Endometrioma, Endometriosis
Conditions
Keywords
laparoscopic, sclerotherapy, endometrioma
Brief summary
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
Detailed description
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
Interventions
PROCEDURElaparoscopic ethanol sclerotherapy
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
PROCEDURElaparoscopic cystectomy of endometrioma
cystectomy of endometrioma - removal of endometrioma from ovary surgically
Sponsors
University Hospital Ostrava
Institute for the Care of Mother and Child, Prague, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* IOTA benign endometrioma * bilateral or unilateral endometrioma measuring 30 or more milimeters * patients with unfinished reproductive plans
Exclusion criteria
* bilateral recurrence of endometrioma * recurrent endometrioma if the other ovary is not present or patient had cystectomy on the other ovary * suspision for ovarian malignancy * signs of inflammatory pelvic disease * disagreement with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AMH dynamics | Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery | Measuring AMH level in blood |
| endometrioma recurrence | Measuring change of endometrioma size (in case of recurrence) at 3, 6, 12 and 24 months after surgery | recurrence described as endometrioma measuring 20 or more milimeters on ultrasound |
| complications | 0-12 months | recording all complications related to surgery, classified according Clavien Dindo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asissted reproduction methods succes rate | 0-24 months after surgery | if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used |
| pregnancy rate | 0-24 months after surgery | pregnancy rate among study patients |
| deliveries | 24 months | number of deliveries after surgery |
Countries
Czechia
Contacts
Primary ContactKatarína Ivánková
Outcome results
None listed