Randomized Comparison of Curved Cutter Stapler and Linear... | NCT00549276

Studies
Randomized Comparison of Curved Cutter Stapler and Linear Stapler

NCT00549276

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Oct 25, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Rectal Neoplasm
Surgical Stapler

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Oct 23, 2007

First Submission Date that Met QC Criteria

Oct 23, 2007

First Posted Date

Oct 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2007

Last Update Posted Date

Oct 25, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility 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 .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Won-Suk Lee, M.D.	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center Sungkyunkwan University School of Medicine,		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided