Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

This study has been terminated.
(Per SAP)
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00663819
First received: April 18, 2008
Last updated: September 2, 2014
Last verified: September 2014
Results First Received: August 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Rectal Cancer
Ulcerative Colitis
Familial Adenomatous Polyposis
Diverticulitis
Interventions: Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Procedure: Staple line without reinforcement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Device

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

Procedure/Surgery

Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement


Participant Flow:   Overall Study
    Device     Procedure/Surgery  
STARTED     123     135  
COMPLETED     123     135  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients were considered for the study if they were at least 18 years of age and scheduled to undergo one the following (with the anastomosis < 10 cm from the anal verge): low anterior resection, proctectomy, proctocolectomy or a restorative anastomosis by means of Hartmann’s reversal, coloanal anastomosis, or ileo-pouch-anal anastomosis.

Reporting Groups
  Description
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

Procedure/Surgery

Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement

Total Total of all reporting groups

Baseline Measures
    GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement     Procedure/Surgery     Total  
Number of Participants  
[units: participants]
  123     135     258  
Age  
[units: years]
Mean ( Full Range )
  54.7  
  ( 18.8 to 83.8 )  
  56.1  
  ( 21.6 to 82.9 )  
  55.4  
  ( 18.8 to 83.8 )  
Gender  
[units: participants]
     
Female     63     42     105  
Male     60     93     153  
Region of Enrollment  
[units: participants]
     
United States     123     135     258  



  Outcome Measures

1.  Primary:   Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak   [ Time Frame: completion of procedure through 4-12 weeks post procedure ]

2.  Secondary:   Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.   [ Time Frame: post operative ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses   [ Time Frame: post operative ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Provide a Cost/Benefit Analysis With Regard to the Use of CBSG in Stapled Circular Anastomoses   [ Time Frame: study completion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.   [ Time Frame: study completion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anthony Senagore
Organization: CMU College of Medicine
phone: 989-790-1001
e-mail: anthony.senagore@cmich.edu


No publications provided


Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00663819     History of Changes
Other Study ID Numbers: 2008-109, CS150
Study First Received: April 18, 2008
Results First Received: August 21, 2014
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board