Study on the Safety and Efficacy of da Vinci-Assisted Rectal Surgery

Short- and Long-Term Safety and Efficacy of Robot-Assisted Rectal Surgery Using the da Vinci System Based on the Japanese Medical Data Vision Analysis - A Study on da Vinci-Assisted Rectal Surgery (SVARS)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055855

Enrollment

28500

Registered

2024-12-01

Start date

2025-07-01

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

Rectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cases registered in the MDV database where open, laparoscopic, or robot-assisted rectal resection/amputation was performed between April 1, 2018, and June 30, 2024. Cases with a preoperative diagnosis of Stage I-III. Cases where the admission diagnosis is registered as "C20 Malignant Neoplasm of the Rectum." Cases that include preoperative radiation therapy and/or chemotherapy. No age restrictions.

Exclusion criteria

Exclusion criteria: Cases with incomplete data. Cases with an unknown preoperative stage. Cases with a preoperative diagnosis of Stage IV. Cases involving simultaneous surgery on other organs.

Design outcomes

Primary

Measure	Time frame
5-year overall survival rate, 5-year recurrence-free survival rate	—

Secondary

Measure	Time frame
1)The incidence rate and breakdown of complications registered with ICD-10 codes within 30 days after surgery, including: Anastomotic leakage, peritonitis, intra-abdominal bleeding, bowel obstruction, surgical site infection, urinary retention, pneumonia, pulmonary thromboembolism, surgical wound infection, urinary tract infection, myocardial infarction, deep vein thrombosis, postoperative septic shock, ileus, and others. 2)Intraoperative blood transfusion rate 3)Postoperative length of hospital stay 4)Incidence rate of unplanned readmissions within 30 days after surgery 5)Incidence rate of reoperation within 30 days after surgery 6)Incidence rate of death within 30 and 90 days after surgery	—

Measure

Time frame

1)The incidence rate and breakdown of complications registered with ICD-10 codes within 30 days after surgery, including: Anastomotic leakage, peritonitis, intra-abdominal bleeding, bowel obstruction, surgical site infection, urinary retention, pneumonia, pulmonary thromboembolism, surgical wound infection, urinary tract infection, myocardial infarction, deep vein thrombosis, postoperative septic shock, ileus, and others. 2)Intraoperative blood transfusion rate 3)Postoperative length of hospital stay 4)Incidence rate of unplanned readmissions within 30 days after surgery 5)Incidence rate of reoperation within 30 days after surgery 6)Incidence rate of death within 30 and 90 days after surgery

—

Countries

Japan

Contacts

Public ContactMarie Hanaoka

Institute of Science Tokyo Department of Gastrointestinal Surgery

fujimarimarie@yahoo.co.jp09050750189

Outcome results