Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial (ASPIRE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01461525|
Recruitment Status : Active, not recruiting
First Posted : October 28, 2011
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Procedure: Abdominoperineal resection Procedure: Sphincter preservation surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||342 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2021|
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.
- Quality of life outcome [ Time Frame: 3 years ]Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
- Oncologic outcomes [ Time Frame: 5 years ]Oncologic outcomes (recurrence, survival)
- Bladder function [ Time Frame: 3 years ]Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).
- Sexual function [ Time Frame: 3 years ]Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
- Anal function [ Time Frame: 3 years ]Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461525
|Korea, Republic of|
|Hallym University College of Medicine|
|Anyang, Gyeong-gi, Korea, Republic of, 431-070|
|National Cancer Center|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Seoul National University Bundang Hospital|
|SeongNam, GyeongGi, Korea, Republic of, 463-707|
|Seoul National University Hospital|
|Seoul, Jongno-gu, Korea, Republic of, 110-744|
|Seoul Metropolitan Government Seoul National University Boramae Medical Center|
|Seoul, Korea, Republic of, 156-707|
|Seoul, Korea, Republic of, 481-10|
|Principal Investigator:||Sung-Bum Kang, Ph. D.||Seoul National University Bundang Hospital|