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Hybrid RAS study

Randomized controlled trial to evaluate the efficacy of hybrid robot-assisted surgery using a laparoscopic device in robotic-assisted colorectal cancer surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240215
Enrollment
120
Registered
2024-12-13
Start date
2025-01-28
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

colon cancer

Interventions

Hybrid robotic surgery

Sponsors

Watanabe Jun
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients whose age at registration is 18 years or older. 2. Patients who are histologically proven to be colon cancer. 3. Preoperative diagnosis of curative primary resection. 4. Main tumor site is cecum (C), ascending colon (A) , sigmoid colon (S) or rectosigmoid colon (RS) and robotic-surgery 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 with General State Performance Status(ECOG) 0 to 1. 7. Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor in charge of examination with in 28 days prior to the registration. 8. Patients who have the judgment to fully understand the research content. 9. Patients with written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients planning combined resection of other organs due to infiltration of other organs 2. Patients with chemotherapy (systemic anti-cancer drug treatment) and a history of radiation therapy, including treatment for other cancer species. 3. Patients who have a history of open surgery. 4. Patients who have a history of laparoscopic stomach resection or colectomy. 5. Patients planning simultaneous resection of other organs due to double cancer. 6. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer. 7. Patients with intraperitoneal infection. 8. Patients with serious complications. 9. Other patients judged inappropriate by the examining physician.

Design outcomes

Primary

MeasureTime frame
Operating time

Secondary

MeasureTime frame
Anastomosis time (min) loss of blood volume(mL) Complications during surgery The date of postoperative first flatus, postoperative first bowel movement, and postoperative diet resumption White blood cell count, CRP (3 days after surgery) Number of dissected lymph nodes Proximal margin(PM) and distal margin(DM) Assessment of surgeon stress(SURG TLX score) Assessment of surgeon satisfaction(VAS score) Rehospitalization, Reoperation Postoperative complications Disease-free interval/rate(Year 3, Year 5), overall survival period/rate(Year 3, Year 5) Cost of surgery

Contacts

Public ContactYusuke Suwa

Kansai Medical University Hospital

suwa.yus@kmu.ac.jp+81-72-804-0101

Outcome results

None listed

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