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The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational product group | Experimental | Anti-Adhesion Product was applied to the rectal stump and the incision line. Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. |
|
| Control group | No Intervention | Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Adhesion Product | Biological | Anti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adhesions around the rectal stump and/or incision line |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with no adhesions | ||
| Extent and severity of adhesions around the rectal stump | ||
| Extent and severity of adhesions at the incision line |
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Inclusion Criteria:
Exclusion Criteria:
Pre operative:
Intra operative:
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| Name | Affiliation | Role |
|---|---|---|
| Baxter BioScience Investigator, MD | Baxter Healthcare Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery | Copenhagen | 2120 | Denmark | |||
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| Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line |
| Time to reach and free the rectal stump |
| Safety (laboratory evaluation, recording of adverse experiences) |
| Odense University Hospital, Surgical Gastroenterology Department |
| Odense |
| 5000 |
| Denmark |
| Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM | Warsaw | 00 909 | Poland |
| Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut | Warsaw | 02 781 | Poland |
| Göteborg University, Department of Surgery, Colorectal Unit | Gothenburg | 416 85 | Sweden |
| Söder Sjukhuset, Department of Surgery | Stockholm | 118 83 | Sweden |
| Uddevalla Sjukhus, Kirurg Kliniken | Uddevalla | 451 80 | Sweden |