Clinical trial · Interventional
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per SAP
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diverticulitis | — | UNRESOLVED | — |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement | Device | — | UNRESOLVED |
| Staple line without reinforcement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Device
- description
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
- interventionNames
- Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
- type
- OTHER
- label
- Procedure/Surgery
- description
- Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
- interventionNames
- Procedure: Staple line without reinforcement
Primary outcomes (1)
- measure
- Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available