Stoma reversal
Conditions
Interventions
Follow up:
Clinical assessments will be performed pre-operatively, intra-operatively,
during hospital stay, at discharge from hospital, at 7 days (± 1 days), 30 days
(± 3 days) and 90 days (± 3 days
Sponsors
Cohera Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Be at least 18 years of age; * Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications; * Be scheduled for an ileostomy reversal procedure; * Be willing to follow instructions for incision care; * Agree to return for all follow-up evaluations specified in this protocol; * Sign the informed consent.
Exclusion criteria
Exclusion criteria: * Anesthesia Risk judged to be higher than ASA2 * Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease) * Any condition involving compromised immune system * Any condition known to effect wound healing, such as collagen vascular disease * Known blood clotting disorder * Be receiving antibiotic therapy for pre-existing condition or infection * Concurrent use of fibrin sealants or other anastomosis care devices * Be currently taking systemic steroids or immunosuppressive agents * Have known or suspected allergy or sensitivity to any test materials or reagents * Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints Safety data will be gathered with respect to the number, timing, severity, duration and resolution of device related adverse events occurring among study subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints * Length of hospital stay * Reoperation rate * Readmission rate * Number/type of additional procedures due to complications * Evaluation of the delivery method of the sealant Number of adverse events associated with known complications of ileostomy reversal. Known complications of ileostomy closure include: * Anastomotic leak * Wound infection * Intra-abdominal abscess/sepsis * Small bowel obstruction * Incisional hernia * Prolonged post-operative ileus * Post-operative enterocutaneous fistula | — |
Countries
Netherlands
Outcome results
None listed