Trial record 8 of 24 for:
colostomy | Open Studies
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Collaborators:
Seoul National University Bundang Hospital
National Cancer Center, Korea
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang hospital
Information provided by (Responsible Party):
Sung-Bum Kang, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01461525
First received: October 20, 2011
Last updated: April 13, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rectal Cancer |
Procedure: Abdominoperineal resection Procedure: Sphincter preservation surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
Secondary Outcome Measures:
- Oncologic outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]Oncologic outcomes (recurrence, survival)
- Bladder function [ Time Frame: 3 years ] [ Designated as safety issue: No ]Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).
- Sexual function [ Time Frame: 3 years ] [ Designated as safety issue: No ]Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
- Anal function [ Time Frame: 3 years ] [ Designated as safety issue: No ]Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months).
| Estimated Enrollment: | 294 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sphincter preservation surgery
Temporary ileostomy with anal sphincter preservation
|
Procedure: Sphincter preservation surgery
After high ligation of IMA, TME with autonomic nerve preservation, sphincter preservation and proctectomy with distal margin of more than 0.5cm in length and temporary ileostomy
Other Name: SPS
|
|
Experimental: Abdominoperineal Resection
Permanent colostomy with total anal sphincter sacrifice
|
Procedure: Abdominoperineal resection
After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.
Other Names:
|
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. Sample sized was calculated as 294 patients in the estimated enrollment of 1 to 3(APR: ISR)
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam)
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461525
Contacts
| Contact: Sung-Bum Kang, Ph. D. | +82-31-787-7093 | kangsb@snubh.org |
| Contact: Duck-Woo Kim, Ph. D. | +82-31-787-7101 | kdw@snubh.org |
Locations
| Korea, Republic of | |
| Hallym University College of Medicine | Recruiting |
| Anyang, Gyeong-gi, Korea, Republic of, 431-070 | |
| Contact: Bong Hwa Lee, M.D, Ph.D 82-31-380-3041 bshlee@hallym.or.kr | |
| Contact: Hyoung-Chul Park, M.D, Ph.D 82-31-380-3041 greatpa1@hallym.or.kr | |
| Principal Investigator: Bong Hwa Lee, M.D, Ph.D | |
| Sub-Investigator: Hyeong-Chul Heo, M.D, Ph.D | |
| National Cancer Center | Recruiting |
| Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
| Contact: Jae-Hwan Oh, Ph.D. jayoh@ncc.re.kr | |
| Contact: Ji-Won Park, Ph.D. sowisdom@ncc.re.kr | |
| Principal Investigator: Jae-Hwan Oh, Ph.D. | |
| Sub-Investigator: Sung-Chan Park, Ph.D. | |
| Sub-Investigator: Ji-Won Park, Ph.D. | |
| Seoul National University Bundang Hospital | Recruiting |
| SeongNam, GyeongGi, Korea, Republic of, 463-707 | |
| Contact: Sung-Bum Kang, Ph. D. +82-31-787-7093 kangsb@snubh.org | |
| Contact: Duck-Woo Kim, Ph. D. +82-31-787-7101 kdw@snubh.org | |
| Principal Investigator: Sung-Bum Kang, Ph. D. | |
| Sub-Investigator: Duck-Woo Kim, Ph. D | |
| Sub-Investigator: Je-Ho Jang, M. D. | |
| Sub-Investigator: Sung-Min Lee, M.D. | |
| Sub-Investigator: Jae-Sung Kim, Ph.D. | |
| Sub-Investigator: JeeHyun Kim | |
| Sub-Investigator: Keun Wook Lee, Ph.D. | |
| Sub-Investigator: Hye-Seung Lee, Ph.D. | |
| Sub-Investigator: Young-Hoon Kim, Ph.D. | |
| Sub-Investigator: Keyong-Ho Lee, Ph.D. | |
| Sub-Investigator: Soyeon Ahn, Ph.D | |
| Sub-Investigator: Soo Young Lee, M.D. | |
| Seoul National University Hospital | Recruiting |
| Seoul, Jongno-gu, Korea, Republic of, 110-744 | |
| Contact: Kyu Joo Park, Ph.D. kjparkmd@plaza.snu.ac.kr | |
| Contact: Seung-Yong Jeong syjeong@snu.ac.kr | |
| Principal Investigator: Kyu Joo Park, Ph.D. | |
| Sub-Investigator: Seung-Yong Jeong, Ph.D. | |
| Sub-Investigator: Heon-Kyun Ha, M.D | |
| Sub-Investigator: Min Jeong Kim, M.D | |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Recruiting |
| Seoul, Korea, Republic of, 156-707 | |
| Contact: Seung Chul Heo, M.D,Ph.D 82-2-870-2273 heosc3@brm.co.kr | |
| Contact: Rumi Shin, M.D 82-2-2072-0612 roomie79@gmail.com | |
| Principal Investigator: Seung Chul Heo, M.D,Ph.D | |
| Sub-Investigator: Rumi Shin, M.D | |
| Daehang Hospital | Recruiting |
| Seoul, Korea, Republic of, 481-10 | |
| Contact: Eui Gon Youk, M.D, Ph.D | |
| Principal Investigator: Eui Gon Youk, M.D, Ph.D | |
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
National Cancer Center, Korea
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang hospital
Investigators
| Principal Investigator: | Sung-Bum Kang, Ph. D. | Seoul National University Bundang Hospital |
More Information
No publications provided
| Responsible Party: | Sung-Bum Kang, Principal Investigator, Seoul National University Bundang Hospital |
| ClinicalTrials.gov Identifier: | NCT01461525 History of Changes |
| Other Study ID Numbers: | APR-SPS trial |
| Study First Received: | October 20, 2011 |
| Last Updated: | April 13, 2013 |
| Health Authority: | Korea: Food and Drug Administration Korea: Institutional Review Board Korea: Ministry for Health, Welfare and Family Affairs |
Keywords provided by Seoul National University Hospital:
|
Low Rectal Cancer Sphincter preservation Abdominoperineal resection Quality of life |
Sexual function Urinary function Oncologic outcome |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013