Prospective Registration Study of Totally Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
STARS-CC01
1 other identifier
observational
650
1 country
1
Brief Summary
This is a comparison of totally laparoscopic and laparoscopic-assisted colon cancer resection, a prospective registration study comparing the safety and benefits of the two operations
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
Typical duration for all trials
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 21, 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 30, 2023
CompletedApril 21, 2021
April 1, 2021
2 years
April 6, 2021
April 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative complications
Complication incidence 30 days after operation
30 days after operation
Secondary Outcomes (9)
Operation time
one hour after surgery
number of lymphnodes dissected
During the operation
Length of surgical incision
one week after surgery
Intraoperative blood loss
one hour after surgery
Intraoperative conversion rate
one hour after surgery
- +4 more secondary outcomes
Study Arms (2)
Totally laparoscopic colon surgery
Totally laparoscopic colon surgery/intracorporeal anastomosis
Laparoscopic-assited colon surgery
Laparoscopic-assited colon surgery/extracorporeal anastomosis
Interventions
intracorporeal anastomosis
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;
- 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)
Central Study Contacts
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 21, 2021
Study Start
May 1, 2021
Primary Completion
May 1, 2023
Study Completion
May 30, 2023
Last Updated
April 21, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share