An interventional study of ethanol sclerotherapy and stripping technique in Endometrioma, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment
The aim of this study is to compare two different laparoscopic surgical techniques (endometrioma stripping vs ethanol sclerotherapy) in terms of ovarian reserve (AMH levels), recurrence rate and pain relief.
Patients with pelvic pain (VAS score≥4) and ultrasound diagnosis of endometrioma > 4cm candidate to surgical removal of endometrioma will be randomized into 2 group. One Group will undergo laparoscopical stripping technique; the other one will undergo laparoscopic aspiration and sclerotherapy using 95% ethanol.
The women will be introduced with both operative options and they will be informed about the randomization . After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity \& parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), symptoms related to endometriosis (through VAS score), fertility history including any fertility treatment in the past and planned pregnancy after the operation.
The laparoscopy will take place in Fondazione Policlinico Gemelli IRCSS, Roma. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a Nelathon catheter. Ethanol will be left in the cyst for 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy.
The women will be followed at 1 , 3 , 6 and 12 months after the surgery.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 64 is close to the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
Procedure: ethanol sclerotherapy
cystectomy of endometriomas during laparoscopy
Procedure: stripping technique
Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol
Endometrioma laparoscopic cystectomy
impact on ovarian reserve, in terms of reduction of serum AMH levels
The AMH levels will be evaluated 1 month before the surgery and 1, 6 and 12 months after surgery.
Time frame: up to 12 months after the laparoscopy
endometrioma recurrence rate for the two surgical techniques
Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the procedure took place.
Time frame: up to 12 months after the laparoscopy
pain relief after surgery
The severity of pelvic pain , assessed using a visual analogue scale with no-pain classified as 0 and worst imaginable pain as 10.
Time frame: up to 12 months after the laparoscopy
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Catholic University of the Sacred Heart