Trial Outcomes & Findings for Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses (NCT NCT00663819)

NCT ID: NCT00663819

Last Updated: 2018-04-17

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 258 participants
• Primary outcome timeframe: Completion of procedure through 4-12 weeks post procedure
• Results posted on: 2018-04-17

Participant Flow

Participant milestones

Measure	Device 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 Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Overall Study STARTED	123	135
Overall Study COMPLETED	123	135
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Baseline characteristics by cohort

Measure	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement n=123 Participants 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 n=135 Participants Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement	Total n=258 Participants Total of all reporting groups
Age, Continuous	54.7 years n=5 Participants	56.1 years n=7 Participants	55.4 years n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	42 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	93 Participants n=7 Participants	153 Participants n=5 Participants
Region of Enrollment United States	123 participants n=5 Participants	135 participants n=7 Participants	258 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Device n=123 Participants 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 n=135 Participants Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak	14 Participants	17 Participants

SECONDARY outcome

Timeframe: Post operative

Outcome measures

Measure	Device n=123 Participants 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 n=135 Participants Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.	1 Participants	11 Participants

SECONDARY outcome

Timeframe: Post operative

Outcome measures

Measure	Device n=123 Participants 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 n=135 Participants Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Within 4 - 12 weeks post-surgery

Population: "Significant" Post Operative Complications

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

Outcome measures

Measure	Device n=123 Participants 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 n=135 Participants Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.	13 Participants	10 Participants

Adverse Events

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement

Serious events: 21 serious events

Other events: 16 other events

Deaths: 0 deaths

Procedure/Surgery

Serious events: 28 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement n=123 participants at risk 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 n=135 participants at risk Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Surgical and medical procedures Anastomotic Leak, significant	10.6% 13/123 • Number of events 123 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	7.4% 10/135 • Number of events 135 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Infections and infestations Deep organ space infection	2.4% 3/123 • Number of events 3 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	3.7% 5/135 • Number of events 5 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Infections and infestations Peritonitis	1.6% 2/123 • Number of events 2 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	0.74% 1/135 • Number of events 1 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Gastrointestinal disorders Bowel obstruction	2.4% 3/123 • Number of events 3 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	8.9% 12/135 • Number of events 12 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Gastrointestinal disorders Prolonged ileus	14.6% 18/123 • Number of events 18 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	16.3% 22/135 • Number of events 22 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery

Other adverse events

Measure	GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement n=123 participants at risk 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 n=135 participants at risk Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement
Surgical and medical procedures Anastomotic leak, non-significant	0.81% 1/123 • Number of events 1 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	5.2% 7/135 • Number of events 7 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Infections and infestations Superficial wound infection	8.9% 11/123 • Number of events 11 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	17.0% 23/135 • Number of events 23 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Surgical and medical procedures Anastomotic bleeding	1.6% 2/123 • Number of events 2 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	4.4% 6/135 • Number of events 6 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
General disorders Fistula formation	0.81% 1/123 • Number of events 1 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	1.5% 2/135 • Number of events 2 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery
Surgical and medical procedures Stenosis (stricture)	0.81% 1/123 • Number of events 1 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery	8.1% 11/135 • Number of events 11 • Post operative Day1, Day 3, prior to hospital discharge; at 4 - 12 weeks after surgery; at 90 days post surgery

Additional Information

Dr. Anthony Senagore

CMU College of Medicine

Phone: 989-790-1001

Email: anthony.senagore@cmich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60