Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study

Investigation of the effect of robot-assisted surgery for advanced rectal cancer on oncological feasibility: Multicenter, Prospective, Phase II study - VITRUVIANO trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039685

Enrollment

300

Registered

2020-03-04

Start date

2020-03-09

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

advanced rectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically diagnosed with rectal cancer 2) Diagnosed operable by preoperative examination and image diagnosis method 3) Tumor lower margin is less than or equal to 12 cm from the anal verge 4) Tumor location is rectosigmoid (RS), upper rectum (Ra), lower rectum (Rb), proctodeum (P) 5) "cT2-T4a and cN0-N3 and cM0" or "cT1-T4a and cN1-N3 and cM0" (Evaluate before preoperative treatment if patients will undergo preoperative treatment) 6) Diagnosed as not applicable for endoscopic resection 7) Scheduled for robot-assisted rectal resection in routine medical care (Informed consent has been obtained) 8) 20 years or older 9) Written informed consent for participation in this study has been obtained

Exclusion criteria

Exclusion criteria: 1) cT4b 2) Multiple rectal cancer (except Tis) 3) Multiple malignancies 4) Patients whose consent ability is judged to be insufficient (dementia etc.) 5) Other, patients judged inappropriate by investigators

Design outcomes

Primary

Measure	Time frame
Proportion of CRM-negative	—

Secondary

Measure	Time frame
Quality of TME successful resection (CRM-negative, DM-negative and complete TME) Conversion to open surgery Intraoperative adverse effects Surgical outcomes (estimate blood loss, operative time, console time, number of lymph nodes harvested) Postoperative recovery of bowel function (time to first flatus/ stools/ intake of fluid and diet) Postoperative urinary function (residual urine volume/ I-PSS/ OABSS/ ICIQ-SF) Length of postoperative hospital stay Postoperative complications within 30 days after surgery (Clavien-Dindo classification grade III or more) Surgery-related mortality within 30 days after surgery Reoperation within 30 days after surgery 3-year local recurrence-free survival 3-year disease-free survival 3-year overall survival	—

Measure

Time frame

Quality of TME successful resection (CRM-negative, DM-negative and complete TME) Conversion to open surgery Intraoperative adverse effects Surgical outcomes (estimate blood loss, operative time, console time, number of lymph nodes harvested) Postoperative recovery of bowel function (time to first flatus/ stools/ intake of fluid and diet) Postoperative urinary function (residual urine volume/ I-PSS/ OABSS/ ICIQ-SF) Length of postoperative hospital stay Postoperative complications within 30 days after surgery (Clavien-Dindo classification grade III or more) Surgery-related mortality within 30 days after surgery Reoperation within 30 days after surgery 3-year local recurrence-free survival 3-year disease-free survival 3-year overall survival

—

Countries

Japan

Contacts

Public ContactAtsushi Hamabe

The university of osaka hosupital Gastrointestinal surgery

ahamabe@gesurg.med.osaka-u.ac.jp06-6879-5111

Outcome results