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Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Primary Purpose

Endometriosis

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Indocyanine green angiography
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endometriosis focused on measuring Endometriosis, Ureters, Indocyanine green angiography

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Diego Raimondo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Women with endometriosis

Arm Description

Women undergoing laparoscopic surgery for endometriosis

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2019
Last Updated
June 17, 2021
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03950206
Brief Title
Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis
Official Title
Intraoperative Assessment of Ureteral Perfusion Using Indocyanine Green Angiography in Women Submitted to Laparoscopic Surgery for Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
PI decided to terminate the trial
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Ureters, Indocyanine green angiography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Women with endometriosis
Arm Type
Other
Arm Description
Women undergoing laparoscopic surgery for endometriosis
Intervention Type
Other
Intervention Name(s)
Indocyanine green angiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
Description
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)
Time Frame
From the surgery time, assessed up to 7 days after surgery
Secondary Outcome Measure Information:
Title
Ureteral vascularization
Description
Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis
Time Frame
Intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Diego Raimondo
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
32283326
Citation
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.
Results Reference
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Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

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