Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Not Applicable

Terminated

• Conditions: Endometriosis
• Interventions: Other: Indocyanine green angiography

• Registration Number: NCT03950206
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2019-06-01
• Status Verified: 2019-11
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with endometriosis	Indocyanine green angiography	Women undergoing laparoscopic surgery for endometriosis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Ureteral vascularization	Intraoperative	Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis

Trial Locations

Locations (1)

Diego Raimondo; 🇮🇹 Bologna, BO, Italy