Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

NCT00663819 | Terminated Results

• 2 other identifiers: 2008-109CS150
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 16

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.

Conditions

Rectal Cancer; Ulcerative Colitis; Familial Adenomatous Polyposis; Diverticulitis

Keywords

Low anterior colon resection; Proctectomy; Proctocolectomy; Anastomosis; Rectal Cancer; Ileostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  Within 4 - 12 weeks post-surgery

Study Arms (2)

Device

ACTIVE COMPARATOR

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers

Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement

Procedure/Surgery

OTHER

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

Procedure: Staple line without reinforcement

Interventions

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement DEVICE

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

Device

Staple line without reinforcement PROCEDURE

colorectal and coloanal anastomotic staple line without reinforcement

Procedure/Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (16)

University of South Alabama

Mobile, Alabama, 36617, United States

Location

University of Southern California, Keck School of Medicine

Los Angeles, California, 90033, United States

Location

University of South Florida-Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Advocate Healthcare/Good Shepard Hospital

Barrington, Illinois, 60010, United States

Location

John Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Peoria Surgical Group

Peoria, Illinois, 61606, United States

Location

Colon and Rectal Surgery-NEICRS Group

Fort Wayne, Indiana, 46845, United States

Location

Kenderick Regional Center

Indianapolis, Indiana, 46237, United States

Location

Spectrum Health -Ferguson Group

Grand Rapids, Michigan, 49503, United States

Location

Duluth Clinic

Duluth, Minnesota, 55805, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

St. Lukes-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

University Hospitals of Cleveland, Case Medical Center

Cleveland, Ohio, 44106-5047, United States

Location

Texas Endosurgery Institute

San Antonio, Texas, 78222, United States

Location

University of Utah Health Sciences Center and Huntsman Cancer Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms; Colitis, Ulcerative; Adenomatous Polyposis Coli; Diverticulitis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases; Colonic Diseases; Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diverticular Diseases

Results Point of Contact

• Title: Dr. Anthony Senagore
• Organization: CMU College of Medicine

anthony.senagore@cmich.edu

989-790-1001

Study Officials

• Anthony J Senagore, MD, MBA, MS

  University of Southern California, Keck School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 17, 2018
• Results First Posted: September 10, 2014

Record last verified: 2018-03

Locations

US (16)