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Colorectal NeoplasmsNCT05457244

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

A study testing single-port robotic surgery in people with Colorectal Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
single-port robotic surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTaiwan
Study dates
1 Sep 2023to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

Other trials in Taiwan

About this study

Official title: 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

Being tested
single-port robotic surgery
Keywords
Colorectal Cancer, Robotic Surgery
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single-port robotic surgeryDevice

    Also called da Vinci SP System

    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.

Study groups in NCT05457244
Study groupRoleWhat they receive
Participant armExperimentalNot described
Receives: Device: single-port robotic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately after the surgery

Secondary outcomes (16)

  1. Perioperative Parameters:Incision length

    Incision length

    Measured: immediately after the surgery

  2. Perioperative Parameters:Time of surgery

    Time of surgery

    Measured: immediately after the surgery

  3. Perioperative Parameters:Total operative time

    Total operative time

    Measured: immediately after the surgery

  4. Perioperative Parameters:Robotic console time

    Robotic console time

    Measured: immediately after the surgery

  5. Perioperative Parameters: Blood transfusions

    Blood transfusion amount

    Measured: immediately after the surgery

  6. Perioperative Parameters: Estimated blood loss

    Estimated blood loss

    Measured: immediately after the surgery

  7. Perioperative Parameters: Intra-operative Complications

    Satava System

    Measured: immediately after the surgery

  8. Perioperative Parameters: Urine output

    Urine output

    Measured: immediately after the surgery

  9. Perioperative Parameters: Type of anastomosis

    How the anastomosis was performed and method of construction

    Measured: immediately after the surgery

  10. Postoperative Parameters:pain requirements

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

    Measured: Within 30days after the surgery

  11. Postoperative Parameters:Pain score

    NRS

    Measured: Within 30days after the surgery

  12. Postoperative Parameters:Time to tolerate diets

    time to tolerate clear liquids and solid food

    Measured: Within 30days after the surgery

  13. Postoperative Parameters:Time to flatus

    Time to flatus

    Measured: Within 30days after the surgery

  14. Postoperative Parameters:Time to discharge

    Time to discharge

    Measured: Within 30days after the surgery

  15. Postoperative Parameters:Complications

    Clavien-Dindo Classification

    Measured: Within 30days after the surgery

  16. Postoperative Parameters:Readmission and reoperation rate

    Readmission and reoperation rate

    Measured: Within 30days after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start1 Sep 2023
  3. Primary completion19 Jun 2024
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05457244
Sponsor's protocol ID
CGMH-SP2021-4
Status last verified
Nov 2024
First submitted
22 Jun 2022
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 28707106

  • 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.

    PubMed 32394173

  • 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.

    PubMed 24117036

  • 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.

    PubMed 21914101

  • 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.

    PubMed 25079975

  • 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.

    PubMed 27592126

Questions about this trial

What is this clinical trial studying?

A study testing single-port robotic surgery in people with Colorectal Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate (%) (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05457244, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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