Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial.
<h4>Background</h4>The surgical management of endometrioma(s) remains challenging. Although laparoscopic surgery is a well-established treatment of endometrioma(s), caution is required to minimize ovarian damage. Several surgical techniques have been described to treat endometrioma(s): c...
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| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2025-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0315709 |
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| Summary: | <h4>Background</h4>The surgical management of endometrioma(s) remains challenging. Although laparoscopic surgery is a well-established treatment of endometrioma(s), caution is required to minimize ovarian damage. Several surgical techniques have been described to treat endometrioma(s): classical cystectomy, ablative techniques, or a combination of both. As cystectomy is strongly associated with a reduction in ovarian reserve, this randomized controlled trial (RCT) aims to determine to what extent the two other surgical procedures may affect ovarian reserve by comparing changes in serum anti-Müllerian hormone (AMH) levels concentrations after each type of surgery.<h4>Methods</h4>This is a multicenter, non-blinded, RCT with parallel groups (group 1 (combined technique) versus group 2 (CO2 laser vaporization only)) and allocation 1:1. Four Belgian centers will be involved. Main inclusion criteria are symptomatic patients (pain and/or infertility), 18-40 years (both inclusive) with an endometriotic cyst (mean diameter of ≥ 2.5 cm and ≤ 8 cm) and AMH level ≥ 0.7 ng/mL. Suspicion of malignancy, a contralateral endometrioma of > 2 cm, use of gonadotrophin-releasing hormone (GnRH) analogues around timing of surgery or previous oophorectomy are exclusion criteria. The primary aim is the evaluation of the difference in serum AMH levels between baseline and 3 months postoperatively (or delta AMH). The secondary outcomes include differences in AMH levels at 6 and 12 months postoperatively, cyst recurrence rate, evolution of pain pattern and fertility outcomes.<h4>Discussion</h4>The present study will help us to answer the question on which surgical technique for endometrioma(s) has the most favorable outcome in patients wishing to preserve their reproductive potential.<h4>Trial registration</h4>ClinicalTrials.gov: NCT04151433. Registered on November 5th, 2019. |
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| ISSN: | 1932-6203 |