Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: Indocyanine green angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Women with endometriosis<br>Women undergoing laparoscopic surgery for endometriosis | Other: Indocyanine green angiography<br>* 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&amp; Co., Tuttlingen, Germany) will be used to visualize the ureteral vascularization.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ureteral vascularization | Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Ureters, Indocyanine green angiography