Randomized Comparison of Curved Cutter Stapler and Linear Stapler

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00549276
First received: October 23, 2007
Last updated: NA
Last verified: May 2006
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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
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: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on July 31, 2014