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Hugo RAS trial

Prospective single-arm phase II trial on the safety of robot-assisted surgery with the Hugo RAS system for colorectal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052250001
Enrollment
105
Registered
2025-04-03
Start date
2025-07-29
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

colorectal cancer

Interventions

Sponsors

Watanabe Jun
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old age 2. Histologically, diagnosed with colorectal cancer 3. Preoperative diagnosis of curative primary resection 4. D2 or higher lymph node dissection is pre-planned 5. Clinical stage I to IIIC (T1-4b, N0-2b, M0: TNMClassification) has been diagnosed 6. Patients who are diagnosed out of the endoscopic resection 7. Patients with tumor maximum diameter of 8 cmor 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 2 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

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 planning combined resection of other organs due to infiltration of other organs. 3. Patients who have a history of open surgery 4. Patients who have a history of laparoscopic stomach resection or colectomy 5. Patients with the latest check values within 28 days before registration meet the following Leukocyte 100 IU / L, ALT> 100 IU / L, Serum Cr> 1.5 mg / dl. 6. Patients planning simultaneous resection of other organs due to double cancer. 7. Patients with serious complications. 8. Other patients who are judged to be unsuitable as a subject by the doctor's judgment.

Design outcomes

Primary

MeasureTime frame
Postoperative complications within 30 days after surgery

Secondary

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

Contacts

Public ContactNorikazu Yamada

Kansai Medical University Hospital

yamadan@hirakata.kmu.ac.jp+81-72-804-0101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026