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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
National Cancer Center, Korea
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang Hospital
Information provided by (Responsible Party):
Sung-Bum Kang, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01461525
First received: October 20, 2011
Last updated: October 4, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Rectal Cancer
Procedure: Abdominoperineal resection
Procedure: Sphincter preservation surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).


Secondary Outcome Measures:
  • Oncologic outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Oncologic outcomes (recurrence, survival)

  • Bladder function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).

  • Sexual function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

  • Anal function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months).


Enrollment: 342
Study Start Date: October 2011
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • APR
  • Miles' operation

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.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461525

Locations
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
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
National Cancer Center, Korea
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang Hospital
Investigators
Principal Investigator: Sung-Bum Kang, Ph. D. Seoul National University Bundang Hospital
  More Information

Responsible Party: Sung-Bum Kang, Director of Colorectal Cancer Center, Principal Investigator, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01461525     History of Changes
Other Study ID Numbers: APR-SPS trial 
Study First Received: October 20, 2011
Last Updated: October 4, 2016
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board
Korea: Ministry for Health and Welfare
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Seoul National University Hospital:
Low Rectal Cancer
Sphincter preservation
Abdominoperineal resection
Quality of life
Sexual function
Urinary function
Oncologic outcome

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on December 02, 2016