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. 2022 Nov 28;47(11):1575-1585.
doi: 10.11817/j.issn.1672-7347.2022.220340.

Clinical study on 2 types of intrauterine stents with different thickness and hardness in the treatment of moderate-to-severe intrauterine adhesions

[Article in English, Chinese]
Huan Huang  1 , Xuetao Mao  2 , Yang Yu  3 , Bingxin Xiao  3 , Xingping Zhao  3 , Aiqian Zhang  4 , Dabao Xu  5
Affiliations

Clinical study on 2 types of intrauterine stents with different thickness and hardness in the treatment of moderate-to-severe intrauterine adhesions

[Article in English, Chinese]
Huan Huang et al. Zhong Nan Da Xue Xue Bao Yi Xue Ban. .

Abstract
in English, Chinese, Chinese

Objectives: Although hysteroscopic adhesiolysis (HA) is the main treatment for intrauterine adhesion (IUA), postoperative management of IUA remains challenging because there is no consensus on how to mitigate the high rate of postoperative adhesions reformation. This study aims to compare the effectiveness and safety of 2 types of intrauterine stents with different thickness and hardness in treating moderate-to-severe IUA.

Methods: A retrospective clinical study was conducted in the Third Xiangya Hospital of Central South University from November 2020 to July 2021. A total of 191 patients with moderate-to-severe IUA who received surgical treatment and placed intrauterine stents after HA to prevent recurrence of postoperative adhesions were included. According to the hardness and thickness of the intrauterine stents, the participants were divided into a case group (placed the novel thin intrauterine stent, n=62) and a control group (placed the conventional stent, n=129). After 2-3 menstrual cycles, a second-look hysteroscopy was performed, and the intrauterine stents were removed. The postoperative efficacy [the reduction of American Fertility Society (AFS) scores, the adhesions reformation rate, the changes in menstrual pattern, and the pregnancy rate during the follow-up], safety (the adverse events), and applicability (the difficulty of stent removal) were compared between the 2 groups.

Results: No significant differences in preoperative clinical characteristics were observed between the 2 groups (all P>0.05). The menstrual volume of all patients was increased after the treatment. The reduction of AFS scores and the menstruation recovery rate were not significantly different between the 2 groups (P=0.519 and P=0.272, respectively). Notably, there was no case of displacement in the case group, while the displacement rate of the control group was 2.3% (P=0.552). Moreover, there was no significant difference in abdominal pain or postoperative abnormal vaginal bleeding between the 2 groups (P=0.823 and P=0.851, respectively). However, the difficulty rate of removing the thinner stents was significantly lower than that of removing the traditional stent (21.0% vs 38.8%, P=0.014). During the follow-up for half a year of the postoperative period, the pregnancy rate did not differ significantly in the case and control groups (45.0% vs 34.6%, P=0.173).

Conclusions: The novel intrauterine stent shows noninferior efficacy and had a good safety profile compared with conventional stents in treating moderate-to-severe IUA. Importantly, it was more convenient to be removed without increasing the rate of displacement and detachment. Therefore, it could reduce the amount of damage to the endometrium and has higher applicability than conventional stents.

目的: 宫腔镜下宫腔粘连分离术(hysteroscopic adhesiolysis，HA)是宫腔粘连(intrauterine adhesion，IUA)的主要治疗方法，但IUA术后管理仍然具有挑战性，主要在如何处理术后粘连高复发率的问题上缺乏共识。本研究旨在比较两种不同厚度和硬度的宫腔支架治疗中重度宫腔粘连的有效性和安全性。方法: 选择2020年11月至2021年7月在中南大学湘雅三医院接受手术治疗并于术后放置宫腔支架以防止术后粘连再发的中重度宫腔粘连患者191例进行回顾性研究。根据放置宫腔支架的厚度与硬度不同，分为研究组(放置新型宫腔支架，n=62)和对照组(放置传统宫腔支架组，n=129)，2~3个月经周期后再次行宫腔镜探查并取出宫腔支架。比较两组患者的术后疗效[美国生育学会(American Fertility Society，AFS)评分下降程度、再粘连发生率、月经改善情况、随访期间的妊娠情况]、安全性(支架放置后的不良反应)和适用性(取出支架的难度)。结果: 2组间术前基线临床特征差异无统计学意义(均P>0.05)。所有患者治疗后月经量均增多。AFS分数的下降程度和月经恢复率2组间差异无统计学意义(分别P=0.519和 P=0.272)。研究组无支架移位发生，而对照组支架移位率为2.3%，但差异无统计学意义(P=0.552)。2组术后腹痛和异常阴道出血发生率差异无统计学意义(分别P=0.82和P=0.851)。新型支架较传统支架更容易取出(21.0% vs 38.8%，P=0.014)。支架取出后随访半年，2组妊娠率差异无统计学意义(45.0% vs 34.6%，P=0.173)。结论: 新款薄型支架用于治疗中重度宫腔粘连疗效不劣于传统宫腔支架，有较好的安全性并具有独特优势，即在不增加移位、脱落率的同时取出更加方便，因而能减少对子宫内膜的再次损伤，具有更好的临床适用性。.

