Clinical trial NCT00663819: Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
Official title: Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Ulcerative Colitis
Familial Adenomatous Polyposis
Diverticulitis
Keywords: Low anterior colon resection
Proctectomy
Proctocolectomy
Anastomosis
Rectal Cancer
Ileostomy
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
timeFrame: Completion of procedure through 4-12 weeks post procedure
Secondary outcomes:
measure: Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
timeFrame: Post operative
measure: Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
timeFrame: Post operative
measure: Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.
timeFrame: Within 4 - 12 weeks post-surgery
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California, Keck School of Medicine
state: California
city: Weston
country: United States
facility: University of South Florida-Cleveland Clinic Florida
state: Florida
city: Barrington
country: United States
facility: Advocate Healthcare/Good Shepard Hospital
state: Illinois
city: Chicago
country: United States
facility: John Stroger Hospital of Cook County
state: Illinois
city: Peoria
country: United States
facility: Peoria Surgical Group
state: Illinois
city: Fort Wayne
country: United States
facility: Colon and Rectal Surgery-NEICRS Group
state: Indiana
city: Indianapolis
country: United States
facility: Kenderick Regional Center
state: Indiana
city: Grand Rapids
country: United States
facility: Spectrum Health -Ferguson Group
state: Michigan
city: Duluth
country: United States
facility: Duluth Clinic
state: Minnesota
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: St. Lukes-Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Case Medical Center
state: Ohio
city: San Antonio
country: United States
facility: Texas Endosurgery Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center and Huntsman Cancer Hospital
state: Utah
Study officials:
affiliation: University of Southern California, Keck School of Medicine
name: Anthony J Senagore, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
References: