Diverticulitis, Familial Adenomatous Polyposis, Rectal Cancer, Ulcerative Colitis
Conditions
Keywords
Low anterior colon resection, Proctectomy, Proctocolectomy, Anastomosis, Rectal Cancer, Ileostomy
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.
Interventions
DEVICEGORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
PROCEDUREStaple line without reinforcement
colorectal and coloanal anastomotic staple line without reinforcement
Sponsors
W.L.Gore & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement 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 | 123 |
| 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 | 135 |
| Total | 258 |
Baseline characteristics
| Characteristic | Total | GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement | Procedure/Surgery |
|---|---|---|---|
| Age, Continuous | 55.4 years | 54.7 years | 56.1 years |
| Region of Enrollment United States | 258 participants | 123 participants | 135 participants |
| Sex: Female, Male Female | 105 Participants | 63 Participants | 42 Participants |
| Sex: Female, Male Male | 153 Participants | 60 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 123 | 49 / 135 |
| serious Total, serious adverse events | 21 / 123 | 28 / 135 |
Outcome results
Primary
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.
Time frame: Completion of procedure through 4-12 weeks post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak | 14 Participants |
| Procedure/Surgery | Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak | 17 Participants |
Secondary
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.
Time frame: Within 4 - 12 weeks post-surgery
Population: Significant Post Operative Complications
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | 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 |
| Procedure/Surgery | Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses. | 10 Participants |
Secondary
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
Time frame: Post operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses | 2 Participants |
| Procedure/Surgery | Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses | 6 Participants |
Secondary
Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
Time frame: Post operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device | Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG. | 1 Participants |
| Procedure/Surgery | Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG. | 11 Participants |