Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial (ASPIRE)

December 2, 2024 updated by: Sung-Bum Kang, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
      • Seoul, Korea, Republic of, 481-10
        • Daehang Hospital
    • Gyeong-gi
      • Anyang, Gyeong-gi, Korea, Republic of, 431-070
        • Hallym University College of Medicine
    • GyeongGi
      • SeongNam, GyeongGi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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:
  • APR
  • Miles' operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life outcome
Time Frame: 3 years
Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncologic outcomes
Time Frame: 5 years
Oncologic outcomes (recurrence, survival)
5 years
Bladder function
Time Frame: 3 years
Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).
3 years
Sexual function
Time Frame: 3 years
Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
3 years
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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Cancer Center, Korea
Seoul National University Bundang Hospital
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang Hospital

Investigators

  • Principal Investigator: Sung-Bum Kang, Ph. D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimated)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR-SPS trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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