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

NCT01461525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Abdominoperineal resection

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

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

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Seoul National University Boramae Hospital

    collaborator OTHER

  • Hallym University Medical Center

    collaborator OTHER

  • Daehang Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Sung-Bum Kang, Ph. D. · Seoul National University Bundang Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2019-08-31
Completion
2020-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01461525 on ClinicalTrials.gov