Hum. Reprod. Advance Access originally published online on March 17, 2008
Human Reproduction 2008 23(5):1093-1100; doi:10.1093/humrep/den080
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A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy
1 Department of Obstetrics and Gynecology, University Clinics of Schleswig-Holstein, Campus Kiel, Michaelisstrasse 16, 24105 Kiel, Germany 2 Bethesda Krankenhaus Wuppertal, 42109 Wuppertal, Germany 3 Klinik für Minimal Invasive Chirurgie, 14129 Berlin, Germany 4 Universitätsklinikum Giessen, D-35385 Giessen, Germany 5 Obstetrics and Gynecology, St Joseph's Health Centre, Toronto, Ontario, Canada M6R 3B2 6 Medical Affairs, Angiotech Pharmaceuticals, Inc., Vancouver, British Columbia, Canada V6A 1B6
7 Correspondence address. Tel: +49-431597-2086; Fax: +49-431597-2116; E-mail: endo-office{at}email.uni-kiel.de; lmettler{at}email.uni-kiel.de
BACKGROUND: This multicenter, randomized, single-blind study assessed the safety and efficacy of a resorbable hydrogel (‘Hydrogel’) for the reduction of post-operative adhesion formation following myomectomy.
METHODS: Women (n = 71) who were undergoing laparoscopic (67.6%) or laparotomic myomectomy were randomized (2:1) to Hydrogel (sprayed over surgically treated areas prior to wound closure, n = 48) or to control (standard care, n = 23). Patients (38 Hydrogel, 20 control) returned 8–10 weeks later for a second look. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method. The primary efficacy measure was the posterior uterus mAFS score.
RESULTS: For Hydrogel and control patients, respectively, mean ± SD mAFS scores were 0.5 ± 1.4 and 0.0 ± 0.0 at baseline, and 1.1 ± 1.9 and 2.6 ± 2.2 at the second look. Similarly, mean changes from baseline were 0.8 ± 2.0 and 2.6 ± 2.2 (P = 0.01); 95% confidence intervals for these mean changes were (0.16–1.44) and (1.64–3.56). Adverse events were reported by 9.6 and 17.4% of Hydrogel and control patients, respectively. No intra-abdominal infections or post-operative site infections were reported.
CONCLUSIONS: This 71-patient study provides the first clinical evidence of the safety and efficacy of Hydrogel for the reduction of adhesions following myomectomy.
The ClinicalTrials.gov Identifier is NCT00562471 [ClinicalTrials.gov] .
Key words: adhesions/gynecologic surgery/laparoscopy/laparotomy/polyethylene glycol
These data were presented at the 19th European Congress of Obstetrics and Gynecology (EBCOG) meeting, 5–8 April 2006 in Torino, Italy. Submitted on July 18, 2007; resubmitted on January 22, 2008; accepted on February 22, 2008.