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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Abdominoperineal resection
Sphincter preservation surgery
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Low Rectal Cancer, Sphincter preservation, Abdominoperineal resection, Quality of life, Sexual function, Urinary function, Oncologic outcome

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hallym University College of Medicine
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Daehang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sphincter preservation surgery

Abdominoperineal Resection

Arm Description

Temporary ileostomy with anal sphincter preservation

Permanent colostomy with total anal sphincter sacrifice

Outcomes

Primary Outcome Measures

Quality of life outcome
Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

Secondary Outcome Measures

Oncologic outcomes
Oncologic outcomes (recurrence, survival)
Bladder function
Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).
Sexual function
Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
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).

Full Information

First Posted
October 20, 2011
Last Updated
October 20, 2020
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01461525
Brief Title
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial
Acronym
ASPIRE
Official Title
Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Low Rectal Cancer, Sphincter preservation, Abdominoperineal resection, Quality of life, Sexual function, Urinary function, Oncologic outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sphincter preservation surgery
Arm Type
Experimental
Arm Description
Temporary ileostomy with anal sphincter preservation
Arm Title
Abdominoperineal Resection
Arm Type
Experimental
Arm Description
Permanent colostomy with total anal sphincter sacrifice
Intervention Type
Procedure
Intervention Name(s)
Abdominoperineal resection
Other Intervention Name(s)
APR, Miles' operation
Intervention Description
After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.
Intervention Type
Procedure
Intervention Name(s)
Sphincter preservation surgery
Other Intervention Name(s)
SPS
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of life outcome
Description
Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Oncologic outcomes
Description
Oncologic outcomes (recurrence, survival)
Time Frame
5 years
Title
Bladder function
Description
Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).
Time Frame
3 years
Title
Sexual function
Description
Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
Time Frame
3 years
Title
Anal function
Description
Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months).
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Bum Kang, Ph. D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University College of Medicine
City
Anyang
State/Province
Gyeong-gi
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
SeongNam
State/Province
GyeongGi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Daehang Hospital
City
Seoul
ZIP/Postal Code
481-10
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34327411
Citation
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.
Results Reference
derived

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

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