Comparative Study of Circular Stapling Instruments | NCT00399009

Studies
Comparative Study of Circular Stapling Instruments

NCT00399009

Sponsor

Uppsala University Hospital

Status

Terminated

Last Update Posted

Jun 9, 2008Estimated

Enrollment

880Estimated

Phase

Not Applicable

Conditions

Anastomotic Leak
Rectal Cancer

Interventions

AutoSuture Premium Plus CEEA/Ethicon Proximate ILS

Countries

Sweden

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Nov 13, 2006

First Submission Date that Met QC Criteria

Nov 13, 2006

First Posted Date

Nov 14, 2006Estimated

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

Jun 5, 2008

Last Update Posted Date

Jun 9, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Uppsala University HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

880Estimated

Name	Type	Description	Arm Group Labels	Other Names
AutoSuture Premium Plus CEEA/Ethicon Proximate ILS	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical anastomotic leak

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18
Anterior resection for Rectal Cancer
Informed consent

Exclusion Criteria:

Can not give informed consent
Patient can not be followed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joakim Folkesson, M.D Ph.D.	Uppsala University	Principal Investigator
Lars Påhlman, Professor M.D. Ph.D.	Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University Hospital		Uppsala		751 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21909698	Derived	Folkesson J, Brown SS, Gunnarsson U, Pahlman L. Randomised multicentre trial of circular stapling devices. Int J Colorectal Dis. 2012 Feb;27(2):227-32. doi: 10.1007/s00384-011-1307-4. Epub 2011 Sep 10.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D015179	Colorectal Neoplasms

ID	Term
D057868	Anastomotic Leak
D012004	Rectal Neoplasms