Abstract

Background

Laparoscopic cystectomy is currently considered the gold standard for the treatment of ovarian endometrioma, resulting in an improvement in symptoms, a lower recurrence rate, and a higher pregnancy rate among infertile patients. However, this treatment is not free from risk, since it is associated with a reduction in ovarian reserve. There is still controversy in the literature regarding whether the cause of the reduction in ovarian reserve is due to damage caused by the coagulation energy during hemostasis or whether the procedure itself is the cause of the damage irrespective of the hemostatic method used. The aim of this study is to compare the effects of different hemostatic methods on the ovarian function of women subjected to laparoscopic surgery for ovarian endometrioma.

Methods

An open-label randomized clinical trial to be conducted at the Lauro Wanderley University Hospital between December 2017 and August 2020. Eighty-four patients will be randomly allocated to three groups according to the hemostatic technique used during laparoscopic surgery for ovarian endometrioma: bipolar coagulation; laparoscopic suture; and hemostatic matrix. Ovarian function will be assessed by serum anti-Müllerian hormone measurement and by performing an antral follicle count using ultrasound before surgery and one, three, and six months after surgery. The internal review board of the Medical Sciences Center, Federal University of Paraíba approved the study protocol under reference CAAE 71621717.9.0000.8069.

Discussion

Bearing in mind the need for more randomized clinical trials to clarify this issue, we hope to contribute with data that will determine whether there is any difference between hemostatic methods despite the rational use of bipolar energy or whether the procedure itself explains the ovarian damage irrespective of the hemostatic technique used.

Trial registration

ClinicalTrials.gov, NTC03430609. Registered on XX.10/31/2017.

ISRCTN Registry, ISRCTN11469394. Registered on XX.17/12/2017.

Unique Protocol ID: U1111–1203-2508.

Details

Title
Ovarian function after the use of various hemostatic techniques during treatment for endometrioma: protocol for a randomized clinical trial
Author
Araujo, Raquel Silveira da Cunha 1   VIAFID ORCID Logo  ; Maia, Sabina Bastos 2 ; Baracat, Clara Micalli Ferruzzi 3 ; Lima, Moisés Diogo 2 ; Soares, Eduardo Sérgio Sousa 2 ; Ribeiro, Helizabet Salomão Abdalla Ayroza 3 ; Ribeiro, Paulo Augusto Ayroza Galvão 3 

1  Federal University of Paraíba, Department of Obstetrics and Gynecology, Lauro Wanderley University Hospital, João Pessoa, Brazil (GRID:grid.411216.1) (ISNI:0000 0004 0397 5145); Santa Casa de São Paulo School of Medical Science, Gynecological Endoscopy and Endometriosis Division, Department of Obstetrics and Gynecology, São Paulo, Brazil (GRID:grid.419014.9) (ISNI:0000 0004 0576 9812) 
2  Federal University of Paraíba, Department of Obstetrics and Gynecology, Lauro Wanderley University Hospital, João Pessoa, Brazil (GRID:grid.411216.1) (ISNI:0000 0004 0397 5145) 
3  Santa Casa de São Paulo School of Medical Science, Gynecological Endoscopy and Endometriosis Division, Department of Obstetrics and Gynecology, São Paulo, Brazil (GRID:grid.419014.9) (ISNI:0000 0004 0576 9812) 
Pages
410
Publication year
2019
Publication date
Dec 2019
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-019-3524-z
ProQuest document ID
2795253525
Copyright
© The Author(s). 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.