surgical management of endometriosis: excision or ablation

1
Editorial Surgical Management of Endometriosis: Excision or Ablation DISCUSS You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-22-2-JMIG-D-14-00000 Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace. There are many ‘‘great debates’’ on the surgical manage- ment of endometriosis. The management of ovarian, bowel, and peritoneal endometriosis seems to be at the forefront of this contention. Specifically for the latter is whether to excise or ablate the lesion. When there is deep involvement of adja- cent organs, there is general consensus that excision is best for optimal surgical outcome. However, for disease involving the peritoneum alone, there are proponents for either option. In this issue, Healy et al [1] report on a 5- year follow-up of their initial randomized clinical trial pub- lished in 2010 [2]. In the initial study, follow-up questionnaires documented pain levels every 3 months for 1 year. In this report, the same questionnaires documented pain every 6 months until 5 years. The study showed that excision of endometriosis provides an advantage over ablation when treating dyspareu- nia. A further observation in this study was that ablation had 1.64 times more patients requiring further medical treatment of endometriosis. At first glance, this study supports the use of excision over ablation. It is important to note that there was a reduction in all pain scores over the 5-year follow- up in both treatment groups. There are some limitations to this study. Although the design is adequate, the study had a very high nonresponse rate at year 5. A total of 88 of the 178 questionnaires were not returned. In the end, there were 42 observations in the ablation group and 40 in the excision group. Although the randomized double-blind controlled trial was believed to be the first of its kind to have a sample size as large as 178 and believed to have sufficient prior power, our concerns are with the posterior power, the sample sizes at the end point. Although the results did not show any significant dif- ference in the reduction of pain score between the 2 groups 1 year after surgery, the reduction in sample over time is a point of concern. Also, the continued trend toward a larger reduction with dyspareunia and pain on defecation in the excision group at 1 year may be affected based on the char- acteristics of the high dropouts after a year. It should also be noted that the initial groups were different despite randomi- zation. Specifically, there were more patients with deeply infiltrating endometriosis in the excision group than the abla- tion group (53% in the excision group and 22% in the abla- tion) group. The study addresses secondary hypotheses for which the study was not designed; sample size and power were also not addressed. The study, with its varying sample sizes, used tests for proportions that perform best under large sample sizes. Also, the study used several tests that examined 2 vari- ables at a time rather than relying on a simultaneous effect of multivariable. It is important to note that both approaches to analyzing the data are not answering the same question. The problem is that one is usually more interested in the multi- variable approach because it better mimics the relationships of covariates in life. In summary, surgical therapy is effective at treating endometriosis-associated pain. Although there are limita- tions in study design, this randomized double-blind clinical trial observed that excision is more effective than ablation when treating dyspareunia. Tommaso Falcone, MD Cleveland, OH Jeffrey R. Wilson, PhD Tempe, AZ References 1. Healy M, Cheng C, Kaur H. To excise or ablate endometriosis? A pro- spective randomized double blind trial after 5 years follow-up. J Minim Invasive Gynecol. 2014;21(6):999–1004. 2. Healy M, Ang WC, Cheng C. Surgical treatment of endometriosis: a pro- spective randomized double blind trial comparing excision and ablation. Fertil Steril. 2010;94:2536–2540. 1553-4650/$ - see front matter Ó 2014 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2014.09.001

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Page 1: Surgical Management of Endometriosis: Excision or Ablation

Editorial

Surgical Management of Endometriosis: Excision or Ablation

DISCUSS

1553-4650/$ - se

http://dx.doi.org/1

You can discuss this article with its authors and with other AAGL members athttp://www.AAGL.org/jmig-22-2-JMIG-D-14-00000

e front matter � 2014 AAGL. All rights reserved.

0.1016/j.jmig.2014.09.001

Utoadth

se your Smartphonescan this QR code

nd connect to theiscussion forum foris article now*

* Download a free QR Code scanner by searching for ‘‘QRscanner’’ in your smartphone’s app store or app marketplace.

There are many ‘‘great debates’’ on the surgical manage-ment of endometriosis. The management of ovarian, bowel,and peritoneal endometriosis seems to be at the forefront ofthis contention. Specifically for the latter is whether to exciseor ablate the lesion. When there is deep involvement of adja-cent organs, there is general consensus that excision is bestfor optimal surgical outcome. However, for diseaseinvolving the peritoneum alone, there are proponents foreither option. In this issue, Healy et al [1] report on a 5-year follow-up of their initial randomized clinical trial pub-lished in 2010 [2].

In the initial study, follow-up questionnaires documentedpain levels every 3 months for 1 year. In this report, the samequestionnaires documented pain every 6 months until5 years. The study showed that excision of endometriosisprovides an advantage over ablation when treating dyspareu-nia. A further observation in this study was that ablation had1.64 times more patients requiring further medical treatmentof endometriosis. At first glance, this study supports the useof excision over ablation. It is important to note that therewas a reduction in all pain scores over the 5-year follow-up in both treatment groups.

There are some limitations to this study. Although thedesign is adequate, the study had a very high nonresponserate at year 5. A total of 88 of the 178 questionnaires werenot returned. In the end, there were 42 observations in theablation group and 40 in the excision group. Although therandomized double-blind controlled trial was believed tobe the first of its kind to have a sample size as large as 178and believed to have sufficient prior power, our concernsare with the posterior power, the sample sizes at the endpoint. Although the results did not show any significant dif-ference in the reduction of pain score between the 2 groups1 year after surgery, the reduction in sample over time is apoint of concern. Also, the continued trend toward a largerreduction with dyspareunia and pain on defecation in theexcision group at 1 year may be affected based on the char-

acteristics of the high dropouts after a year. It should also benoted that the initial groups were different despite randomi-zation. Specifically, there were more patients with deeplyinfiltrating endometriosis in the excision group than the abla-tion group (53% in the excision group and 22% in the abla-tion) group.

The study addresses secondary hypotheses for which thestudy was not designed; sample size and power were also notaddressed. The study, with its varying sample sizes, usedtests for proportions that perform best under large samplesizes. Also, the study used several tests that examined 2 vari-ables at a time rather than relying on a simultaneous effect ofmultivariable. It is important to note that both approaches toanalyzing the data are not answering the same question. Theproblem is that one is usually more interested in the multi-variable approach because it better mimics the relationshipsof covariates in life.

In summary, surgical therapy is effective at treatingendometriosis-associated pain. Although there are limita-tions in study design, this randomized double-blind clinicaltrial observed that excision is more effective than ablationwhen treating dyspareunia.

Tommaso Falcone, MDCleveland, OH

Jeffrey R. Wilson, PhDTempe, AZ

References

1. Healy M, Cheng C, Kaur H. To excise or ablate endometriosis? A pro-

spective randomized double blind trial after 5 years follow-up. J Minim

Invasive Gynecol. 2014;21(6):999–1004.

2. HealyM, AngWC, Cheng C. Surgical treatment of endometriosis: a pro-

spective randomized double blind trial comparing excision and ablation.

Fertil Steril. 2010;94:2536–2540.