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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
| Seoul National University Boramae Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sphincter preservation surgery | Experimental | Temporary ileostomy with anal sphincter preservation |
|
| Abdominoperineal Resection | Experimental | Permanent colostomy with total anal sphincter sacrifice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominoperineal resection | Procedure | After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life outcome | Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oncologic outcomes | Oncologic outcomes (recurrence, survival) | 5 years |
| Bladder function | Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Bum Kang, Ph. D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University College of Medicine | Anyang-si | Gyeonggi-do | 431-070 | South Korea | ||
| National Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34327411 | Derived | Kang SB, Cho JR, Jeong SY, Oh JH, Ahn S, Choi S, Kim DW, Lee BH, Youk EG, Park SC, Heo SC, Lee DS, Ryoo SB, Park JW, Park HC, Lee SM, Kang SI, Kim MH, Oh HK, Shin R, Kim MJ, Lee KH, Kim YH, Kim JS, Lee KW, Lee HS, Kim HJ, Park YS, Sohn DK, Park KJ; Seoul Colorectal Research Group (SECOG). Quality of life after sphincter preservation surgery or abdominoperineal resection for low rectal cancer (ASPIRE): A long-term prospective, multicentre, cohort study. Lancet Reg Health West Pac. 2020 Dec 28;6:100087. doi: 10.1016/j.lanwpc.2020.100087. eCollection 2021 Jan. |
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| Hallym University Medical Center |
| OTHER |
| Daehang Hospital | OTHER |
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|
| Sphincter preservation surgery | Procedure | 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 |
|
|
| 3 years |
| Sexual function | Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months). | 3 years |
| Anal function | Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months). | 3 years |
| Goyang-si |
| Gyeonggi-do |
| 410-769 |
| South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | Jongno-gu | 110-744 | South Korea |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | 156-707 | South Korea |
| Daehang Hospital | Seoul | 481-10 | South Korea |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000078542 | Proctectomy |
| ID | Term |
|---|---|
| D000099090 | Surgical Procedures, Colorectal |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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