Back to resultsRobotic-assisted Left Hemicolectomy for Left Colon Cancer (RALH)
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
robotic assisted surgery
laparoscopic
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer
Eligibility Criteria
Inclusion Criteria:
Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2
Exclusion Criteria:
With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy
Sites / Locations
- Southwest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
robotic-assisted left colonic resection
laparoscopic left colonic resection
Arm Description
Standard left colonic resection assisted by Davinci Robotic
Standard laparoscopic left colonic resection
Outcomes
Primary Outcome Measures
5-years overall survival rate
Secondary Outcome Measures
Short-term morbidity rate
Anastomosis leakage rate
Operation Time
Blood loss during operation
Complication incident rate of surgery
C-reaction protein level
Recovery time after surgery
Full Information
NCT ID
NCT03696472
First Posted
April 24, 2018
Last Updated
October 5, 2018
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03696472
Brief Title
Robotic-assisted Left Hemicolectomy for Left Colon Cancer
Acronym
RALH
Official Title
Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robotic-assisted left colonic resection
Arm Type
Experimental
Arm Description
Standard left colonic resection assisted by Davinci Robotic
Arm Title
laparoscopic left colonic resection
Arm Type
Active Comparator
Arm Description
Standard laparoscopic left colonic resection
Intervention Type
Procedure
Intervention Name(s)
robotic assisted surgery
Intervention Description
robotic assisted surgery was benefit to operation
Intervention Type
Procedure
Intervention Name(s)
laparoscopic
Intervention Description
conventional laparoscopic surgery
Primary Outcome Measure Information:
Title
5-years overall survival rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Short-term morbidity rate
Time Frame
30 days
Title
Anastomosis leakage rate
Time Frame
6 months
Title
Operation Time
Time Frame
1 day
Title
Blood loss during operation
Time Frame
1 day
Title
Complication incident rate of surgery
Time Frame
1 day
Title
C-reaction protein level
Time Frame
7 days
Title
Recovery time after surgery
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2
Exclusion Criteria:
With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Chuan, M.D
Phone
+862368754167
Email
lee_tran@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tang Bo, M.D
Phone
+86-18323479228
Email
tangtbo@sina.cn
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Peiwu, M.D/Ph.D
Phone
+862368754167
Email
yupeiwu1961@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Robotic-assisted Left Hemicolectomy for Left Colon Cancer
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