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Open Access 01-12-2019 | Laparoscopy | Study protocol
Ovarian function after the use of various hemostatic techniques during treatment for endometrioma: protocol for a randomized clinical trial
Published in: Trials | Issue 1/2019
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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.