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

• Conditions: Da Vinci Robot; Colon Cancer; Surgery
• Interventions: Procedure: Da Vinci Robotic Surgery

• Registration Number: NCT04843189
• Lead Sponsor: The First Hospital of Jilin University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Study First Posted: 2021-04-13
• Last Update Posted: 2021-04-13
• Study Start: 2021-05-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 648

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Da Vinci Robotic Surgery Group	Da Vinci Robotic Surgery	Da Vinci Robotic Surgery Group
Laparoscopy-assisted surgery group	Da Vinci Robotic Surgery	Laparoscopy-assisted surgery group

Primary Outcome Measures

Name	Time	Method
Number of lymph nodes harvested	During the operation	Number of lymph nodes harvested

Secondary Outcome Measures

Name	Time	Method
3-year disease-free survival	3 years after surgery	3-year disease-free survival
Operation time	During the operation	Operation time
Length of surgical incision	During the operation	Length of surgical incision
Intraoperative blood loss	During the operation	Intraoperative blood loss
Intraoperative concversion rate	During the operation	Intraoperative concversion rate
Postoperative recovery	During the postoperative hospital stay	first exhaust, defecation time, restoring liquid diet, hospitalization days, etc.
5-year overall survival	5 years after surgery	5-year overall survival

Trial Locations

Locations (1)

Jilin University First Hospital; 🇨🇳 Changchun, Jilin, China