Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a multicenter, randomized, controlled trial

Robotic and laparoscopic surgery for endometriosis had comparable operative length, blood loss, complication rates, and quality of life improvements after surgical intervention.

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Volume 107, Issue 4, Pages 996–1002.e3

Authors:

Enrique Soto, M.D., M.Sc., Thanh Ha Luu, M.D., Xiaobo Liu, M.S., Javier F. Magrina, M.D., Megan N. Wasson, D.O., Jon I. Einarsson, M.D., Sarah L. Cohen, M.D., M.P.H., Tommaso Falcone, M.D.

Abstract:

NCT01556204.


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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Go to the profile of Michelle Nisolle
Michelle Nisolle about 3 years ago

The laparoscopic management of deep infiltrating endometriosis (DIE) can, under certain circumstances, constitute a real challenge. It has recently been suggested that robotic-assisted laparoscopy (RAL) could improve the peri- and post-operative outcomes.

Berlanda et al reviewed the role of RAL in the treatment of endometriosis and concluded that controlled studies demonstrating its benefits over standard laparoscopy (LP) were lacking (1).

The first randomized clinical trial comparing laparoscopy versus robotic surgery for endometriosis has been published in April 2017 by Soto et al(2).  In this manuscript, the authors randomized pre-operatively 35 women in the RAL group and 38 women in the LP group. As mentioned in the inclusion criteria section, women with pain or infertility with presumed endometriosis were selected to participate in the study.  Unfortunately, in both groups, patients were found to be without macroscopic endometriosis: 6 in the RAL group and 15 in the LP group.

It means that conclusions of this multicentric random RCT on LP versus RAL for endometriosis treatment were given by analyzing the results of a series of 78 women among whom 29 % of them were not suffering from endometriosis. Only patients with stage I/II and stage III / IV endometriosis should have been evaluated even if histology did not confirm the peri-operative diagnosis. Indeed the rate of histological confirmation of endometriosis is estimated to be about 45-50 % (3). Patients with no visible endometriosis should have been excluded.

In a such important RCT the pre-operative diagnosis of endometriosis should have been carried out by a thorough clinical examination and/or imaging techniques such as Transvaginal Ultrasonography (TVS) or Magnetic Resonance Imaging (MRI) as the sensitivity and specificity are respectively 90 % and 96 % for TVS and 92 % and 96% for MRI in search for rectosigmoid endometriosis(4).
Even if the authors concluded that there were no differences in peri-operative outcomes, we must be aware that only 52 patients were operated for endometriosis and the analysis of this subgroup is not detailed in this manuscript.

Therefore, the conclusion of this first multicenter RCT is questionable.


M. NISOLLE, MD, PhD (michelle.nisolle@chu.ulg.ac.be)

G. BRICHANT, MD

 

1.            Berlanda N, Frattaruolo MP, Aimi G, Farella M, Barbara G, Buggio L et al. 'Money for nothing'. The role of robotic-assisted laparoscopy for the treatment of endometriosis. Reprod Biomed Online 2017;35:435-44.

2.            Soto E, Luu TH, Liu X, Magrina JF, Wasson MN, Einarsson JI et al. Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a multicenter, randomized, controlled trial. Fertil Steril 2017;107:996-1002 e3.

3.            Balasch J, Creus M, Fabregues F, Carmona F, Ordi J, Martinez-Roman S et al. Visible and non-visible endometriosis at laparoscopy in fertile and infertile women and in patients with chronic pelvic pain: a prospective study. Hum Reprod 1996;11:387-91.

4.            Nisenblat V, Prentice L, Bossuyt PM, Farquhar C, Hull ML, Johnson N. Combination of the non-invasive tests for the diagnosis of endometriosis. Cochrane Database Syst Rev 2016;7:Cd012281.