Endometrial resection / ablation techniques for heavy menstrual bleeding

 

Abstract

Background

Heavy menstrual bleeding (HMB) is a significant health problem in premenopausal women; it can reduce their quality of life and cause anaemia. First-line therapy has traditionally been medical therapy but this is frequently ineffective. On the other hand, hysterectomy is obviously 100% effective in stopping bleeding but is more costly and can cause severe complications. Endometrial ablation is less invasive and preserves the uterus, although long-term studies have found that the costs of ablative surgery approach the cost of hysterectomy due to the requirement for repeat procedures. A large number of techniques have been developed to 'ablate' (remove) the lining of the endometrium. The gold standard techniques (laser, transcervical resection of the endometrium and rollerball) require visualisation of the uterus with a hysteroscope and, although safe, require skilled surgeons. A number of newer techniques have recently been developed, most of which are less time consuming. However, hysteroscopy may still be required as part of the ablative techniques and some of them must be considered to be still under development, requiring refinement and investigation.

Objectives

To compare the efficacy, safety and acceptability of methods used to destroy the endometrium to reduce HMB in premenopausal women.

Search methods

We searched MEDLINE, EMBASE, CINAHL, PsycInfo, the Cochrane Central Register of Controlled Trials and the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of controlled trials (from inception to August 2009). We also searched trial registers and other sources of unpublished or grey literature, reference lists of retrieved studies, experts in the field and made contact with pharmaceutical companies that manufactured ablation devices.

Selection criteria

Randomised controlled trials comparing different endometrial ablation techniques in women with a complaint of heavy menstrual bleeding without uterine pathology. The outcomes included reduction of heavy menstrual bleeding, improvement in quality of life, operative outcomes, satisfaction with the outcome, complications and need for further surgery or hysterectomy.

Data collection and analysis

The two review authors independently selected trials for inclusion, assessed trials for quality and extracted data. Attempts were made to contact authors for clarification of data in some trials. Adverse events were only assessed if they were separately measured in the included trials.

Main results

In the comparison of the newer 'blind' techniques (second generation) with the gold standard hysteroscopic ablative techniques (first generation), there was no evidence of overall differences in the improvement in HMB or patient satisfaction.

Surgery was an average of 15 minutes shorter (weighted mean difference (WMD) 14.9, 95% CI 10.1 to 19.7), local anaesthesia was more likely to be employed (odds ratio (OR) 6.4, 95% CI 3.0 to 13.7) and equipment failure was more likely (OR 4.6, 95% CI 1.5 to 14.0) with second-generation ablation. Women undergoing newer ablative procedures were less likely to have fluid overload, uterine perforation, cervical lacerations and hematometra than women undergoing the more traditional type of ablation and resection techniques (OR 0.17, 95% CI 0.04 to 0.77; OR 0.32, 95% CI 0.1 to 1.0; OR 0.22, 95% CI 0.08 to 0.6 and OR 0.31, 95% CI 0.11 to 0.85, respectively). However, women were more likely to have nausea and vomiting and uterine cramping (OR 2.4, 95% CI 1.6 to 3.9 and OR 1.8, 95% CI 1.1 to 2.8, respectively).

Authors' conclusions

Endometrial ablation techniques offer a less invasive surgical alternative to hysterectomy. The rapid development of a number of new methods of endometrial destruction has made systematic comparisons between methods and with the 'gold standard' first generation techniques difficult. Most of the newer techniques are technically easier than hysteroscopy-based methods to perform but technical difficulties with new equipment need to be ironed out. Overall, the existing evidence suggests that success rates and complication profiles of newer techniques of ablation compare favourably with hysteroscopic techniques.

 

Plain language summary

Endometrial destruction techniques for heavy menstrual bleeding using the newer global ablation techniques and more established hysteroscopic techniques

Drugs or hysterectomy (removing the uterus) used to be the main option for women having problems with heavy menstrual bleeding (menorrhagia). In the last few decades, surgical techniques have been developed that remove only the lining of the uterus (endometrium). These techniques involve either cutting out the endometrium (resection) or destroying it with thermal energy from a laser, electric instruments or other devices. This review has not found that any of these procedures is better than any other in reducing heavy menstrual bleeding and satisfaction was high with all procedures. The more modern devices (second generation ablation) took less time to perform than the older first generation devices and were more likely to be performed under local anaesthesia when the woman is awake. Side effects were generally similar and mostly mild.

