Department of Gynaecology and Obstetrics, and Pathophysiology of Human Reproduction, University of Naples Federico II, Naples, Italy.
J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):462-9. doi: 10.1016/j.jmig.2011.04.007.
To assess the efficacy of a polyethylene oxide-sodium carboxymethylcellulose gel (Intercoat; Gynecare, division of Ethicon, Inc., Somerville, NJ) in preventing the development of de novo intrauterine adhesions (IUAs) after hysteroscopic surgery and to rate the patency of the internal uterine ostium at 1-month follow-up diagnostic hysteroscopy.
Randomized controlled study (Canadian Task Force classification I).
University hospital.
One hundred ten patients diagnosed during office hysteroscopy as having single or multiple lesions suitable for surgical treatment or resistant dysfunctional uterine bleeding requiring endometrial ablation.
Patients were randomized to 2 groups. Group 1 underwent hysteroscopic surgery plus intrauterine application of Intercoat gel, and group 2 underwent hysteroscopic surgery only (control group). Follow-up office hysteroscopy was performed at 1 month after surgery to assess the rate and severity of IUA formation and to rate the patency of the internal uterine ostium after the surgical intervention.
Compared with the group 2, group 1 demonstrated a significant reduction in the incidence (6% vs 22%; p <.05) of de-novo IUAs. Application of the gel seemed to reduce the severity of IUAs, with fewer moderate and severe IUAs at follow-up in group 1 in comparison with group 2 (33% vs 92%). Furthermore, group 1 demonstrated significant improvement in the degree of patency of the internal uterine ostium (41.9% of cases) in comparison with diagnostic office hysteroscopy performed at enrollment (p <.05). In contrast, in group 2, worsening of patency of the internal uterine ostium was recorded in 18.2% of cases (p <.05).
Intercoat gel seems to prevent de novo formation of IUAs and to improve the patency of the internal uterine ostium at follow-up hysteroscopy. However, larger studies are needed to confirm these findings.
评估聚氧化乙烯-羧甲基纤维素钠凝胶(Intercoat;Gynecare,Ethicon,Inc.的一个部门,新泽西州萨默维尔)在预防宫腔镜手术后新形成的宫腔粘连(IUAs)的疗效,并在术后 1 个月的诊断性宫腔镜随访时评估宫腔内口的通畅性。
随机对照研究(加拿大任务组分类 I)。
大学医院。
110 例在门诊宫腔镜检查中诊断为有单个或多个适合手术治疗的病变或有需要子宫内膜消融术治疗的功能性子宫出血的患者。
患者随机分为 2 组。第 1 组行宫腔镜手术加宫腔内应用 Intercoat 凝胶,第 2 组仅行宫腔镜手术(对照组)。术后 1 个月行门诊宫腔镜检查,评估 IUA 形成的发生率和严重程度,并评估手术干预后宫腔内口的通畅性。
与第 2 组相比,第 1 组新形成的宫腔粘连发生率显著降低(6% vs 22%;p <.05)。与第 2 组相比,第 1 组宫腔粘连的严重程度似乎有所减轻,术后随访时宫腔粘连程度较轻和严重的患者比例较低(33% vs 92%)。此外,与入组时的诊断性门诊宫腔镜检查相比,第 1 组宫腔内口的通畅程度有显著改善(41.9%的病例)(p <.05)。相反,在第 2 组中,18.2%的病例记录到宫腔内口通畅程度恶化(p <.05)。
Intercoat 凝胶似乎可以预防新形成的宫腔粘连,并改善术后宫腔镜随访时宫腔内口的通畅性。然而,需要更大规模的研究来证实这些发现。