Abstract
Postoperative adhesions represent a frequent complication of abdominal surgery. Adhesions can result from infection, ischemia, and foreign body reaction, but commonly develop after any surgical procedure. The morbidity caused by adhesions affects quality of life and, therefore, it is paramount to continue to raise awareness and scientific recognition of the burden of adhesions in healthcare and clinical research. This 2021 Global Expert Consensus Group worked together to produce consented statements to guide future clinical research trials and advise regulatory authorities. It is critical to harmonize the expectations of research, to both develop and bring to market improved anti-adhesion therapies, with the ultimate, shared goal of improved patient outcomes.
Highlights
Postoperative adhesions represent a frequent complication of abdominal surgery
American Fertility Society classification (AFSC) tool could be applied in clinical trial research for adhesion-reducing agents at the time of initial surgery to obtain baseline measurement and again at the time of second-look laparoscopy (SLL)
FDA-approved adhesion prevention products do not target the pathophysiology of adhesion formation and could be associated with reduced efficacy
Summary
Postoperative adhesions represent a frequent complication of abdominal surgery. Adhesions can result from infection, ischemia, and foreign body reaction, but commonly develop after any surgical procedure. Abdominal and pelvic surgeries are the most common cause of peritoneal adhesions and remain a source of considerable morbidity. Voice and perspective (as per the Patient Focused Drug Development initiative launched by the U.S Food and Drug Administration (FDA)); and how clinical researchers may look at advancing the field in assessing how reduction or complete prevention translates to clinically relevant outcomes This consensus document, as an expert opinion paper, offers recommendations on how to conduct clinical drug trial research and defines the components of a strong clinical study design, including relevant primary and secondary endpoints that can be measured in the population within a reasonable period
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