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

• Sponsor: The First Hospital of Jilin University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04843189
• Collaborator: (none)
• Enrollment: 648
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 27

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Da Vinci Robot; Colon Cancer; Surgery	Procedure: Da Vinci Robotic Surgery

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 648 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
• Anticipated Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Da Vinci Robotic Surgery Group Da Vinci Robotic Surgery Group	Procedure: Da Vinci Robotic Surgery; Da Vinci Robotic Surgery
Laparoscopy-assisted surgery group Laparoscopy-assisted surgery group	Procedure: Da Vinci Robotic Surgery; Da Vinci Robotic Surgery

Outcome Measures

Primary Outcome Measures

1. Number of lymph nodes harvested [During the operation]

   Number of lymph nodes harvested

Secondary Outcome Measures

1. Operation time [During the operation]

   Operation time

2. Length of surgical incision [During the operation]

   Length of surgical incision

3. Intraoperative blood loss [During the operation]

   Intraoperative blood loss

4. Intraoperative concversion rate [During the operation]

   Intraoperative concversion rate

5. Postoperative recovery [During the postoperative hospital stay]

   first exhaust, defecation time, restoring liquid diet, hospitalization days, etc.

6. 3-year disease-free survival [3 years after surgery]

   3-year disease-free survival

7. 5-year overall survival [5 years after surgery]

   5-year overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jilin University First Hospital	Changchun	Jilin	China	130021

Sponsors and Collaborators

• The First Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Quan Wang, Professor, The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT04843189
• Other Study ID Numbers: STARS-CC02
• First Posted: Apr 13, 2021
• Last Update Posted: Apr 13, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Apr 13, 2021