WOMENS-HEALTH Messages for June, 2008: FIBROIDS: Resorbable hydrogel for reduction of adhesions following myomectomy

FIBROIDS: Resorbable hydrogel for reduction of adhesions following myomectomy

From: Hope Waltman (anonymous@obgyn.net)
Sat, 7 Jun 2008 18:46:04 -0500 (CDT)

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Hum Reprod. 2008 May;23(5):1093-100. Epub 2008 Mar 17. Links

A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy. Mettler L, Hucke J, Bojahr B, Tinneberg HR, Leyland N, Avelar R.

"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." http://www.ncbi.nlm.nih.gov/pubmed/18346996?dopt=AbstractPlus

Regards, Hope Waltman, Fibroid Forum and WH Forum Moderator

http://www.hopeforfibroids.org http://www.doctorsinfoweb.com/doctors.htm UTERINE FIBROIDS INFO: http://www.obgyn.net/fibroid-resource-center/

http://www.obgyn.net/fibroid-resource-center/?page=articles/patient_articles

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