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

April 18, 2008
September 2, 2014
April 2008
October 2012   (final data collection date for primary outcome measure)
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak [ Time Frame: completion of procedure through 4-12 weeks post procedure ] [ Designated as safety issue: No ]
The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.
  • Determine the clinical and radiologic postoperative anastomotic leak rate in high-risk circular stapled colorectal and coloanal anastomoses using CBSG. [ Time Frame: completion of procedure and follow-up visits ] [ Designated as safety issue: No ]
  • Determine the time to ileostomy closure following diverted high-risk stapled circular colorectal and coloanal anastomoses with and without CBSG [ Time Frame: completion of procedure and follow-up visits ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00663819 on ClinicalTrials.gov Archive Site
  • Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG. [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Provide a Cost/Benefit Analysis With Regard to the Use of CBSG in Stapled Circular Anastomoses [ Time Frame: study completion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Identify and compare the rate of anastomotic stenosis associated with circular stapled anastomoses constructed with and without CBSG. [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Determine the rate of significant staple line hemorrhage with and without the use of CBSG in circular stapled anastomoses [ Time Frame: post operative ] [ Designated as safety issue: No ]
  • Provide a cost/benefit analysis with regard to the use of CBSG in stapled circular anastomoses [ Time Frame: study completion ] [ Designated as safety issue: No ]
  • Determine the efficacy and further substantiate safety of CBSG used in conjunction with circular staplers when performing high-risk colorectal and coloanal anastomoses. [ Time Frame: study completion ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.

This is a randomized prospective trial that compares the use of GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (CBSG) to standard stapling techniques in colorectal resections. The potential exists to utilize CBSG as a means of lowering the rate of post-operative anastomotic leakage and bleeding in high-risk colorectal, coloanal, and ileoanal anastomoses.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rectal Cancer
  • Ulcerative Colitis
  • Familial Adenomatous Polyposis
  • Diverticulitis
  • Device: 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: Staple line without reinforcement
    colorectal and coloanal anastomotic staple line without reinforcement
  • Active Comparator: Device
    GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
    Intervention: Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
  • Procedure/Surgery
    Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
    Intervention: Procedure: Staple line without reinforcement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
258
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who will undergo restorative proctectomy or proctocolectomy (<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis

    , diverticulitis, perforation of the bowel/trauma.

  • Subjects undergoing Hartmann's reversal with restorative proctectomy (<10 cm from the anal verge).
  • Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery.
  • Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer.

Exclusion Criteria:

  • Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease.
  • Subjects who have significant intraoperative hypotension or cardiac events.
  • Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663819
2008-109, CS150
No
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Anthony J Senagore, MD, MBA, MS University of Southern California, Keck School of Medicine
W.L.Gore & Associates
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP