Evaluation for the safety of robotic-assisted colectomy

Evaluation for the safety of Robotic-assisted colectomy for resectable colon cancer : a multi-institutional, prospective, historical controlled, feasibility study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1032190036

Enrollment

120

Registered

2019-06-07

Start date

2019-07-12

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

Robot-ic assisted right hemicolectomy with lymph node dissection D2 or more.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically diagnosed with colon cancer. 2)Diagnosed operable by image diagnosis method. 3)Tumor location was cecum, ascending colon or transverse colon. 4)cStage I -IIIC(T1-4b,N0-2b,M0:TNM classification) involving D2 or morelymph node dissection. 5)Diagnosed as not applicable for endoscopic resection. 6)Maximum tumor diameter is 8 cm or less. 7)No multiple lesions requiring two or more anastomoses. 8)Performance status(ECOG)is 0~2. 9)Obtained written informed consent for robotic colectomy at one's own expense. 10)Obtained written informed consent for participation in this study.

Exclusion criteria

Exclusion criteria: 1)Had a history of chemotherapy and radiation therapy, including treatment for other cancer type. 2)Had a history of stomach or intestinal resection surgery(including stomach),excluding appendectomyabdominal surgery. 3)WBC100 IU/L,ALT>100 IU/L,serum Cr>1.5 mg/dL (Latest test value within 14 days before registration) 4)Other, Patients judged as inappropriate by investigator.

Design outcomes

Primary

Measure	Time frame
Proportion of the conversion to open surgery(Indicated conversion,Technical conversion,Complicative conversion)	—

Secondary

Measure	Time frame
1)Proportion of the conversion to open surgery (for patents who had completed protocol treatment) 2)Postoperative complications within 30 days after surgery (all complications of Clavien-Dindo classification grade II or more, leak, surgical site infection) 3)Proportion of Readmission within 30 days after surgery 4)Surgery-related mortality 5)Proportion of intraoperative adverse effects (vascular injury/ organ injury/ reconstruction/ other) 6)Postoperative recovery (Length of post-operative hospital stay, first flatus and oral diet) 7)Surgical outcomes (estimate blood loss, operative time, console time, lymph nodes harvested) 8)Learning curve 9)Proportion of abdominal incisional hernia (5 years) 10)Proportion of recurrent peritoneal dissemination (5 years) 11)Overall survival (5 years) 12)Disease free survival (5 years)	—

Measure

Time frame

1)Proportion of the conversion to open surgery (for patents who had completed protocol treatment) 2)Postoperative complications within 30 days after surgery (all complications of Clavien-Dindo classification grade II or more, leak, surgical site infection) 3)Proportion of Readmission within 30 days after surgery 4)Surgery-related mortality 5)Proportion of intraoperative adverse effects (vascular injury/ organ injury/ reconstruction/ other) 6)Postoperative recovery (Length of post-operative hospital stay, first flatus and oral diet) 7)Surgical outcomes (estimate blood loss, operative time, console time, lymph nodes harvested) 8)Learning curve 9)Proportion of abdominal incisional hernia (5 years) 10)Proportion of recurrent peritoneal dissemination (5 years) 11)Overall survival (5 years) 12)Disease free survival (5 years)

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Contacts

Public ContactSHINICHI YAMAUCHI

INSTITUTE OF SCIENCE TOKYO HOSPITAL

s-yamauchi.srg2@tmd.ac.jp+81-3-5803-5254

Outcome results

None listed

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