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Randomized Comparison of Curved Cutter Stapler and Linear Stapler

This study has been completed.

Sponsored by: Samsung Medical Center
Information provided by: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00549276
  Purpose

This study aims to compare the safty and technical accessibility of linear stapler and curved cutter stapler during mid to low rectal cancer surgery.


Condition
Rectal Neoplasm
Surgical Stapler

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective

Further study details as provided by Samsung Medical Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Study Start Date:   May 2006
Study Completion Date:   November 2006

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

60 patients were randomly assigned to either linear staplers or the CCS during low anterior resection for mid to low rectal cancers


Criteria

Inclusion Criteria:

  • Biopsy proven adenocarcinoma of rectum.
  • Preoperative stage I-III
  • Patient who is expected to undergo low anterior resection at Samsung Medical Center.
  • Age > 19 years old

Exclusion Criteria:

  • Patient with complicated rectal cancers(obstruction, perforation, abscess)
  • Patient who needs to undergo emergency operation.
  • Patient who can not undergo general anesthesia.
  • Patient who does not agree with the informed consent or does not have the ability to understand content of the trial .
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549276

Locations
Korea, Republic of
Samsung Medical Center Sungkyunkwan University School of Medicine,    
      Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators
Samsung Medical Center

Investigators
Principal Investigator:     Won-Suk Lee, M.D.     Samsung Medical Center    
  More Information


Study ID Numbers:   Samsung Medical Center
First Received:   October 23, 2007
Last Updated:   October 23, 2007
ClinicalTrials.gov Identifier:   NCT00549276
Health Authority:   Korea: Food and Drug Administration

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Rectal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 17, 2008




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