Status:
COMPLETED
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
National Cancer Center, Korea
Conditions:
Rectal Cancer
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphi...
Detailed Description
This prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. Because of ethical issues, it is difficult to conduct as a randomized ...
Eligibility Criteria
Inclusion
- Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid rectoscopy)
- Patient who understands and accepts to sign the informed consent form
- Confirmed preoperative colonoscopic biopsy (adenocarcinoma)
- Proper bone marrow function
- Proper renal function
- Proper liver function
- No severe comorbidity
Exclusion
- Metastatic lesion detected in preoperative assessment
- Previous history of cancer disease. (except patients with skin cancer)
- Severe heart disease, congestive heart disease.
- Severe lung disease, respiratory failure.
- Mental illness.
- Invasion to prostate, bladder and combined resection needed (partial or radical.• Legally prohibited for clinical trial.
- Pregnancy or breast feeding.
- Previous disease or disability expected to influence the assessment of postoperative quality of life.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT01461525
Start Date
October 1 2011
End Date
June 1 2020
Last Update
December 5 2024
Active Locations (6)
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1
Hallym University College of Medicine
Anyang-si, Gyeonggi-do, South Korea, 431-070
2
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769
3
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
4
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 110-744