Colorectal DisordersNCT05210647
Robotic Assisted Colon and Rectal Surgery Prognostic and Outcome Analysis
An observational study of Colorectal Disorders, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To analysis surgical outcome between robotic and laparoscopy colon and rectal surgery. Retrospective case-control study of single institute. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- robotic surgery
- Type of treatment
- Medical device
- How many people
- 291 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 8 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From 2019.1.1 to 2022.1.8. Robot surgery team in department of colorectal surgery in TCVGH leaded by Surgeon A and B conducted 142 robot surgery using da Vinci Xi. Meanwhile, they also done 150 conventional laparoscopy surgery. The study compare the surgical outcome and relative prognostic factors between laparoscopy and robotic surgery.
Who may be able to join
- for colon and rectal disease, using conventional laparoscopy and da Vinci Xi robot system.
Who cannot join
- emergent operation, combined other open surgery, for non-colorectal disease, carcinomatosis found to be unsuitable for surgery once peritoneum entered, taTME in laparoscopy group and other robot system in robotic surgery group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Surgical Outcome of Robotic Surgery Versus Conventional Laparoscopy Surgery. Retrospective Case Control Study in Single Institute.
To analysis surgical outcome between robotic and laparoscopy colon and rectal surgery. Retrospective case-control study of single institute.
Read the detailed description
Microinvasive surgery bring minor pain, faster recovery and comparable oncological outcome. Robotic surgery seems to be superior in precise dissection then before. This study compare robot assisted to laparoscopy surgery in colon and rectal disease. To analysis the surgical outcome and prognostic factors.
- Conditions
- Colorectal Disorders
- Being tested
- robotic surgery
- Keywords
- robot, laparopscopy, MIS, surgical outcome, da Vinci Xi,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgeryDevice
by da Vinci Xi
| Study group | Role | What they receive |
|---|---|---|
| conventional laparoscopy surgery | Conventional laparoscopy surgery for colon and rectal disease. | |
| robot assisted surgery | robotic assisted surgery for colon and rectal disease. Receives: Device: robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical outcomes
operation time, blood loss, hospital stay, complication rate.
Measured: 2019.1.1-2022.1.8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2019
- Primary completion31 Jul 2021
- Study completion8 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210647
- Sponsor's protocol ID
- CE21319A
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Surgical Outcome of Robotic Surgery Versus Conventional Laparoscopy Surgery. Retrospective Case Control Study in Single Institute.
- ClinicalTrials.gov ID
- NCT05210647
- Acronym / sponsor ID
- CE21319A
- Conditions
- Colorectal Disorders
- Keywords
- robot, laparopscopy, MIS, surgical outcome, da Vinci Xi,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analysis surgical outcome between robotic and laparoscopy colon and rectal surgery. Retrospective case-control study of single institute.
Detailed description
Microinvasive surgery bring minor pain, faster recovery and comparable oncological outcome. Robotic surgery seems to be superior in precise dissection then before. This study compare robot assisted to laparoscopy surgery in colon and rectal disease. To analysis the surgical outcome and prognostic factors.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional laparoscopy surgery | – | –Conventional laparoscopy surgery for colon and rectal disease. |
| robot assisted surgery | – | Device: robotic surgeryrobotic assisted surgery for colon and rectal disease. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From 2019.1.1 to 2022.1.8. Robot surgery team in department of colorectal surgery in TCVGH leaded by Surgeon A and B conducted 142 robot surgery using da Vinci Xi. Meanwhile, they also done 150 conventional laparoscopy surgery. The study compare the surgical outcome and relative prognostic factors between laparoscopy and robotic surgery.
Key inclusion criteria (1 listed)
- for colon and rectal disease, using conventional laparoscopy and da Vinci Xi robot system.
Key exclusion criteria (1 listed)
- emergent operation, combined other open surgery, for non-colorectal disease, carcinomatosis found to be unsuitable for surgery once peritoneum entered, taTME in laparoscopy group and other robot system in robotic surgery group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic surgeryby da Vinci Xi | Device | robot assisted surgery |
Primary outcome
surgical outcomes
Time frame: 2019.1.1-2022.1.8
operation time, blood loss, hospital stay, complication rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Disorders, run by Taichung Veterans General 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
surgical outcomes (time frame: 2019.1.1-2022.1.8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2022.