Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Terminated

Conditions: Endometriosis

Treatments: Other: Indocyanine green angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT03950206

ICG and endometriosis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing laparoscopic surgery for endometriosis
• informed consent to participate in the study

Exclusion criteria

• known or suspected allergy to iodide
• history of active pelvic infection
• presence of intra-abdominal or pelvic malignancy
• pelvic radiation therapy
• hyperthyroidism
• liver dysfunction
• serum creatinine > 2.0 mg/dL

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Women with endometriosis

Other group

Description:

Women undergoing laparoscopic surgery for endometriosis

Treatment:

Other: Indocyanine green angiography