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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04843189
Acronym
STARS-CC02
Enrollment
648
Registered
2021-04-13
Start date
2021-05-01
Completion date
2023-05-01
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Da Vinci Robot, Surgery

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.

Interventions

Da Vinci Robotic Surgery

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of lymph nodes harvestedDuring the operationNumber of lymph nodes harvested

Secondary

MeasureTime frameDescription
Length of surgical incisionDuring the operationLength of surgical incision
Intraoperative blood lossDuring the operationIntraoperative blood loss
Intraoperative concversion rateDuring the operationIntraoperative concversion rate
Operation timeDuring the operationOperation time
3-year disease-free survival3 years after surgery3-year disease-free survival
5-year overall survival5 years after surgery5-year overall survival
Postoperative recoveryDuring the postoperative hospital stayfirst exhaust, defecation time, restoring liquid diet, hospitalization days, etc.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026