- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05210647
Robotic Assisted Colon and Rectal Surgery Prognostic and Outcome Analysis
January 14, 2022 updated by: Taichung Veterans General Hospital
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
291
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
-
-
-
Taichung, Taiwan, 40703
- Taichung Veterans General Hospital
-
-
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- for colon and rectal disease, using conventional laparoscopy and da Vinci Xi robot system.
Exclusion Criteria:
- 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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
conventional laparoscopy surgery
Conventional laparoscopy surgery for colon and rectal disease.
|
|
robot assisted surgery
robotic assisted surgery for colon and rectal disease.
|
by da Vinci Xi
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgical outcomes
Time Frame: 2019.1.1-2022.1.8
|
operation time, blood loss, hospital stay, complication rate.
|
2019.1.1-2022.1.8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2019
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
January 8, 2022
Study Registration Dates
First Submitted
January 14, 2022
First Submitted That Met QC Criteria
January 14, 2022
First Posted (Actual)
January 27, 2022
Study Record Updates
Last Update Posted (Actual)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 14, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- CE21319A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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