the Ethics Committee of the First Affiliated Hospital of Nanchang University
Conditions: Robotic, Laparoscopic, Colon Cancer, Long-term Outcomes, Short-term Outcomes
Sponsor: Taiyuan Li

 
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt
Release Date: May 29, 2024
ClinicalTrials.gov ID: [Not yet assigned]
 
Study Identification
Unique Protocol ID: IIT2023015
Brief Title: Comparison of Short-term and Long-term Outcomes of Robotic and
Laparoscopic Right Colon Cancer: a 10-year Single-center Large-sample
Retrospective Study
Official Title: the Ethics Committee of the First Affiliated Hospital of Nanchang University
Secondary IDs:
Study Status
Record Verification: May 2024
Overall Status: Completed
Study Start: December 1, 2014 [Actual]
Primary Completion: March 31, 2024 [Actual]
Study Completion: April 30, 2024 [Actual]
Sponsor/Collaborators
Sponsor: Taiyuan Li
Responsible Party: Sponsor-Investigator
Investigator: Taiyuan Li [tli]
Official Title: the First Affiliated Hospital of Nanchang University
Affiliation: Nanchang University
Collaborators:
Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
U.S. FDA IND/IDE: No
Human Subjects Review: Board Status: Exempt
Data Monitoring:
Study Description
Brief Summary: The goal of this observational study is to evaluate the short-term outcomes and
long-term outcomes of robot-assisted right colon group for cancer compared
-  Page 1 of 4  -

to laparoscopic-assisted right colon group. This is a large sample study based
on ten years of clinical data. The main question it aims to answer is: What are
the advantages of da Vinci robot right hemicolectomy compared to laparoscopic
right hemicolectomy, and is there a difference in long-term efficacy between the
two methods.
Detailed Description:
Conditions
Conditions: Robotic, Laparoscopic, Colon Cancer, Short-term Outcomes, Long-term
Outcomes
Keywords:
Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 1879 [Actual]
Number of Groups/Cohorts: 2
Groups and Interventions
Groups/Cohorts
Interventions
robot-assisted right colon group
Robot assisted radical surgery for right colon cancer
Device: Da Vinci Robot Surgical
System
Performing surgery on right colon
cancer patients using the da
Vinci robotic surgical system or
laparoscopic surgical system
Other Names:
•  Laparoscopic surgical system
laparoscopic-assisted right colon group
Laparoscopic assisted radical surgery for right colon cancer
Device: Da Vinci Robot Surgical
System
Performing surgery on right colon
cancer patients using the da
Vinci robotic surgical system or
laparoscopic surgical system
Other Names:
•  Laparoscopic surgical system
Outcome Measures
Primary Outcome Measure:
1.  overall survival
[Time Frame: months]
2.  disease-free survival
-  Page 2 of 4  -

[Time Frame: months]
Secondary Outcome Measure:
3.  the rate of postoperative complications
[Time Frame: rates]
4.  operative time
[Time Frame: minute]
5.  estimation of blood loss
[Time Frame: ml]
6.  number of retrieved lymph nodes
[Time Frame: Number]
7.  days after postoperative hospital stay
[Time Frame: day]
8.  time to first exhaust
[Time Frame: hours]
9.  time to liquid diet
[Time Frame: hours]
10.  the rate of intracorporeal anastomosis
[Time Frame: rates]
Eligibility
Study Population: The consecutive cases of robotic-assisted or laparoscopic-assisted right
colectomy between December 2014 and March 2024. All cases derived from
the First Affiliated Hospital of Nanchang University.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria: Inclusion Criteria:1) age: 18-85 years; 2) no distant metastasis; 3) preoperative
colonoscopy showing that the tumor was located in the ileocecal region,
ascending colon, hepatic flexure, or transverse colon with pathology showing
malignancy; 4) signed informed consent.
-
Exclusion Criteria:1) multiple primary colorectal cancer; 2) recurrent right colon
cancer; 3) preoperative neoadjuvant chemotherapy; 4) emergency surgery for
intestinal obstruction, bleeding or perforation; 5) incomplete data and missing
follow-up data.
-
Contacts/Locations
Central Contact Person: Taiyuan Li, doctor
Email: ndyfy00530@ncu.edu.cn
Central Contact Backup: shanping Ye, doctor
-  Page 3 of 4  -

Email: ndyfy08807@ncu.edu.cn
Study Officials:
Locations:
IPDSharing
Plan to Share IPD: Undecided
Access to the database can be obtained from the corresponding author on
reasonable request.
References
Citations:
Links:
Available IPD/Information:
U.S. National Library of Medicine  |  U.S. National Institutes of Health  |  U.S. Department of Health & Human Services
-  Page 4 of 4  -