Abdominal Adhesions
Conditions
Brief summary
This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.
Interventions
DEVICESepraspray
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.
Exclusion criteria
* Patients who are pregnant. * Patients with ongoing abdominal abscess. * Patients with ongoing bacterial peritonitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision | 8-14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision. | 8-14 weeks |
| Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications. | 8-14 weeks |
Countries
Czechia, Denmark, France, Germany, United Kingdom
Outcome results
None listed