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4DryField PH用于子宫内膜异位症切除及粘连预防后的生育力和疼痛改善:一项随机对照临床试验的随访

Improvement in Fertility and Pain after Endometriosis Resection and Adhesion Prevention with 4DryField PH: Follow-up of a Randomized Controlled Clinical Trial.

作者信息

Krämer Bernhard, Andress Jürgen, Neis Felix, Hoffmann Sascha, Brucker Sara, Kommoss Stefan, Höller Alice

机构信息

Department for Women's Health, University Hospital Tübingen, Calwerstr. 7, 72076 Tübingen, Germany.

出版信息

J Clin Med. 2023 May 22;12(10):3597. doi: 10.3390/jcm12103597.

DOI:10.3390/jcm12103597
PMID:37240703
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10218949/
Abstract

BACKGROUND

Adhesions after endometriosis resection are frequent and the most common causes for chronic pain and secondary infertility. Primary results of our randomized controlled trial (RCT) on adhesion prevention after deep infiltrating endometriosis (DIE) resection using the gel barrier 4DryField PH showed 85% adhesion reduction in second-look surgeries. Secondary endpoint data on fertility and pain development were collected during 12-month follow-ups.

METHODS

This RCT comprised 50 patients. Preoperatively and after 1, 6 and 12 months, pain scores for cycle-independent pelvic pain, dysmenorrhea, dyspareunia, dyschezia, and dysuria, as well as the number of pregnancies, were recorded,.

RESULTS

The pregnancy rate in the intervention group was significantly higher ( < 0.05). Pain development was also improved: after 12 months, all 5 subscores were lower in the intervention group and improvements were more pronounced, most prominently concerning cycle-independent pelvic pain and dysmenorrhea, the two subcategories with the highest preoperative scores and, therefore, the highest relevance for the patients. Cycle-independent pelvic pain even recurred in the control group, while barrier application prevented this.

CONCLUSIONS

Considering the known causal link between adhesions and pain, it is apparent that the favourable outcomes in the intervention group are linked to effective adhesion prevention. The significant increase in pregnancies is remarkable.

摘要

背景

子宫内膜异位症切除术后粘连很常见,是慢性疼痛和继发性不孕的最常见原因。我们使用凝胶屏障4DryField PH对深部浸润性子宫内膜异位症(DIE)切除术后粘连预防进行的随机对照试验(RCT)的初步结果显示,二次探查手术中粘连减少了85%。在12个月的随访期间收集了关于生育能力和疼痛发展的次要终点数据。

方法

这项RCT包括50名患者。在术前以及术后1、6和12个月,记录与月经周期无关的盆腔疼痛、痛经、性交痛、排便困难和排尿困难的疼痛评分以及妊娠次数。

结果

干预组的妊娠率显著更高(<0.05)。疼痛发展也有所改善:12个月后,干预组的所有5个分项评分均较低,且改善更为明显,最显著的是与月经周期无关的盆腔疼痛和痛经,这两个分项在术前评分最高,因此对患者最为重要。与月经周期无关的盆腔疼痛甚至在对照组中复发,而应用屏障可预防这种情况。

结论

考虑到粘连与疼痛之间已知的因果关系,很明显干预组的良好结果与有效的粘连预防有关。妊娠率的显著提高值得注意。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/0144b3702bee/jcm-12-03597-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/e2dc6c955f85/jcm-12-03597-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/d4ae4e440f8f/jcm-12-03597-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/2e69d21bb897/jcm-12-03597-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/0144b3702bee/jcm-12-03597-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/e2dc6c955f85/jcm-12-03597-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/d4ae4e440f8f/jcm-12-03597-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/2e69d21bb897/jcm-12-03597-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/902c/10218949/0144b3702bee/jcm-12-03597-g004.jpg

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