Objective: To evaluate the efficacy and safety of Adept (4% icodextrin solution) in reducing adhesions after laparoscopic gynecological surgery involving adhesiolysis.
Design: Multicenter, prospective, randomized, double-blind study comparing Adept with lactated Ringer's solution (LRS).
Patient(s): Four hundred two patients randomized intraoperatively to Adept (n = 203) or LRS (n = 199) returned for second laparoscopy within 4-8 weeks. Incidence, severity, and extent of adhesions were determined on both occasions.
Main outcome measure(s): The primary efficacy measure defined by the Food and Drug Administration was the number of patients achieving clinical success with adhesion treatment. Other measures included incidence and American Fertility Society (AFS) scores.
Result(s): Significantly more Adept patients achieved clinical success than did LRS patients (49% vs. 38%). In infertility patients, Adept demonstrated particular clinical success compared with LRS (55% vs. 33%). This was reflected in the number of patients with a reduced AFS score (53% vs. 30%) and in fewer patients with a moderate/severe AFS category score (43% vs. 14%). Safety was comparable in both groups. Most events were related to the surgery, with an increase in transient labial edema in the Adept group.
Conclusion(s): This is the first randomized, double-blind trial of an adhesion reduction agent. It demonstrated that Adept is a safe and effective adhesion reduction agent in laparoscopy.