Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Study Overview
=================
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.

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

Conditions
-----------------
Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis

Intervention / Treatment
-----------------
* Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
* Procedure: Staple line without reinforcement


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device<br>GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers | Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement<br>* Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler<br>|
| Other: Procedure/Surgery<br>Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement | Procedure: Staple line without reinforcement<br>* colorectal and coloanal anastomotic staple line without reinforcement<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proctectomy, Low anterior colon resection, Proctocolectomy, Anastomosis, Rectal Cancer, Ileostomy