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Robotic Lateral versus Medial Approach for Left-Sided Colorectal Cancer: A Multicenter Randomized Controlled Trial

Robotic Lateral versus Medial Approach for Left-Sided Colorectal Cancer: A Multicenter Randomized Controlled Trial - RoLAT Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058932
Enrollment
80
Registered
2025-08-29
Start date
2025-09-01
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

Patients undergoing robotic-assisted left-sided colorectal cancer surgery using the lateral approach, in which mesocolic dissection is initiated by incising the lateral peritoneum. Patients undergoing

Sponsors

Department of Gastrointestinal Surgery, Kariya Toyota General Hospital
Lead Sponsor
Nagoya City University West Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients scheduled to undergo robotic-assisted colorectal resection with D3 lymphadenectomy (including high ligation of the inferior mesenteric artery) for sigmoid colon cancer or rectal cancer (or suspected cases). 2) Patients with a clinical tumor depth of cT1 to cT3. 3) Patients with an ECOG Performance Status of 0 to 2. 4) Patients who are willing to participate in this study, have provided written informed consent, and are 20 years of age or older at the time of consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding patients, or those with a possibility of pregnancy 2. Patients in whom lymph node dissection is not performed 3. Patients diagnosed with multiple colorectal cancers 4. Patients with a history of colorectal resection 5. Patients diagnosed preoperatively with bowel obstruction, perforation, or penetration 6. Patients diagnosed preoperatively with PDM 7. Patients scheduled for robot-assisted surgery but converted preoperatively to open or laparoscopic surgery 8. Patients whose consent cannot be obtained due to inability to confirm their own will (e.g., dementia, impaired consciousness) 9. Patients with poorly controlled diabetes mellitus 10. Patients with unstable angina (angina pectoris that developed within the past 3 weeks or has worsened recently) or a history of myocardial infarction within the past 6 months 11. Patients with poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy 12. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs 13. Patients with a history of chemotherapy or radiotherapy 14. Any other patients deemed unsuitable for participation in this study by the principal investigator or co-investigators

Design outcomes

Primary

MeasureTime frame
Time from the initiation of medial or lateral peritoneal incision to the completion of mesocolic mobilization, including central vascular ligation.

Secondary

MeasureTime frame
1.Surgical outcomes Operative time (minutes) Dissection time (minutes) Blood loss (mL) Intraoperative complications (yes/no) Conversion rate to laparoscopic or open surgery Quality of dissection (video assessment) 2. Postoperative course Postoperative hospital stay (days) Postoperative complications within 30 days (Clavien Dindo classification) Readmission within 30 days (yes/no) Reoperation within 30 days (yes/no) 3.Long term outcomes Recurrence (yes/no) Site of recurrence Time to recurrence (months from surgery) Survival status (overall survival, recurrence free survival) 4.Learning curve evaluation Changes in operative time and dissection time according to case sequence for each surgeon Analysis using CUSUM method 5.Surgeon stress assessment Evaluated immediately after surgery using the SURG TLX questionnaire

Countries

Japan

Contacts

Public ContactYoshiaki Fujii

Kariya Toyota General Hospital Department of Gastrointestinal Surgery

inakin1208inakin@gmail.com0566-25-2950

Outcome results

None listed

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