Use of icodextrin 4% solution in the reduction of adhesion formation after gynaecological surgery

Abstract

Our objective was to use Adept Registry for clinical evaluation (ARIEL) to monitor ease of use, acceptability and safety of icodextrin 4% solution during routine gynaecological surgery. Surgeons from six European countries were asked to complete anonymised data collection forms for patients undergoing gynaecological laparoscopy or laparotomy procedures with an associated risk of adhesion formation. Gynaecological surgeons from 150 centres recorded patient demographics, use of icodextrin 4% solution and adverse events, and made subjective assessments of ease of use and patient acceptability with the agent. The gynaecological surgery registry included 2,882 patients; 72% (n = 2,069) underwent laparoscopies. Most surgeons rated the ease of use (viewing of surgical field and handling of tissues) of icodextrin 4% solution as 'excellent' or 'good' and leakage from the surgical site as 'normal' (approximately 60% of laparoscopies and laparotomies) or 'less than normal' (30% and 23%, respectively). Abdominal discomfort was rated by surgeons as 'as expected' in 68% of laparoscopy patients and 67% of laparotomy patients and 'less than expected' in 24% and 26%. Abdominal distension values were comparable. The incidence of adverse events (laparoscopy 7.5%; laparotomy 13.9%) reflected expected rates in gynaecological surgery. ARIEL data indicate that icodextrin 4% solution was well tolerated and easy to use for the reduction of adhesion formation following gynaecological surgery. © Springer-Verlag 2005.