NCT00549276

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

October 25, 2007

Status Verified

May 1, 2006

First QC Date

October 23, 2007

Last Update Submit

October 23, 2007

Conditions

Rectal NeoplasmSurgical Stapler

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center Sungkyunkwan University School of Medicine,

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Won-Suk Lee, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 25, 2007

Study Start

May 1, 2006

Study Completion

November 1, 2006

Last Updated

October 25, 2007

Record last verified: 2006-05

Locations

KR(1)