Endometriosis
Conditions
Keywords
Endometriosis, Ureters, Indocyanine green angiography
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.
Interventions
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.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and safety: Clavien-Dindo Classification (from Grade I to V) | From the surgery time, assessed up to 7 days after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ureteral vascularization | Intraoperative | Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis |
Countries
Italy
Outcome results
None listed