Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00663819
• Collaborator: (none)
• Enrollment: 258
• Locations: 16
• Arms: 2
• Duration (Months): 54
• Patients Per Site: 16.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer; Ulcerative Colitis; Familial Adenomatous Polyposis; Diverticulitis	Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement; Procedure: Staple line without reinforcement	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak [Completion of procedure through 4-12 weeks post procedure]

   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.

Secondary Outcome Measures

1. Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG. [Post operative]

2. Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses [Post operative]

3. 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]

   Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

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

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: Anthony J Senagore, MD, MBA, MS, University of Southern California, Keck School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT00663819
• Other Study ID Numbers: 2008-109; CS150
• First Posted: Apr 22, 2008
• Last Update Posted: Apr 17, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by W.L.Gore & Associates: Low anterior colon resection; Proctectomy; Proctocolectomy; Anastomosis; Rectal Cancer; Ileostomy
• Additional relevant MeSH terms: Rectal Neoplasms; Adenomatous Polyposis Coli; Diverticulitis

Study Results

Participant Flow

Arm/Group Title	Device	Procedure/Surgery
Arm/Group Description	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers 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	Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Period Title: Overall Study
STARTED	123	135
COMPLETED	123	135
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement	Procedure/Surgery	Total
Arm/Group Description	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers 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	Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement	Total of all reporting groups
Overall Participants	123	135	258
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54.7	56.1	55.4
Sex: Female, Male (Count of Participants)
Female	63 51.2%	42 31.1%	105 40.7%
Male	60 48.8%	93 68.9%	153 59.3%
Region of Enrollment (participants) [Number]
United States	123 100%	135 100%	258 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device	Procedure/Surgery
Arm/Group Description	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers 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	Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Measure Participants	123	135
Count of Participants [Participants]	14 11.4%	17 12.6%

2. Secondary Outcome

Title	Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
Time Frame	Post operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device	Procedure/Surgery
Arm/Group Description	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers 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	Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Measure Participants	123	135
Count of Participants [Participants]	1 0.8%	11 8.1%

3. Secondary Outcome

Title	Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
Time Frame	Post operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device	Procedure/Surgery
Arm/Group Description	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers 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	Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Measure Participants	123	135
Count of Participants [Participants]	2 1.6%	6 4.4%

4. Secondary Outcome

Title	Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.
Description	Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.
Time Frame	Within 4 - 12 weeks post-surgery

Outcome Measure Data

Analysis Population Description

"Significant" Post Operative Complications

Arm/Group Title	Device	Procedure/Surgery
Arm/Group Description	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers	Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Measure Participants	123	135
Count of Participants [Participants]	13 10.6%	10 7.4%

Adverse Events

Time Frame	Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Arm/Group Title	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement		Procedure/Surgery
Arm/Group Description	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers 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		Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
All Cause Mortality
	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement		Procedure/Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement		Procedure/Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/123 (17.1%)		28/135 (20.7%)
Gastrointestinal disorders
Bowel obstruction	3/123 (2.4%)	3	12/135 (8.9%)	12
Prolonged ileus	18/123 (14.6%)	18	22/135 (16.3%)	22
Infections and infestations
Deep organ space infection	3/123 (2.4%)	3	5/135 (3.7%)	5
Peritonitis	2/123 (1.6%)	2	1/135 (0.7%)	1
Surgical and medical procedures
Anastomotic Leak, significant	13/123 (10.6%)	123	10/135 (7.4%)	135
Other (Not Including Serious) Adverse Events
	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement		Procedure/Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/123 (13%)		49/135 (36.3%)
General disorders
Fistula formation	1/123 (0.8%)	1	2/135 (1.5%)	2
Infections and infestations
Superficial wound infection	11/123 (8.9%)	11	23/135 (17%)	23
Surgical and medical procedures
Anastomotic leak, non-significant	1/123 (0.8%)	1	7/135 (5.2%)	7
Anastomotic bleeding	2/123 (1.6%)	2	6/135 (4.4%)	6
Stenosis (stricture)	1/123 (0.8%)	1	11/135 (8.1%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.