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PI decided to terminate the trial
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Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters.
Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.
Ureter perfusion will be intraoperatively assessed using indocyanine green angiography.
After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with endometriosis | Other | Women undergoing laparoscopic surgery for endometriosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green angiography | Other | Intravenous ICG (PULSION Medical Systems SE, Feldkirchen, Germany) will be used for the intraoperative evaluation of ureteral vascularization. Twenty-five milligrams of indocyanine green will be diluted in 10 ml of soluble water, and a bolus of 0.25 mg/Kg will be injected through a peripheral vein. During laparoscopy, a NIR camera-head (KARL STORZ Gesellschaft Mit Beschränkter Haftung& Co., Tuttlingen, Germany) will be used to visualize the ureteral vascularization. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and safety: Clavien-Dindo Classification (from Grade I to V) | Evaluation of feasibility and safety of indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis, considering complications using Clavien-Dindo Classification (from Grade I to V) | From the surgery time, assessed up to 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ureteral vascularization | Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diego Raimondo | Bologna | BO | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32283326 | Derived | Raimondo D, Borghese G, Mabrouk M, Arena A, Ambrosio M, Del Forno S, Degli Esposti E, Casadio P, Mattioli G, Mastronardi M, Seracchioli R. Use of Indocyanine Green for Intraoperative Perfusion Assessment in Women with Ureteral Endometriosis: A Preliminary Study. J Minim Invasive Gynecol. 2021 Jan;28(1):42-49. doi: 10.1016/j.jmig.2020.04.004. Epub 2020 Apr 10. |
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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 |