Robotic-assisted Left Hemicolectomy for Left Colon Cancer
RALH
1 other identifier
interventional
2
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 9, 2018
October 1, 2018
1.9 years
April 24, 2018
October 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
5-years overall survival rate
5 years
Secondary Outcomes (7)
Short-term morbidity rate
30 days
Anastomosis leakage rate
6 months
Operation Time
1 day
Blood loss during operation
1 day
Complication incident rate of surgery
1 day
- +2 more secondary outcomes
Study Arms (2)
robotic-assisted left colonic resection
EXPERIMENTALStandard left colonic resection assisted by Davinci Robotic
laparoscopic left colonic resection
ACTIVE COMPARATORStandard laparoscopic left colonic resection
Interventions
robotic assisted surgery was benefit to operation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Hospital
Chongqing, 400038, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Secretary of General Surgery
Study Record Dates
First Submitted
April 24, 2018
First Posted
October 4, 2018
Study Start
December 1, 2018
Primary Completion
November 1, 2020
Study Completion
December 1, 2020
Last Updated
October 9, 2018
Record last verified: 2018-10