Evaluation for the safety of robotic-assisted colectomy

Phase 2

• Conditions: Colon cancer

• Registration Number: JPRN-jRCT1032190036
• Lead Sponsor: KINUGASA YUSUKE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

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)WBC<3000/mm3,PLT<100,000/mm3,Hb<7.0 g/dL,AST>100 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of the conversion to open surgery(Indicated conversion,Technical conversion,Complicative conversion)

Secondary Outcome Measures

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