welcome to oneFAPvoice

- a positively charged Familial Adenomatous Polyposis community.

join today!
login

terminated

Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

key information

study id #: NCT00663819

condition: Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis

status: terminated

purpose:

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.

intervention:
Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Procedure: Staple line without reinforcement

study details

start date: April 2008

estimated completion: October 2012

last updated: April 17, 2018

phase of development: Not Available

size / enrollment: 258

study design:
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

study 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.

primary outcomes:

Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak [ Time Frame: completion of procedure through 4-12 weeks post procedure ] [ Designated as safety issue: No ]
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 outcomes:

Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG. [ Time Frame: post operative ] [ Designated as safety issue: No ]
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses [ Time Frame: post operative ] [ Designated as safety issue: No ]
Provide a Cost/Benefit Analysis With Regard to the Use of CBSG in Stapled Circular Anastomoses [ Time Frame: study completion ] [ Designated as safety issue: No ]
Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses. [ Time Frame: study completion ] [ Designated as safety issue: No ]

inclusion criteria:

• Eligible Sexes:

- 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 contacts

expertly curated content related to this topic

evidence & education

Severe Duodenal Involvement in Familial Adenomatous Polyposis Treated by Pylorus-Preserving Pancreaticoduodenectomy
PURPOSE : Pancreaticoduodenectomy is an ...
news & meetings

Vitamin D3 and Metformin Show Promising Results in Preventing Colorectal Cancer
...
evidence & education

Evaluation of 28 Years of Surgical Treatment of Children and Young Adults with Familial Adenomatous Polyposis
BACKGROUND : In this retrospective study...
evidence & education

Proctocolectomy for Colorectal Cancer–Is the Ileal Pouch Anal Anastomosis a Safe Alternative to Permanent Ileo...
PURPOSE : Ileal pouch anal anastomosis (...
rareHub

Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
Total proctocolectomy with ileal pouch a...
evidence & education

Efficacy of pancreatic enzyme replacement therapy in chronic pancreatitis: systematic review and meta-analysis
Objective The benefits of pancreatic ...
news & meetings

Safety & Efficacy of Phase-3 Placebo Trial of Celecoxib
...

evidence & education

scientific literature & patient education texts

people & places

healthcare providers, researchers & advocates

news & meetings

latest announcements & gatherings

videos & visuals

online channels, infographics & slides

rareHub

access clinical trials worldwide

trial finder

get matched with clinical trials

recruiting near me

geolocate centers seeking participants

education center

learn clinical trial basics and beyond

protocol partners

help shape future clinical research

rareCurate

evidence & education

people & places

news & meetings

videos & visuals

rareClinical

rareHub

trial finder

recruiting near me

education center

protocol partners

welcome to oneFAPvoice

rareHub

trial finder

recruiting near me

education center

protocol partners

Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

expertly curated content related to this topic

rareCurate

evidence & education

people & places

social & media

news & meetings

videos & visuals

rareClinical

rareHub

trial finder

recruiting near me

education center

protocol partners

welcome to oneFAPvoice

rareHub

trial finder

recruiting near me

education center

protocol partners

Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

expertly curated content related to this topic