Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Terminated

CT.gov ID

NCT03950206

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Other: Indocyanine green angiography	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Women with endometriosis Women undergoing laparoscopic surgery for endometriosis	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.

Arm

Intervention/Treatment

Other: Women with endometriosis

Women undergoing laparoscopic surgery for endometriosis

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.

Outcome Measures

Primary Outcome Measures

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

Ureteral vascularization [Intraoperative]
Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diego Raimondo	Bologna	BO	Italy	40138

Sponsors and Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renato Seracchioli, Principal Investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna

ClinicalTrials.gov Identifier:

NCT03950206

Other Study ID Numbers:

ICG and endometriosis

First Posted:

May 15, 2019

Last Update Posted:

Jun 22, 2021

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Renato Seracchioli, Principal Investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Endometriosis

Ureters

Indocyanine green angiography

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Jun 22, 2021