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.

Study Overview

• Status: Terminated
• Conditions: Rectal Cancer; Ulcerative Colitis; Familial Adenomatous Polyposis; Diverticulitis
• Intervention / Treatment: Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement; Procedure: Staple line without reinforcement

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.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • University of South Alabama
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California, Keck School of Medicine
  • Florida
    • Weston, Florida, United States, 33331
      • University of South Florida-Cleveland Clinic Florida
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Advocate Healthcare/Good Shepard Hospital
    • Chicago, Illinois, United States, 60612
      • John Stroger Hospital of Cook County
    • Peoria, Illinois, United States, 61606
      • Peoria Surgical Group
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Colon and Rectal Surgery-NEICRS Group
    • Indianapolis, Indiana, United States, 46237
      • Kenderick Regional Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health -Ferguson Group
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Duluth Clinic
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital
    • New York, New York, United States, 10019
      • St. Lukes-Roosevelt Hospital Center
  • Ohio
    • Cleveland, Ohio, United States, 44106-5047
      • University Hospitals of Cleveland, Case Medical Center
  • Texas
    • San Antonio, Texas, United States, 78222
      • Texas Endosurgery Institute
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center and Huntsman Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Device; GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers	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
Other: Procedure/Surgery; Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement	Procedure: Staple line without reinforcement; colorectal and coloanal anastomotic staple line without reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak	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.	Completion of procedure through 4-12 weeks post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.		Post operative
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses		Post operative
Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.	Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.	Within 4 - 12 weeks post-surgery

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Anthony J Senagore, MD, MBA, MS, University of Southern California, Keck School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Rectal Cancer; Proctocolectomy; Anastomosis; Ileostomy; Low anterior colon resection; Proctectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; Adenomatous Polyps; Adenoma; Intestinal Polyposis; Diverticular Diseases; Rectal Neoplasms; Adenomatous Polyposis Coli; Diverticulitis
• Other Study ID Numbers: 2008-109; CS150 (Other Identifier: WL Gore)