- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03931980
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Colorectal cancer is a common malignancy in Viet Nam. Laparoscopic surgery becomes a standard treatment in many centers. Today, robotic surgery is a new option for treating colorectal cancer with some advantages such as magnified 3D view, precise movements.
Answer on safety and feasibility of robotic surgery for colorectal cancer are not available in Viet Nam. Therefore, the investigators conducted a study " Robotic versus Laparoscopic Approach for Rectal Cancer Surgery".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ho Chi Minh City, Vietnam, 70000
- Binh Dan Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- able to provide written informed consent
- Diagnosis of rectal cancer amenable to curative surgery by anterior resection, low anterior resection, ultra-low anterior resection, abdominal perineal resection, staged T1-T4a, N0-2, M0
Exclusion Criteria:
- Advanced cancer not amenable to curative surgery
- patient did not agree to participate in research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Robotic surgery
Patients undergoing robotic surgery for removal of rectal cancer.
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we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
Other Names:
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EXPERIMENTAL: Laparoscopic surgery
Patients undergoing laparoscopic for removal of rectal cancer
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we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion to open surgery
Time Frame: 1 day
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the rate of conversion to open surgery
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of surgery
Time Frame: 1 day
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Time of surgery on the robot compare to laparoscopic surgery
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hung V Tran, PhD, Binh Dan Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BD012019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Cancer
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Ohio State University Comprehensive Cancer CenterNovartis Pharmaceuticals; National Comprehensive Cancer NetworkCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Recurrent Rectal CancerUnited States
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M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
-
OHSU Knight Cancer InstituteNatera, Inc.RecruitingEstablishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Rectal AdenocarcinomaUnited States
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OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
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Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
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Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
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National Cancer Institute (NCI)Active, not recruitingMetastatic Rectal Adenocarcinoma | Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Stage IV Rectal Cancer AJCC v7 | Stage IVA Rectal Cancer AJCC v7 | Stage IVB Rectal Cancer AJCC v7 | Locally...United States
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City of Hope Medical CenterWithdrawnRecurrent Rectal Cancer | Stage I Rectal Cancer | Stage II Rectal Cancer | Stage III Rectal Cancer
Clinical Trials on Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
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University of California, IrvineUniversity of LeedsCompleted
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Taiyuan LiCompletedRectal Neoplasms | Robotic Surgery | Natural Orifice Specimen Extraction Surgery
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The University of Hong KongUnknownAdenocarcinoma | Rectal CancerHong Kong
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Mansoura UniversityUniversity of Rome Tor VergataCompletedAnastomotic LeakageEgypt, Italy
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Fujian Medical UniversityZhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Peking Union... and other collaboratorsActive, not recruiting
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedColorectal CancerUnited States, Canada
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National Cancer Center, KoreaUnknownRectal CancerKorea, Republic of
-
Sohag UniversityRecruiting
-
Osama Mohammad Ali ElDamshetyMansoura University; Marche Polytechnic university, Ancona, ItalyCompleted