Hum. Reprod. Advance Access published online on January 26, 2006
Human Reproduction, doi:10.1093/humrep/dei488
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1 Division of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, Department of Surgery, Maternal-Fetal Medicine and Imaging, University of Cagliari, Ospedale S. Giovanni di Dio, Cagliari, Italy
* To whom correspondence should be addressed. BACKGROUND: Following myomectomy, postoperative adhesions occur in many patients with adverse effects on fertility. This study investigated the applicability, safety and efficacy of an auto-crosslinked hyaluronan gel in preventing adhesion formation after laparoscopic myomectomy. METHODS: Fifty-two patients aged 22-42 years, undergoing surgery at four centres, were randomly allocated to receive either the gel or no adhesion prevention. The incidence and severity of postoperative adhesions were assessed laparoscopically after 12-14 weeks in a blinded, scored fashion. The primary efficacy variable was the presence/absence of postoperative adhesions at second-look. RESULTS: A nonsignificantly higher proportion of patients receiving the gel were free from adhesions (13 of 21; 62%) compared with control patients (9 of 22; 41%), with a statistically significant difference between the severity of uterine adhesions at baseline and at second-look (0.3 ± 0.9 versus 0.8 ± 1.0, P < 0.05). In subjects undergoing myomectomy without concomitant surgery, the proportion of adhesion-free patients was 8 of 12 (67%) and 4 of 11 (36%) (not significant) in the gel and control groups, respectively, with a significant difference in the mean severity scores (P < 0.05). In subjects without uterine adhesions before myomectomy, 12 of 18 (67%) and 8 of 20 (40%) patients in the gel and control groups, respectively were adhesion-free (not significant), with a significant difference in the severity of uterine adhesions (P = 0.05). CONCLUSIONS: Our results suggest that the auto-crosslinked hyaluronan gel may have a favourable safety profile and efficacious antiadhesive action following laparoscopic myomectomy.
Received May 16, 2005
Revised October 4, 2005
Accepted December 14, 2005
Article
Reduction of postoperative adhesions with an auto-crosslinked hyaluronan gel in gynaecological laparoscopic surgery: a blinded, controlled, randomized, multicentre study
V. Mais 1,
G.L. Bracco 2,
P. Litta 3,
T. Gargiulo 4,
and
G.B. Melis 1 *
2 Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Florence
3 Department of Human Reproduction Sciences, 2nd Gynecology Clinic, University of Padua, Padua
4 Department of Obstetrics and Gynecology, Ospedale Maria Vittoria, Corso Tassoni, Turin, Italy
G.B. Melis, E-mail: gineca.vmais{at}tiscali.it
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