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Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study


N/A
18 Years
N/A
Not Enrolling
Both
Ileostomy, When Applicable, Rectal Cancer, When Applicable, Ulcerative Colitis, FAP, Diverticulitis, Hartmann's Reversal

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Trial Information

Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study


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.


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,
FAP, 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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the clinical and radiologic postoperative anastomotic leak rate in high-risk circular stapled colorectal, coloanal,and ileoanal anastomoses using CBSG.

Outcome Time Frame:

completion of procedure and follow-up visits

Safety Issue:

No

Principal Investigator

Anthony J Senagore, MD, MBA, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California, Keck School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

2008-109

NCT ID:

NCT00663819

Start Date:

April 2008

Completion Date:

October 2012

Related Keywords:

  • Ileostomy, When Applicable
  • Rectal Cancer, When Applicable
  • Ulcerative Colitis, FAP, Diverticulitis, Hartmann's Reversal
  • Low anterior colon resection
  • Proctectomy
  • Proctocolectomy
  • Anastomosis
  • Rectal Cancer
  • Ileostomy
  • Rectal Neoplasms
  • Colitis
  • Colitis, Ulcerative
  • Diverticulitis
  • Ulcer

Name

Location

Duluth ClinicDuluth, Minnesota  55805
New York Presbyterian HospitalNew York, New York  10021
University of South AlabamaMobile, Alabama  36693
University of Southern California, Keck School of MedicineLos Angeles, California  90033
Albany Medical CollegeAlbany, New York  
University of South Florida-Cleveland Clinic FloridaWeston, Florida  33331
Advocate Healthcare/Good Shepard HospitalBarrington, Illinois  60010
John Stroger Hospital of Cook CountyChicago, Illinois  60612
Peoria Surgical GroupPeoria, Illinois  61606
Colon and Rectal Surgery-NEICRS GroupFort Wayne, Indiana  46845
Kenderick Regional CenterIndianapolis, Indiana  46237
Spectrum Health -Ferguson GroupGrand Rapids, Michigan  49503
St. Lukes-Roosevelt Hospital CenterNew York, New York  10019
University Hospitals of Cleveland, Case Medical CenterCleveland, Ohio  44106-5047
Texas Endosurgery InstituteSan Antonio, Texas  78222
University of Utah Health Sciences Center and Huntsman Cancer HospitalSalt Lake City, Utah  84132