Rectal CancerNCT00663819
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
A study testing GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement and Staple line without reinforcement in people with Rectal Cancer and Ulcerative Colitis, run by W.L.Gore & Associates at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis
- What is being tested?
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement and Staple line without reinforcement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2008to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Albany Medical College
Albany, New York, 12208
Advocate Healthcare/Good Shepard Hospital
Barrington, Illinois, 60010
John Stroger Hospital of Cook County
Chicago, Illinois, 60612
University Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, 44106-5047
Duluth Clinic
Duluth, Minnesota, 55805
Colon and Rectal Surgery-NEICRS Group
Fort Wayne, Indiana, 46845
Spectrum Health -Ferguson Group
Grand Rapids, Michigan, 49503
Kenderick Regional Center
Indianapolis, Indiana, 46237
University of Southern California, Keck School of Medicine
Los Angeles, California, 90033
University of South Alabama
Mobile, Alabama, 36617
St. Lukes-Roosevelt Hospital Center
New York, New York, 10019
New York Presbyterian Hospital
New York, New York, 10032
Peoria Surgical Group
Peoria, Illinois, 61606
University of Utah Health Sciences Center and Huntsman Cancer Hospital
Salt Lake City, Utah, 84132
Texas Endosurgery Institute
San Antonio, Texas, 78222
University of South Florida-Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
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.
Read the 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.
- Being tested
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Keywords
- Low anterior colon resection, Proctectomy, Proctocolectomy, Anastomosis, Rectal Cancer, Ileostomy
- Medical subject headings
- Rectal Neoplasms, Colitis, Ulcerative, Adenomatous Polyposis Coli, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE SEAMGUARD® Bioabsorbable Staple Line ReinforcementDevice
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
Staple line without reinforcementProcedure or surgery
colorectal and coloanal anastomotic staple line without reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Device | Active comparator | GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers Receives: Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement |
| Procedure/Surgery | Other | Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement Receives: Procedure: Staple line without reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post operative
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
Measured: 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.
Measured: Within 4 - 12 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Per SAP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony J Senagore, MD, MBA, MS, Principal investigator, University of Southern California, Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663819
- Sponsor's protocol ID
- 2008-109
- Other IDs
- CS150
- Status last verified
- Mar 2018
- First submitted
- 18 Apr 2008
- Last updated
- 17 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00663819
- Acronym / sponsor ID
- 2008-109
- Keywords
- Low anterior colon resection, Proctectomy, Proctocolectomy, Anastomosis, Rectal Cancer, Ileostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per SAP
- Enrolment
- 258 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 10 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Active comparator | Device: GORE SEAMGUARD® Bioabsorbable Staple Line ReinforcementGORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers |
| Procedure/Surgery | Other | Procedure: Staple line without reinforcementProcedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GORE SEAMGUARD® Bioabsorbable Staple Line ReinforcementColorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler | Device | Device |
| Staple line without reinforcementcolorectal and coloanal anastomotic staple line without reinforcement | Procedure or surgery | Procedure/Surgery |
Primary outcome
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
Time frame: 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.
3 secondary outcomes
Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
Time frame: Post operative
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
Time frame: 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.
Time frame: Within 4 - 12 weeks post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony J Senagore, MD, MBA, MS principal investigator
University of Southern California, Keck School of Medicine
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement and Staple line without reinforcement in people with Rectal Cancer and Ulcerative Colitis, run by W.L.Gore & Associates at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak (time frame: Completion of procedure through 4-12 weeks post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.