Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial (ASPIRE)
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ClinicalTrials.gov Identifier: NCT01461525 |
Recruitment Status :
Active, not recruiting
First Posted : October 28, 2011
Last Update Posted : October 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Rectal Cancer | Procedure: Abdominoperineal resection Procedure: Sphincter preservation surgery | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 342 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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Experimental: Sphincter preservation surgery
Temporary ileostomy with anal sphincter preservation
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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
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Procedure: Abdominoperineal resection
After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.
Other Names:
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- 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).

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 | |
Daehang Hospital | |
Seoul, Korea, Republic of, 481-10 |
Principal Investigator: | Sung-Bum Kang, Ph. D. | Seoul National University Bundang Hospital |
Responsible Party: | Sung-Bum Kang, Director of Colorectal Cancer Center, Principal Investigator, Professor, Seoul National University Bundang Hospital |
ClinicalTrials.gov Identifier: | NCT01461525 |
Other Study ID Numbers: |
APR-SPS trial |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Low Rectal Cancer Sphincter preservation Abdominoperineal resection Quality of life |
Sexual function Urinary function Oncologic outcome |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |