NCT03950206

Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Intraoperative Assessment of Ureteral Perfusion Using Indocyanine Green Angiography in Women Submitted to Laparoscopic Surgery for Endometriosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
OTHER	Indocyanine green angiography	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.

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-05-15
• Last updated: 2021-06-22

Locations

1 site across 1 country: Italy