Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

NCT03950206 | Terminated

• 1 other identifier: ICG and endometriosis
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Ureters; Indocyanine green angiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ureteral vascularization

  Intraoperative

Study Arms (1)

Women with endometriosis

OTHER

Women undergoing laparoscopic surgery for endometriosis

Other: Indocyanine green angiography

Interventions

Indocyanine green angiography OTHER

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.

Women with endometriosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Diego Raimondo

Bologna, BO, 40138, Italy

Location

Related Publications (1)

• Raimondo D, Borghese G, Mabrouk M, Arena A, Ambrosio M, Del Forno S, Degli Esposti E, Casadio P, Mattioli G, Mastronardi M, Seracchioli R. Use of Indocyanine Green for Intraoperative Perfusion Assessment in Women with Ureteral Endometriosis: A Preliminary Study. J Minim Invasive Gynecol. 2021 Jan;28(1):42-49. doi: 10.1016/j.jmig.2020.04.004. Epub 2020 Apr 10.

  PMID: 32283326 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 22, 2021

Record last verified: 2019-11

Locations

IT (1)