after the surgery
|
|
Postoperative Parameters:Pain score
Time Frame: Within 30days after the surgery
|
NRS
|
Within 30days after the surgery
|
|
Postoperative Parameters:Time to tolerate diets
Time Frame: Within 30days after the surgery
|
time to tolerate clear liquids and solid food
|
Within 30days after the surgery
|
|
Postoperative Parameters:Time to flatus
Time Frame: Within 30days after the surgery
|
Time to flatus
|
Within 30days after the surgery
|
|
Postoperative Parameters:Time to discharge
Time Frame: Within 30days after the surgery
|
Time to discharge
|
Within 30days after the surgery
|
|
Postoperative Parameters:Complications
Time Frame: Within 30days after the surgery
|
Clavien-Dindo Classification
|
Within 30days after the surgery
|
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Postoperative Parameters:Readmission and reoperation rate
Time Frame: Within 30days after the surgery
|
Readmission and reoperation rate
|
Within 30days after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chien-Chang Lu, MD, Kaohsiung Chang Gung Memorial
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
June 19, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
July 11, 2022
First Posted (Actual)
July 13, 2022
Study Record Updates
Last Update Posted (Estimated)
November 20, 2024
Last Update Submitted That Met QC Criteria
November 18, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGMH-SP2021-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.