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The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:
• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?
Participants will:
Catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. However, whether the sclerosing agent should be retained inside the endometrioma was controversial. To increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-session catheter-directed sclerotherapy | Experimental | Each patient received two sessions of catheter-directed sclerotherapy for endometrioma 1 day apart with the catheter left in situ overnight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-session catheter-directed sclerotherapy | Procedure | After receiving the first session of catheter-directed sclerotherapy, each patient carries the catheter overnight and is closely monitored in the patient ward. Then, the patient receives the second session the next day. The catheter is removed after the second session. The procedure was performed under intravenous sedoanalgesia using a combination of 25 mg pethidine hydrochloride and 50 mg fentanyl. Devices used during the procedure included:
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Recurrence of endometrioma was assessed | Recurrence was assessed at 1, 3, and 6 months after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Hoon Shin, MD, PhD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D000091662 | Genital Diseases |