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| Name | Class |
|---|---|
| University Hospital Ostrava | OTHER |
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The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate
Only patients who sign informed consent will be included. Only patients wishing for future pregnancy will be involved in the study. Expected number of enrolled subjects is 160 ( 80 in each arm) Patients with endometrioma and planned surgery to remove it will be randomized either to laparoscopic sclerotherapy with 96% ethanol or cystectomy. First AMH sample will be taken day before surgery. If other endometriosis lesions (deep or superficial) are present, they may be also resected during this surgery.
Ethanol sclerotherapy description: classical laparoscopic approach - small (max1cm) fenestration of endometrioma - aspiration of endometrioma contents- foley catheter insertion- ballon inflation inside of the cyst- instillation with 96% ethanol which is left in the cyst for 10min- aspiration of ethanol and flushing with saline.
Cystectomy: classical laparoscopic approach- large fenestration of endometrioma - aspiration of endometrioma contents- indentification of ovary/ endometrioma tissue and plane between the ovarian capsule and cyst wall is developed using a mix of blunt and sharp dissection - if bleeding is present it is stopped by cautious bipolar coagulation
visit 1 - surgery time (AMH day before surgery, age, BMI, endometriosis extent, gravidity/ parity, endometriosis residue after surgery, pain levels) visit 2- 3 months after surgery : Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 3+4 - 6/12months after surgery: AMH, Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 5- 24 months after surgery: Ultrasound, complications, pregnancy, asissted reproduction, pain levels
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic ethanol sclerotherapy | Active Comparator |
| |
| laparoscopic cystectomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic ethanol sclerotherapy | Procedure | ethanol (96%) sclerapy of endometrioma - endometrioma is filled with ethanol via foley catether, left for 10 min and than aspirated, endometrioma is washed with saline |
| Measure | Description | Time Frame |
|---|---|---|
| AMH dynamics | Measuring AMH level in blood | Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery |
| endometrioma recurrence | recurrence described as endometrioma measuring 20 or more milimeters on ultrasound | Measuring change of endometrioma size (in case of recurrence) at 3, 6, 12 and 24 months after surgery |
| complications | recording all complications related to surgery, classified according Clavien Dindo | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asissted reproduction methods succes rate | if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used | 0-24 months after surgery |
| pregnancy rate | pregnancy rate among study patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarína Ivánková | Contact | +420 296511200 | katarina.ivankova@upmd.eu |
| Name | Affiliation | Role |
|---|---|---|
| Katarína Ivánková, MUDr. | Institute for the Care of Mother and Child, Prague, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for mother and child care | Recruiting | Prague | 147 00 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29420391 | Background | Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469. | |
| 12858105 | Background | Busacca M, Vignali M. Ovarian endometriosis: from pathogenesis to surgical treatment. Curr Opin Obstet Gynecol. 2003 Aug;15(4):321-6. doi: 10.1097/01.gco.0000084247.09900.4f. |
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| laparoscopic cystectomy of endometrioma | Procedure | cystectomy of endometrioma - removal of endometrioma from ovary surgically |
|
| 0-24 months after surgery |
| deliveries | number of deliveries after surgery | 24 months |
| 28579409 | Background | Cohen A, Almog B, Tulandi T. Sclerotherapy in the management of ovarian endometrioma: systematic review and meta-analysis. Fertil Steril. 2017 Jul;108(1):117-124.e5. doi: 10.1016/j.fertnstert.2017.05.015. Epub 2017 Jun 1. |
| 29935810 | Background | Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20. |
| 36228863 | Background | Crestani A, Merlot B, Dennis T, Chanavaz-Lacheray I, Roman H. Impact of Laparoscopic Sclerotherapy for Ovarian Endometriomas on Ovarian Reserve. J Minim Invasive Gynecol. 2023 Jan;30(1):32-38. doi: 10.1016/j.jmig.2022.10.001. Epub 2022 Oct 10. |
| 32380241 | Background | De Cicco Nardone A, Carfagna P, De Cicco Nardone C, Scambia G, Marana R, De Cicco Nardone F. Laparoscopic Ethanol Sclerotherapy for Ovarian Endometriomas: Preliminary Results. J Minim Invasive Gynecol. 2020 Sep-Oct;27(6):1331-1336. doi: 10.1016/j.jmig.2019.09.792. Epub 2020 May 5. |
| 19502358 | Background | Benaglia L, Somigliana E, Vercellini P, Abbiati A, Ragni G, Fedele L. Endometriotic ovarian cysts negatively affect the rate of spontaneous ovulation. Hum Reprod. 2009 Sep;24(9):2183-6. doi: 10.1093/humrep/dep202. Epub 2009 Jun 5. |
| 20083485 | Background | Benaglia L, Somigliana E, Vighi V, Ragni G, Vercellini P, Fedele L. Rate of severe ovarian damage following surgery for endometriomas. Hum Reprod. 2010 Mar;25(3):678-82. doi: 10.1093/humrep/dep464. Epub 2010 Jan 17. |
| 35698769 | Background | Jee BC. Efficacy of ablation and sclerotherapy for the management of ovarian endometrioma: A narrative review. Clin Exp Reprod Med. 2022 Jun;49(2):76-86. doi: 10.5653/cerm.2021.05183. Epub 2022 May 4. |
| 26492167 | Background | Giampaolino P, Bifulco G, Di Spiezio Sardo A, Mercorio A, Bruzzese D, Di Carlo C. Endometrioma size is a relevant factor in selection of the most appropriate surgical technique: a prospective randomized preliminary study. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:88-93. doi: 10.1016/j.ejogrb.2015.09.046. Epub 2015 Oct 24. |
| 32272240 | Background | Garcia-Tejedor A, Martinez-Garcia JM, Candas B, Suarez E, Manalich L, Gomez M, Merino E, Castellarnau M, Regueiro P, Carreras M, Martinez-Franco E, Carrarrach M, Subirats N, Barbera J, Gonzalez S, Climent M, Fernandez-Montoli E, Ponce J. Ethanol Sclerotherapy versus Laparoscopic Surgery for Endometrioma Treatment: A Prospective, Multicenter, Cohort Pilot Study. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1133-1140. doi: 10.1016/j.jmig.2019.08.036. Epub 2020 Apr 7. |
| 33349801 | Background | Aflatoonian A, Tabibnejad N. Aspiration versus retention ultrasound-guided ethanol sclerotherapy for treating endometrioma: A retrospective cross-sectional study. Int J Reprod Biomed. 2020 Nov 22;18(11):935-942. doi: 10.18502/ijrm.v13i11.7960. eCollection 2020 Nov. |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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