A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil

A Randomized Controlled Trial on the Efficacy and Safety of a New Crosslinked Hyaluronan Gel in Reducing Adhesions after Gynecologic Laparoscopic Surgeries

“…In the contrast, the doses for most site-specific gels are within 40 mL because of safety and/or cost concerns [29,30,34,35,[47][48][49]. Furthermore, the widespread distribution of the gel also possibly could be achieved via intestinal peristalsis and eventually reach broader coverage, similar to that for Intergel [32].…”

“…During 1LL, video recordings were made of 23 anatomic sites designated by the mAFS scoring system and the surgical sites according to protocol before any surgical intervention [31][32][33][34][35][36]. This allowed for a blinded review of the videos and scoring of the number, extent, and severity of adhesions at any of the 23 sites throughout the abdominopelvic cavity (Table S1).…”

“…In accordance with the mAFS scoring system, the following definitions were applied for each anatomic site: adhesion incidence was classified as presence or absence; adhesion severity was classified as mild (i.e., filmy, avascular) or severe (i.e., organized, cohesive, vascular, dense) and scored on a 3-point scale (0, none; 1, mild; 2, severe); and adhesion extent was classified according to the site covered with adhesions as localized (,1/3), moderate (1/3-2/3), or extensive (.2/3) and scored on a 4-point scale (0, none; 1, localized; 2, moderate; 3, extensive) [31][32][33][34][35][36]. Based on their severity and extent, adhesions occurring at each of the 23 or 24 sites were scored as 0 (no adhesion), 1 (severity, mild; extent, localized), 2 (severity, mild; extent, moderate), 4 (severity, mild; extent, extensive or severity, severe; extent, localized), 8 (severity, severe; extent, moderate), or 16 (severity, severe; extent, extensive) [31][32][33][34][35][36].…”

“…Based on their severity and extent, adhesions occurring at each of the 23 or 24 sites were scored as 0 (no adhesion), 1 (severity, mild; extent, localized), 2 (severity, mild; extent, moderate), 4 (severity, mild; extent, extensive or severity, severe; extent, localized), 8 (severity, severe; extent, moderate), or 16 (severity, severe; extent, extensive) [31][32][33][34][35][36].…”

“…Similarly, scores from the 10 sites (ovaries and tubes) were averaged to yield an mAFS score for adnexa [32][33][34][35][36]. Based on mAFS scores (0-16), the adhesion degree was classified into 5 categories: none (0), minimal (.0 and %1), mild (.1 and %4), moderate (.4 and %8), and severe (.8 and %16) [32,33].…”