Randomized Comparison of Curved Cutter Stapler and Linear Stapler

This study has been completed.

First Received: October 23, 2007 No Changes Posted

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 Surgery

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

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

No publications provided

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

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Rectal Neoplasm

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009