Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation

Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation - Clinical study of the safety of the da Vinci operation system for rectal cancer and its effectiveness on functional preservation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015436

Enrollment

Registered

2014-11-01

Start date

2014-11-01

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

The rectal cancer operation by the robot assisted surgery using the da Vinci operation system

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients will undergo low anterior resection for rectal cancer. (2) Patients expected to be curatively A. (3) performance Status (ECOG) is either 0 or 1. (4) BMI (body mass index) is under 30. (5) Patients who fulfill all the conditions listed below A) WBC level is greater or equal to 3,000/mm^3. B) PLT level is greater or equal to 100,000/mm^3. C) AST and ALT level are less than or equal to 100 IU/L. D) T-Bil level are less than 2.0 g/dl. E) Serum creatinine level are less than 1.5mg/dl. (6) All details have been explained thoroughly to patients, and they have a full understanding of the study. Patients have agreed to participate in the study of their own will and have signed the letter of consent.

Exclusion criteria

Exclusion criteria: Patients (1) who will undergo neo-adjuvant chemo-radiotherapy, or lateral pelvic lymph node dissection. (2) with distant metastasis or dissemination (3) with bulky tumor, that is over 5cm in diameter (4) who who have undergone previous abdominal surgery, and developed severe abdominal adhesion. (5) active multiple cancer (6) who are or may be pregnant. Also, patients are or lactating. (7) with psychosis (8) prolonged steroid use (9) who had cardiac infarction, or angina within 6 months. (10) with uncontrolled blood pressure (11) with diabetes mellitus and are using insulin, or with uncontrolled diabetes mellitus (12) with respiratory disease who need a continuous oxygen supply (13) patient who have been determined as inappropriate by the person in charge of the research.

Design outcomes

Primary

Measure	Time frame
Urinary dysfunction	—

Secondary

Measure	Time frame
(1) Rate of anastomotic leakage (2) Erectile dysfunction (3) Defecatory dysfunction (4) Stress assessment of surgeon (5) Operation time (6) Completion rate of robot assisted surgery (7) Overall survival (8) Disease free survival (9) Other side effects (exclude (1))	—

Countries

Japan

Contacts

Public ContactTakeshi Ohki

Tokyo Women's Medical University Department of Surgery, Institute of Gastroenterology

ohki.takeshi@twmu.ac.jp03-3353-8111

Outcome results

None listed

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