Rectal CancerASPIRENCT01461525
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
A study testing Abdominoperineal resection and Sphincter preservation surgery in people with Rectal Cancer, run by Seoul National University Hospital at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Abdominoperineal resection and Sphincter preservation surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Oct 2011to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Hallym University College of Medicine
Anyang-si, Gyeonggi-do, 431-070
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Hospital
Seoul, Jongno-gu, 110-744
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
Daehang Hospital
Seoul, 481-10
About this study
Official title: Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Abdominoperineal resection, Sphincter preservation surgery
- Keywords
- Low Rectal Cancer, Sphincter preservation, Abdominoperineal resection, Quality of life, Sexual function, Urinary function, Oncologic outcome
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominoperineal resectionProcedure or surgery
Also called APR, Miles' operation
After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.
Sphincter preservation surgeryProcedure or surgery
Also called SPS
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
| Study group | Role | What they receive |
|---|---|---|
| Sphincter preservation surgery | Experimental | Temporary ileostomy with anal sphincter preservation Receives: Procedure: Sphincter preservation surgery |
| Abdominoperineal Resection | Experimental | Permanent colostomy with total anal sphincter sacrifice Receives: Procedure: Abdominoperineal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life outcome
Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
Measured: 3 years
Secondary outcomes (4)
Oncologic outcomes
Oncologic outcomes (recurrence, survival)
Measured: 5 years
Bladder function
Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).
Measured: 3 years
Sexual function
Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
Measured: 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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital
- Responsible party
- Principal investigator, Sung-Bum Kang, Seoul National University Bundang Hospital
- Investigators
- Sung-Bum Kang, Ph. D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461525
- Sponsor's protocol ID
- APR-SPS trial
- Acronym
- ASPIRE
- Status last verified
- Dec 2024
- First submitted
- 20 Oct 2011
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34327411
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01461525
- Acronym / sponsor ID
- ASPIRE / APR-SPS trial
- Conditions
- Rectal Cancer
- Keywords
- Low Rectal Cancer, Sphincter preservation, Abdominoperineal resection, Quality of life, Sexual function, Urinary function, Oncologic outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital
- Study start
- Oct 2011
- Primary completion
- Aug 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sphincter preservation surgery | Experimental | Procedure: Sphincter preservation surgeryTemporary ileostomy with anal sphincter preservation |
| Abdominoperineal Resection | Experimental | Procedure: Abdominoperineal resectionPermanent colostomy with total anal sphincter sacrifice |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominoperineal resectionAlso: APR, Miles' operationAfter high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy. | Procedure or surgery | Abdominoperineal Resection |
| Sphincter preservation surgeryAlso: SPSAfter 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 | Procedure or surgery | Sphincter preservation surgery |
Primary outcome
Quality of life outcome
Time frame: 3 years
Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
4 secondary outcomes
Oncologic outcomes
Time frame: 5 years
Bladder function
Time frame: 3 years
Sexual function
Time frame: 3 years
Anal function
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 34327411Kang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Bum Kang, Ph. D. principal investigator
Seoul National University Bundang Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominoperineal resection and Sphincter preservation surgery in people with Rectal Cancer, run by Seoul National University Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life outcome (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.