Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03950206
• Other study ID #: ICG and endometriosis
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2019
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Italy	Diego Raimondo	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ureteral vascularization	Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis	Intraoperative