Status:
UNKNOWN
A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer
Lead Sponsor:
Kyungpook National University Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study sets up the final study end point and three detailed goals as the following. The main objective of study: This trial is done to assess the safety and benefit of robotic resection compared ...
Detailed Description
Recently, the efficacy and oncological safety of laparoscopy has been demonstrated for treating colon cancer, and similar long-term results at 5-year confirmed by the several multicenter study trial. ...
Eligibility Criteria
Inclusion
- Eligibility rule of enrollment
- Rectal adenocarcinoma that were 10 cm or less from the anal verge
- at least 18 years old \& at most 80 years old
- Clinically diagnosed cT3N0-2 disease
- Clinical diagnosis of carcinoma involving a single rectal segment
- Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography
Exclusion
- The presence of metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, lateral pelvic wall lymph node and inguinal lymph node
- A past history of the cancer occurring in other body areas than the rectal cancer (except for a past history of the radical resection due to skin cancer)
- Severe cardiac diseases or failure
- Severe pulmonary diseases or dysfunction
- The presence of psychiatric diseases
- The concurrent presence of other severe medical diseases
- An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT01423214
Start Date
June 1 2013
End Date
December 1 2018
Last Update
March 11 2015
Active Locations (3)
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1
Gyu seog Choi
Daegu, South Korea, 702-210
2
Nam Kyu Kim
Seoul, South Korea, 120-752
3
Seon-Hahn Kim
Seoul, South Korea, 136-705