Robotic-assisted Left Hemicolectomy for Left Colon Cancer
Sponsor:
Southwest Hospital, China
Collaborators:
Information provided by (Responsible Party):
Li Chuan，Southwest Hospital, China
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | April 24, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | December 2018 | ||
| Estimated Primary Completion Date | November 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
5-years overall survival rate[ Time Frame: 5 years ] |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Robotic-assisted Left Hemicolectomy for Left Colon Cancer |
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| Official Title ICMJE | Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV |
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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 |
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| 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 Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
2 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 2020 | ||
| Estimated Primary Completion Date | November 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: Agreement of the patient to participate in trial Colon cancer (only adenocarcinoma ) The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 (II-III stages) Tolerance of chemotherapy ECOG 0-2 Exclusion Criteria: Patients with distant metastases Tumors T1-2 (I stage) Complications of tumor (perforation and full bowel obstruction) Previous radiotherapy or chemotherapy Synchronous or metachronous tumors Women during Pregnancy or breast feeding period Unable to go through the treatment because of family, society or regional condition | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | China | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Li Chuan，Southwest Hospital, China | ||
| Study Sponsor ICMJE | Southwest Hospital, China | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Southwest Hospital, China | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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