目的: 宫腔镜下宫腔粘连分离术(hysteroscopic adhesiolysis，HA)是宫腔粘连(intrauterine adhesion，IUA)的主要治疗方法，但IUA术后管理仍然具有挑战性，主要在如何处理术后粘连高复发率的问题上缺乏共识。本研究旨在比较两种不同厚度和硬度的宫腔支架治疗中重度宫腔粘连的有效性和安全性。

方法: 选择2020年11月至2021年7月在中南大学湘雅三医院接受手术治疗并于术后放置宫腔支架以防止术后粘连再发的中重度宫腔粘连患者191例进行回顾性研究。根据放置宫腔支架的厚度与硬度不同，分为研究组(放置新型宫腔支架，n=62)和对照组(放置传统宫腔支架组，n=129)，2~3个月经周期后再次行宫腔镜探查并取出宫腔支架。比较两组患者的术后疗效[美国生育学会(American Fertility Society，AFS)评分下降程度、再粘连发生率、月经改善情况、随访期间的妊娠情况]、安全性(支架放置后的不良反应)和适用性(取出支架的难度)。

结果: 2组间术前基线临床特征差异无统计学意义(均P>0.05)。所有患者治疗后月经量均增多。AFS分数的下降程度和月经恢复率2组间差异无统计学意义(分别P=0.519和 P=0.272)。研究组无支架移位发生，而对照组支架移位率为2.3%，但差异无统计学意义(P=0.552)。2组术后腹痛和异常阴道出血发生率差异无统计学意义(分别P=0.82和P=0.851)。新型支架较传统支架更容易取出(21.0% vs 38.8%，P=0.014)。支架取出后随访半年，2组妊娠率差异无统计学意义(45.0% vs 34.6%，P=0.173)。

结论: 新款薄型支架用于治疗中重度宫腔粘连疗效不劣于传统宫腔支架，有较好的安全性并具有独特优势，即在不增加移位、脱落率的同时取出更加方便，因而能减少对子宫内膜的再次损伤，具有更好的临床适用性。

Keywords: hysteroscopic adhesiolysis; intrauterine adhesions; intrauterine stent.

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Conflict of interest statement

The authors declare that they have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1. Flowchart of the study population HA: Hysteroscopic adhesiolysis.
Figure 2
Figure 2. Structure of the 2 types of intrauterine stents
A: Conventional stent; B: Novel stent.
Figure 3
Figure 3. Three-dimensional transvaginal ultrasound (3D-TVUS) showing the position of the intrauterine stent in uterine cavity after surgery
A: Normal position of the intrauterine stent; B: Displacement of one conventional stent into the cervix.
Figure 4
Figure 4. Hysteroscopy images of cervical canal
A: Cervical canal adhesions before hysteroscopic adhesiolysis is shown. B: Stent tail is shown to prevent cervical canal to reform adhesions under second-look hysteroscopy. C: No adhesions is observed in cervical canal after the stent removal.
Figure 5
Figure 5. Hysteroscopic images of unilateral uterine horn
A: Right uterine horn adhesions before hysteroscopic adhesiolysis; B: Two edges of the stent approximately reached the uterine horns to prevent adhesions reformation; C: A right uterine horn without adhesions after the stent removal.
See this image and copyright information in PMC

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