Abstract
BackgroundPostoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed.Methods/DesignThis is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part® Gel as an adhesion prophylaxis after major abdominal wall surgery, in comparison to an untreated control group. 60 patients undergoing an elective median laparotomy without prior abdominal surgery are randomly allocated into two groups of a 1:1- ratio. Safety parameter and primary endpoint of the study is the occurrence of wound healing impairment or peritonitis within 28 (+10) days after surgery. The frequency of anastomotic leakage within 28 days after operation, occurrence of adverse and serious adverse events during hospital stay up to 3 months and the rate of adhesions along the scar within 3 months are defined as secondary endpoints. After hospital discharge the investigator will examine the enrolled patients at 28 (+10) days and 3 months (±14 days) after surgery.DiscussionThis trial aims to assess, whether the intra-peritoneal application of A-Part® Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls.Trial registrationNCT00646412
Highlights
Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another
The aim of this study is a first assessment of the safety of A-Part® Gel applied as an adhesion prophylaxis after major abdominal surgery, by specific observation of two major complications of abdominal surgery; wound healing impairment or peritonitis; in comparison to a non treated control group within 28 (+10) days after surgery
There will be a staggering of the treatment of the patients, so that during the early phase of the study there is a one-by one exposure of patients to A-Part® Gel
Summary
Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Adhesions are internal scars developing after trauma and involving the injured tissue and the peritoneum [3]. Depending on the location and the structure of the adhesion serious complications may be caused thereby, such as large and small bowel obstruction. Barrier materials in various forms such as films, viscous gels and intra-peritoneal solutions have been used clinically for the prevention of surgical adhesions. These materials have had limited success, and no treatment is adopted so far as a standard therapy [9]
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