Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
STARS-CC02
1 other identifier
observational
648
1 country
1
Brief Summary
The purpose of this study is to compare the clinical data of patients with colon cancer who received robotic or laparoscopic surgery, and to compare the short-term and long-term effects of robotic surgery in the treatment of colon cancer. To verify the safety and effectiveness of the corresponding surgical methods, and provide better guidance for the following clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 13, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedApril 13, 2021
April 1, 2021
2 years
April 6, 2021
April 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of lymph nodes harvested
Number of lymph nodes harvested
During the operation
Secondary Outcomes (7)
Operation time
During the operation
Length of surgical incision
During the operation
Intraoperative blood loss
During the operation
Intraoperative concversion rate
During the operation
Postoperative recovery
During the postoperative hospital stay
- +2 more secondary outcomes
Study Arms (2)
Da Vinci Robotic Surgery Group
Da Vinci Robotic Surgery Group
Laparoscopy-assisted surgery group
Laparoscopy-assisted surgery group
Interventions
Da Vinci Robotic Surgery
Eligibility Criteria
Patients with colon cancer
You may qualify if:
- Age: 18-80 years old, male or female;
- Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;
- The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;
- \. ECOG score 0-2; 6. Heart, lung, liver, and kidney functions can tolerate surgery; 7. Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.
You may not qualify if:
- Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- Neighboring organs need to be combined with organ resection;
- New adjuvant therapy before surgery;
- ASA grade ≥ grade IV and/or ECOG physical status score\> 2 points;
- Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
- Have a history of severe mental illness;
- Pregnant or lactating women;
- Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jilin University First Hospital
Changchun, Jilin, 130021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 13, 2021
Study Start
May 1, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
April 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share