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Robotic-assisted Left Hemicolectomy for Left Colon Cancer (RALH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03696472
Recruitment Status : Unknown
Verified October 2018 by Li Chuan, Southwest Hospital, China.
Recruitment status was:  Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Li Chuan, Southwest Hospital, China

Study Description
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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


Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: robotic assisted surgery Procedure: laparoscopic Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: robotic-assisted left colonic resection
Standard left colonic resection assisted by Davinci Robotic
 Procedure: robotic assisted surgery
robotic assisted surgery was benefit to operation
Active Comparator: laparoscopic left colonic resection
Standard laparoscopic left colonic resection
 Procedure: laparoscopic
conventional laparoscopic surgery


Outcome Measures
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Primary Outcome Measures :
  1. 5-years overall survival rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Short-term morbidity rate [ Time Frame: 30 days ]
  2. Anastomosis leakage rate [ Time Frame: 6 months ]
  3. Operation Time [ Time Frame: 1 day ]
  4. Blood loss during operation [ Time Frame: 1 day ]
  5. Complication incident rate of surgery [ Time Frame: 1 day ]
  6. C-reaction protein level [ Time Frame: 7 days ]
  7. Recovery time after surgery [ Time Frame: 60 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696472


Contacts
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Contact: Li Chuan, M.D +862368754167 lee_tran@126.com
Contact: Tang Bo, M.D +86-18323479228 tangtbo@sina.cn

Locations
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China
Southwest Hospital
Chongqing, China, 400038
Contact: Yu Peiwu, M.D/Ph.D    +862368754167    yupeiwu1961@aliyun.com   
Sponsors and Collaborators
Southwest Hospital, China
More Information
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Responsible Party: Li Chuan, Secretary of General Surgery, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03696472    
Other Study ID Numbers: RoboticALH
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases