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一项新的腹腔镜卵巢子宫内膜异位症治疗技术预防复发和保护卵巢储备功能的随机对照试验。

A randomized controlled trial of a new technique for laparoscopic management of ovarian endometriosis preventing recurrence and keeping ovarian reserve.

机构信息

Obstetrics and Gynecology Department, Cairo University, 481 King Faisal Street Haram, Giza, 12111, Egypt.

出版信息

J Ovarian Res. 2019 Jul 20;12(1):66. doi: 10.1186/s13048-019-0542-0.

Abstract

INTRODUCTION

Laparoscopic cystectomy provides more favourable outcomes as regards the recurrence and subsequent clinical pregnancy rates. It is associated with significant reduction in the ovarian reserve due to the inevitable removal of unaffected ovarian tissue. The aim of our study was to evaluate the efficiency of Surgicel in preventing recurrence of endometriomas after their laparoscopic conservative management (cystectomy or drainage).

MATERIAL AND METHODS

A randomized controlled trial included two hundred women (candidate for conservative laparoscopic management of ovarian endometriomas). They were randomized into four groups; group D in which patients underwent laparoscopic drainage of the endometrioma, group C in which patients underwent laparoscopic cystectomy of the endometrioma, group DS in which patients underwent laparoscopic drainage followed by insertion of Surgicel inside the cyst cavity & group CS in which patients underwent laparoscopic cystectomy of the endometrioma followed by insertion of Surgicel inside the remaining ovarian tissues. All patients were followed up for 2 years & the primary outcome was the recurrence of endometriomas in the ipsilateral ovary & the postoperative ovarian reserve was reassessed as a secondary outcome.

RESULTS

The Surgicel-treated groups had significantly lower hazard of recurrence compared to untreated groups (p = 0.004). Group CS had significantly lower hazard of recurrence compared to Group D & C (p = 0.014, 0.046 respectively). Group DS had significantly lower hazard of recurrence compared to Group D (p = 0.039) but it not significantly different from Group C (p = 0.112). Group DS had the lowest drop of AMH and was significantly lower than the other three groups.

CONCLUSION

Surgicel reduces effectively the recurrence risk of endometriomas and its use during laparoscopic drainage is an effective alternative for traditional laparoscopic cystectomy with minimal affection of the patient ovarian reserve.

TRIAL REGISTRATION

Name of the registry: clinicaltrials.gov. Trial registration number NCT02947724 . Date of registration October 28, 2016.

摘要

简介

腹腔镜囊肿切除术在复发和后续临床妊娠率方面提供了更好的结果。由于不可避免地切除了未受影响的卵巢组织,因此它与卵巢储备功能的显著降低有关。我们研究的目的是评估 Surgicel 在预防腹腔镜保守治疗(囊肿切除术或引流术)后子宫内膜异位瘤复发方面的效率。

材料和方法

一项随机对照试验纳入了 200 名女性(候选行卵巢子宫内膜异位瘤腹腔镜保守管理的患者)。她们被随机分为四组;D 组患者行腹腔镜内子宫内膜异位瘤引流术,C 组患者行腹腔镜内子宫内膜异位瘤囊肿切除术,DS 组患者行腹腔镜内子宫内膜异位瘤引流术,然后将 Surgicel 插入囊肿腔内,CS 组患者行腹腔镜内子宫内膜异位瘤囊肿切除术,然后将 Surgicel 插入剩余卵巢组织内。所有患者均随访 2 年,主要结局为同侧卵巢内子宫内膜异位瘤的复发,次要结局为术后卵巢储备功能的重新评估。

结果

Surgicel 治疗组的复发风险明显低于未治疗组(p=0.004)。CS 组的复发风险明显低于 D 组和 C 组(p=0.014、0.046)。DS 组的复发风险明显低于 D 组(p=0.039),但与 C 组无显著差异(p=0.112)。DS 组的 AMH 下降幅度最低,明显低于其他三组。

结论

Surgicel 可有效降低子宫内膜异位瘤的复发风险,在腹腔镜引流术中使用 Surgicel 是传统腹腔镜囊肿切除术的有效替代方法,对患者的卵巢储备功能影响最小。

试验注册

注册名称:clinicaltrials.gov。试验注册号 NCT02947724。注册日期 2016 年 10 月 28 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41f7/6642736/c6a5f9f1b42f/13048_2019_542_Fig1_HTML.jpg

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