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Hum. Reprod. Advance Access published online on December 9, 2004
Human Reproduction, doi:10.1093/humrep/deh651
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Human Reproduction © European Society of Human Reproduction and Embryology 2004; all rights reserved
Received August 8, 2004
Revised September 20, 2004
Accepted October 26, 2004

Article

Clinical evaluation of a viscoelastic gel for reduction of adhesions following gynaecological surgery by laparoscopy in Europe

P. Lundorff 1, J. Donnez 2, M. Korell 3, A.J.M. Audebert 4, K. Block 5, and G.S. diZerega 6*

1 Department of Obstetrics and Gynecology, Viborg Hospital, Viborg, Denmark
2 Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Brussels, Belgium
3 Department of Obstetrics and Gynecology, Klinikum Duisburg, Zuden Rehwiesen 9, Duisburg, Germany
4 Institut Greenblatt France, Bordeaux, France
5 FzioMed Inc., 231 Bonetti Drive, San Luis Obispo, California, USA
6 Obstetrics and Gynecology, Livingston Reproductive Biology Laboratories, Keck-USC School of Medicine, Los Angeles, California, USA

* To whom correspondence should be addressed.
G.S. diZerega, E-mail: GSD1270{at}aol.com


  Abstract

BACKGROUND: Commonly used adhesion prevention devices either cannot be applied or are difficult to use via laparoscopy. A viscoelastic gel was developed specifically for adhesion prophylaxis during minimally invasive surgery. METHODS: Randomized, third party-blinded, parallel-group design conducted at four centres. Patients (18-46 years old) underwent laparoscopic surgery with second look 6-10 weeks later. Viscoelastic gel coated adnexa and adjacent tissues. Blinded reviews of videotapes were quantified by American Fertility Society (AFS) adhesion scores. RESULTS: In 25 treatment patients, surgery was performed on 45 adnexa. Coverage of surgical sites at risk for adhesions was typically accomplished with ~15 ml of viscoelastic gel which was delivered in ~90 s. In 24 control patients, surgery alone was performed on 41 adnexa. Treated adnexa showed a decrease in AFS score (11.9-9.1). In contrast, control adnexa showed an increase in AFS score (8.8-15.8). This difference in second-look AFS scores (42% reduction) is significant (P<0.01). Ninety-three per cent of treated adnexa did not have a worse adhesion score in contrast to 56% of control adnexa. Combining scores into prognostic categories also show significant treatment effect of the viscoelastic gel (P<0.01). CONCLUSION: Viscoelastic gel was easy to use via laparoscopy and produced significant reduction in adnexal adhesions. It provides benefits to patients undergoing gynaecological surgery.

Keywords: adhesions; laparoscopy; Oxiplex; prophylaxis; viscoelastic gel.
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