Randomized Comparison of Curved Cutter Stapler and Linear Stapler

Rectal Neoplasm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549276
• Other study ID #: Samsung Medical Center
• Status: Completed
• Phase: N/A
• First received: October 23, 2007
• Last updated: October 23, 2007
• Start date: May 2006
• Est. completion date: November 2006

Study information

• Verified date: May 2006
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 .

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Neoplasm
• Rectal Neoplasms
• Surgical Stapler

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center Sungkyunkwan University School of Medicine,	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of,