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

NCT ID: NCT01461525

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2020-06-30

Brief Summary

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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

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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

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Rectal Cancer

Keywords

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Low Rectal Cancer Sphincter preservation Abdominoperineal resection Quality of life Sexual function Urinary function Oncologic outcome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sphincter preservation surgery

Temporary ileostomy with anal sphincter preservation

Group Type EXPERIMENTAL

Sphincter preservation surgery

Intervention Type PROCEDURE

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

Abdominoperineal Resection

Permanent colostomy with total anal sphincter sacrifice

Group Type EXPERIMENTAL

Abdominoperineal resection

Intervention Type PROCEDURE

After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.

Interventions

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Abdominoperineal resection

After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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APR Miles' operation SPS

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Boramae Hospital

OTHER

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role collaborator

Daehang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung-Bum Kang

Director of Colorectal Cancer Center, Principal Investigator, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung-Bum Kang, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Hallym University College of Medicine

Anyang-si, Gyeonggi-do, South Korea

Site Status

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Daehang Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 34327411 (View on PubMed)

Other Identifiers

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APR-SPS trial

Identifier Type: -

Identifier Source: org_study_id