ROBOCOLO study

Phase 2

• Conditions: Health Condition(s) or Problem(s) Studied Colon cancer

• Registration Number: JPRN-jRCT1032210196
• Lead Sponsor: Ishibe Atsushi

Brief Summary

This study demonstrated the safety and feasibility of robotic surgery for right-sided colon cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-14
• Study Completion: 2023-03-13
• Results First Posted: 2023-07-19
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Patients over 20 years old age
2. Histologically, diagnosed with colon cancer
3. Preoperative diagnosis of curative primary resection
4. Main tumor site is cecum (C), ascending colon (A) or right-sided transverse colon (T) and right-hemicolectomy with D2 or higher lymph node dissection is pre-planned
5. Clinical stage I to IIIC (T1-4b, N0-2b, M0: TNM Classification) has been diagnosed
6. Patients who are diagnosed out of the endoscopic resection
7. Patients with tumor maximum diameter of 8 cm or less
8. Patients who do not recognize multiple lesions that require two or more anastomosis places
9. Patients with ECOG Performance Status (PS) score of 0 to 1
10. Patients who have the judgment to fully understand the research content.
11. Patients with written informed consent to participate in this study.

Exclusion Criteria

1. Patients with chemotherapy (systemic anti-cancer drug treatment) and a history of radiation therapy, including treatment for other cancer species.
2. Patients who have a history of open surgery
3. Patients who have a history of laparoscopic stomach resection or colectomy
4. Patients with the latest check values within 14 days before registration meet the following
Leukocyte <3000 / mm 3,
Platelet <75,000 / mm 3,
Hemoglobin <7 G / DL,
AST> 100 IU / L,
ALT> 100 IU / L,
Serum Cr> 1.5 mg / dl.
5. Other patients who are judged to be unsuitable as a subject by the doctor's judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications within 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
1. Conversion rate<br>2. Readmission rate within 30 days after surgery<br>3. Mortality rate within 30 days after surgery<br>4. Intraoperative adverse events (vascular damage / organ damage / reconstruction / other)<br>5. Postoperative recovery (postoperative hospital stay, time to first flatus, time to first oral intake)<br>6. Surgical results (blood loss, operative time, console time, harvested lymph node number, R0 resection rate)