Reduction of postoperative adhesions with an auto-crosslinked hyaluronan gel in gynaecological laparoscopic surgery: a blinded, controlled, randomized, multicentre study.
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.
Mais
V
V
Division of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, Department of Surgery, Maternal-Fetal Medicine and Imaging, University of Cagliari, Italy. gineca.vmais@tiscali.it
Bracco
G L
GL
Litta
P
P
Gargiulo
T
T
Melis
G B
GB
D000328:Adult; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D010535:Laparoscopy; D007889:Leiomyoma / Q000601:surgery*; D011183:Postoperative Complications / Q000517:prevention & control*; D000267:Tissue Adhesions / Q000517:prevention & control; D016896:Treatment Outcome; D014591:Uterine Diseases / Q000517:prevention & control*; D014594:Uterine Neoplasms / Q000601:surgery*
D005782:Gels; D006820:Hyaluronic Acid