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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
46
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.
Copenhagen University Hospital, Rigshospitalet Department of Gastroenterologic Surgery
Copenhagen, Denmark
Odense University Hospital, Surgical Gastroenterology Department
Odense, Denmark
Klinika Chirurgii Ogolnej Onkologicznej i Klatiki Piersiowej CSK WAM
Warsaw, Poland
Im. Marii Sklodowskiej-Curie, Centrum Onkologii-Instytut
Warsaw, Poland
Göteborg University, Department of Surgery, Colorectal Unit
Gothenburg, Sweden
Söder Sjukhuset, Department of Surgery
Stockholm, Sweden
Uddevalla Sjukhus, Kirurg Kliniken
Uddevalla, Sweden
Incidence of adhesions around the rectal stump and/or incision line
Number of subjects with no adhesions
Extent and severity of adhesions around the rectal stump
Extent and severity of adhesions at the incision line
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)
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