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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03696472
Other study ID # RoboticALH
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2018
Est. completion date December 2020

Study information

Verified date October 2018
Source Southwest Hospital, China
Contact Li Chuan, M.D
Phone +862368754167
Email lee_tran@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection.

Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated


Description:

Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2
Est. completion date December 2020
Est. primary completion date November 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,?4?,b N0-2 Tolerance of chemotherapy ECOG 0-2

Exclusion Criteria:

With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
robotic assisted surgery
robotic assisted surgery was benefit to operation
laparoscopic
conventional laparoscopic surgery

Locations

Country Name City State
China Southwest Hospital Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5-years overall survival rate 5 years
Secondary Short-term morbidity rate 30 days
Secondary Anastomosis leakage rate 6 months
Secondary Operation Time 1 day
Secondary Blood loss during operation 1 day
Secondary Complication incident rate of surgery 1 day
Secondary C-reaction protein level 7 days
Secondary Recovery time after surgery 60 days
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