A safety and efficacy study of a resorbable hydrogel for reduction of post-operative adhesions following myomectomy.
Hum Reprod
; 23(5): 1093-100, 2008 May.
Article
em En
| MEDLINE
| ID: mdl-18346996
ABSTRACT
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 (21) 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.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
2_ODS3
Base de dados:
MEDLINE
Assunto principal:
Polietilenoglicóis
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Complicações Pós-Operatórias
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Aderências Teciduais
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Hidrogéis
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Adult
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Hum Reprod
Ano de publicação:
2008
Tipo de documento:
Article