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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2025-01-01
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| Online Access: | https://doi.org/10.1371/journal.pone.0315709 |
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| author | Celine Bafort Sharon Lie Fong Steffen Fieuws Brecht Geysenbergh Michelle Nisolle Jean-Luc Squifflet Linda Tebache Christine Wyns Christel Meuleman Carla Tomassetti |
| author_facet | Celine Bafort Sharon Lie Fong Steffen Fieuws Brecht Geysenbergh Michelle Nisolle Jean-Luc Squifflet Linda Tebache Christine Wyns Christel Meuleman Carla Tomassetti |
| author_sort | Celine Bafort |
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| description | <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. |
| format | Article |
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| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Public Library of Science (PLoS) |
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| series | PLoS ONE |
| spelling | doaj-art-0d378564e6c44e898a42ed3e485ccd3f2025-08-20T02:00:51ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01203e031570910.1371/journal.pone.0315709Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial.Celine BafortSharon Lie FongSteffen FieuwsBrecht GeysenberghMichelle NisolleJean-Luc SquiffletLinda TebacheChristine WynsChristel MeulemanCarla Tomassetti<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.https://doi.org/10.1371/journal.pone.0315709 |
| spellingShingle | Celine Bafort Sharon Lie Fong Steffen Fieuws Brecht Geysenbergh Michelle Nisolle Jean-Luc Squifflet Linda Tebache Christine Wyns Christel Meuleman Carla Tomassetti Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. PLoS ONE |
| title | Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. |
| title_full | Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. |
| title_fullStr | Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. |
| title_full_unstemmed | Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. |
| title_short | Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. |
| title_sort | conservative endometrioma surgery the combined technique versus co2 laser vaporization only blast belgium laser study clinical protocol for a multicenter randomized controlled trial |
| url | https://doi.org/10.1371/journal.pone.0315709 |
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