 

摘要

背景

對於月經時大量出血所用的子宮內膜切除/燒灼術

對於停經前的婦女們而言，月經時大量出血(HMB)是一種顯著的健康問題；它可能會降低這些婦女們的生活品質，並且引發貧血。傳統上，第一線的治療方法都是藥物，但是這樣的方法通常都沒有什麼功效。另一方面，子宮切除術對於中止出血來說，很顯然地具有100% 的效果，但是它的花費比較高，而且有可能會引起嚴重的併發症。子宮內膜燒灼術屬於比較不具有侵入性的方式，並且可以保存子宮，但是長期的研究發現，燒灼手術的那些費用總合會接近於子宮切除術的費用，因為它需要重複進行那些流程。有很多的技術已經被人們開發出來，可以用來「燒灼」(清除)子宮內膜的裡層。黃金標準技術(雷射、經子宮頸的內膜切除術，以及電燒球)都必需使用用子宮鏡來看到子宮，而且即便這些技術都很安全，還是需要有技術純熟的外科醫生。最近又有很多更新的技術被開發出來，其中大多數的技術都可以在更短的時間內完成操作。然而，這些燒灼的技術仍然需要使用到子宮鏡，有些仍在發展中，需要進一步探討及精進。

目標

比較破壞子宮內膜以減少停經前婦女大量經血的各種方法的效果，安全性及可接受度。

搜尋策略

我們搜尋MEDLINE、EMBASE、CINAHL、PsycInfo、Cochrane Central Register of Controlled Trials以及Cochrane Menstrual Disorders 以及Subfertility Group Specialised Register of controlled trials (開始自2009年8月) 。我們也搜尋了試驗登錄中心以及其他未發表或灰色文獻來源、所搜尋到文章的參考文獻清單、本領域的專家，並且與製造燒灼器具的藥廠聯繫。

選擇標準

針對月經時大量出血、而又沒有明顯子宮痛灶婦女的隨機對照試驗比較了不同的子宮內膜燒灼技術。結果包括了減少月經時大量的出血量、改善生活的品質、手術的結果對於結果的滿意程度、併發症，以及是否需要進一步的手術或是子宮切除術。

資料收集與分析

兩位文獻回顧的作者獨自選擇納入的試驗、評估試驗的品質，並且擷取出資料。嘗試與作者們聯繫以釐清一些試驗的資料。納入的試驗有獨立報告不良事件的，才會列入不良事件的評估。

主要結論

在比較新的「盲法」技術(第2代)當中，跟黃金標準型的子宮鏡燒灼術(第1代)比較起來，在改善月經時的大量出血或是病患的滿意度方面，整體上沒有差異。在第二代燒灼術中，手術的平均時間可以縮短15分鐘(加權平均差(WMD) 14.9，95% CI 10.1 到19.7)，較易以局部麻醉進行，但設備故障的情況卻顯得比較多(OR 4.6，95% CI 1.5到14.0)。跟接受了傳統類型之燒灼與切除技術的婦女們比較起來，接受了較新式燒灼技術過程的婦女們，就比較少發生體液過多、子宮穿孔、子宮頸裂傷，以及子宮腔積血等情形(分別為OR 0.17，95% CI 0.04到0.77；OR 0.32，95% CI 0.1 到1.0；OR 0.22，95% CI 0.08到0.6以及OR 0.31，95% CI 0.11到0.85)。然而，這些婦女們卻比較容易發生噁心與嘔吐，以及子宮抽筋等情形(分別為OR 2.4，95% CI 1.6 到 3.9以及OR 1.8，95% CI 1.1到2.8)。

作者結論

跟子宮切除術比較起來，子宮內膜燒灼的技術提供了一種較不具有侵入性的手術選擇。由於破壞子宮內膜方法的快速發展，使得我們想要在這些方法與「黃金標準」的第一代技術之間進行系統性的比較時，就變得非常困難。跟以子宮鏡為基礎的方法比較起來，對於大多數的較新式技術而言，在操作方面所需要的技術都變得比較簡單了，但是新設備在技術方面所帶來的難題，則還有許多歧見必須要消除。整體而言，現有的證據都顯示，跟子宮鏡式的各項技術比較起來，較新式的燒灼技術在成功比率與併發症的情況方面，都占有比較大的優勢。

翻譯人

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

使用各種較新式的整體燒灼技術以及更成熟的子宮鏡式技術，都是針對月經時大量出血所用的子宮內膜去除技術。對於面臨著月經時大量出血(經血過多)之困擾的婦女們而言，藥物或是子宮切除術(去除掉子宮)常是主要的選擇治療方式。在過去的數10年當中，只移除子宮裡層(子宮內膜)的手術技術以被開發出來。這些技術包括了切除子宮內膜(切除術)，或是使用某種雷射、電子儀器，或是其他裝置的熱能來破壞它。就減少月經時大量的出血量而言，本篇回顧並沒有發現有任一手術方法優於其他，但所有的手術方法滿意度都很高。跟之前的第一代設備比較起來，較為近期的設備(第2代燒灼)所需要的操作時間比較少，而且比較可能在婦女清醒的情況下，在局部麻醉下進行。所有的副作用通常都很類似，而且大部分都是輕微的。