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

NCT ID: NCT04843189

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 648 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-05-01

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.

Conditions

Da Vinci Robot; Colon Cancer; Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Da Vinci Robotic Surgery Group

Da Vinci Robotic Surgery Group

Da Vinci Robotic Surgery

Intervention Type: PROCEDURE

Da Vinci Robotic Surgery

Laparoscopy-assisted surgery group

Laparoscopy-assisted surgery group

Da Vinci Robotic Surgery

Intervention Type: PROCEDURE

Da Vinci Robotic Surgery

Interventions

Da Vinci Robotic Surgery

Da Vinci Robotic Surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Quan Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jilin University First Hospital

Changchun, Jilin, China

Countries

China

Other Identifiers

STARS-CC02

Identifier Type: -

Identifier Source: org_study_id