Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery

Surgery Clinical Trial

— STARS-CC02  

Official title:

Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04843189
• Other study ID #: STARS-CC02
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2021
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 648
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age: 18-80 years old, male or female;

2. Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;

3. The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;

5. 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.

Exclusion Criteria:

1. Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;

2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;

3. Neighboring organs need to be combined with organ resection;

4. New adjuvant therapy before surgery;

5. ASA grade = grade IV and/or ECOG physical status score> 2 points;

6. Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;

7. Have a history of severe mental illness;

8. Pregnant or lactating women;

9. Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Da Vinci Robot
• Surgery

Intervention

Procedure:
• Da Vinci Robotic Surgery
Da Vinci Robotic Surgery

Locations

Country	Name	City	State
China	Jilin University First Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lymph nodes harvested	Number of lymph nodes harvested	During the operation
Secondary	Operation time	Operation time	During the operation
Secondary	Length of surgical incision	Length of surgical incision	During the operation
Secondary	Intraoperative blood loss	Intraoperative blood loss	During the operation
Secondary	Intraoperative concversion rate	Intraoperative concversion rate	During the operation
Secondary	Postoperative recovery	first exhaust, defecation time, restoring liquid diet, hospitalization days, etc.	During the postoperative hospital stay
Secondary	3-year disease-free survival	3-year disease-free survival	3 years after surgery
Secondary	5-year overall survival	5-year overall survival	5 years after surgery