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NCT03931980 Clinical Trial

Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

Rectal Cancer Clinical Trial

Official title:
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03931980
Other study ID # BD012019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date June 11, 2021

Study information
Verified date March 2022
Source Binh Dan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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".

Description:

Rectal cancer is a common surgical disease

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 11, 2021
Est. primary completion date March 4, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer

Locations
Country Name City State
Vietnam Binh Dan hospital Ho Chi Minh City

Sponsors (1)
Lead Sponsor Collaborator
Binh Dan Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary Conversion to open surgery the rate of conversion to open surgery 1 day
Secondary Time of surgery Time of surgery on the robot compare to laparoscopic surgery 1 day
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