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Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
Conditions
Rectal Cancer
Conditions: Keywords
Low Rectal Cancer, Sphincter preservation, Abdominoperineal resection, Quality of life, Sexual function, Urinary function, Oncologic outcome
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Abdominoperineal resection
Type: Procedure
Name: Sphincter preservation surgery
Type: Procedure
Overall Status
Recruiting
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 sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.
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 trial. On the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. On the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing APR and 220 patients undergoing SPS will be recruited. The study will be continued until the target sample size will be achieved.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:
- 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 Criteria:
- 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.
- 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 Criteria:
- 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.
Locations
Hallym University College of Medicine
Anyang, Gyeong-gi, Korea, Republic of
National Cancer Center
Status: Recruiting
Contact: Bong Hwa Lee, M.D, Ph.D - 82-31-380-3041 - bshlee@hallym.or.kr
Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
Status: Recruiting
Contact: Jae-Hwan Oh, Ph.D. - jayoh@ncc.re.kr
SeongNam, GyeongGi, Korea, Republic of
Seoul National University Hospital
Status: Recruiting
Contact: Sung-Bum Kang, Ph. D. - +82-31-787-7093 - kangsb@snubh.org
Seoul, Jongno-gu, Korea, Republic of
Daehang Hospital
Status: Recruiting
Contact: Kyu Joo Park, Ph.D. - kjparkmd@plaza.snu.ac.kr
Seoul, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Status: Recruiting
Contact: Eui Gon Youk, M.D, Ph.D
Seoul, Korea, Republic of
Status: Recruiting
Contact: Seung Chul Heo, M.D,Ph.D - 82-2-870-2273 - heosc3@brm.co.kr
Start Date
October 2011
Completion Date
June 2016
Sponsors
Seoul National University Hospital
Source
Seoul National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page