间断性宫内气囊疗法预防术后粘连形成的随机对照试验。
Prevention of postoperative adhesion reformation by intermittent intrauterine balloon therapy: a randomised controlled trial.
机构信息
Department of Hysteroscopic Centre, Fuxing Hospital, the Eighth Clinical Medical College, Capital Medical University, Beijing, China.
IVF Unit, Hammersmith Hospital, Imperial College, London, UK.
出版信息
BJOG. 2019 Sep;126(10):1259-1266. doi: 10.1111/1471-0528.15843. Epub 2019 Jul 18.
OBJECTIVE
To compare the efficacy of intermittent intrauterine balloon dilatation versus standard care in the prevention of adhesion reformation.
DESIGN
Single-blind randomised controlled trial.
SETTING
Hysteroscopic Centre of a tertiary University Hospital.
POPULATION
Two hundred patients with moderate to severe (European Society for Gynaecological Endoscopy Grade ≥II) intrauterine adhesions who underwent hysteroscopic adhesiolysis.
METHODS
All participants were randomised to a balloon group or a control group postoperatively. The balloon group received intrauterine balloon dilatation therapy at 2 weeks and 6 weeks after surgery, whereas the control group did not. All patients underwent follow-up hysteroscopy at 4 and 8 weeks postoperatively.
MAIN OUTCOME MEASURES
The adhesion reformation rate and the Pictorial Blood Loss Assessment Chart scores were analysed.
RESULTS
A total of 191 patients successfully completed the study protocol (94 cases for the balloon group and 97 cases for the control group). According to hysteroscopic evaluation at the 8th week, the overall adhesion reformation rate was significantly lower in patients in the balloon group than patients in the control group (20.2% versus 40.2%, respectively; P < 0.05). There was also a significant increase in menstruation flow, as assessed by the Pictorial Blood Loss Assessment Chart score (30 versus 9, respectively; P < 0.001).
CONCLUSIONS
Postoperative intermittent intrauterine balloon dilatation therapy can significantly reduce postoperative adhesion reformation and significantly increase menstruation flow.
TWEETABLE ABSTRACT
RCT: Postoperative intermittent intrauterine balloon therapy can prevent adhesion reformation after hysteroscopic adhesiolysis.
目的
比较间断性宫腔球囊扩张与标准护理预防粘连复发的疗效。
设计
单盲随机对照试验。
地点
三级大学医院宫腔镜中心。
人群
200 例接受宫腔镜粘连松解术的中重度宫腔粘连患者(欧洲妇科内镜学会分级≥Ⅱ级)。
方法
所有患者术后均随机分为球囊组或对照组。球囊组在术后 2 周和 6 周时行宫腔球囊扩张治疗,对照组不行宫腔球囊扩张治疗。所有患者均在术后 4 周和 8 周行宫腔镜随访。
主要观察指标
粘连复发率和 Pictorial Blood Loss Assessment Chart 评分。
结果
共有 191 例患者成功完成研究方案(球囊组 94 例,对照组 97 例)。根据第 8 周宫腔镜评估,球囊组患者的总粘连复发率明显低于对照组(20.2%比 40.2%,P<0.05)。Pictorial Blood Loss Assessment Chart 评分也显示,球囊组的月经出血量明显增加(30 分比 9 分,P<0.001)。
结论
术后间断性宫腔球囊扩张治疗可显著降低术后粘连复发率,显著增加月经量。
推文摘要
RCT:术后宫腔球囊扩张治疗可预防宫腔镜粘连松解术后粘连复发。