Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery (STARS-CC02)

Jilin University

Status: Unknown

Conditions: Surgery; Colon Cancer; Da Vinci Robot

Treatments: Procedure: Da Vinci Robotic Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04843189

STARS-CC02

Details and patient eligibility

About

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.

Enrollment: 648 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

4. 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.

Trial design

648 participants in 2 patient groups

Da Vinci Robotic Surgery Group

Description:

Da Vinci Robotic Surgery Group

Treatment:

Procedure: Da Vinci Robotic Surgery

Laparoscopy-assisted surgery group

Description:

Laparoscopy-assisted surgery group

Treatment:

Procedure: Da Vinci Robotic Surgery