Status:
UNKNOWN
ICG for Visualization of the Ureters in DIE
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Visualization of Ureters in Gynecological Surgery
Deep Infiltrative Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Endometriosis is a common condition with an incidence of approximately 10% of all women in the fertile phase. Deep infiltrating endometriosis (DIE) has been shown to be associated with high morbidity....
Detailed Description
Endometriosis is a common illness with an incidence of about 10% of all premenopausal women. Deep infiltrative endometriosis is associated with high morbidity. The resection of deep infiltrative endom...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature
- Age 18 or older
- Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
- Proven (by laparoscopy or MRI) or highly suspected (ultrasound or clinically) deep infiltrating endometriosis
Exclusion
- No DIE detectable intraoperatively
- Known or suspected allergy to iodine, shellfish, or ICG dye
- Hyperthyroid metabolic state (excluding treated hyperthyroidism with euthyroid metabolic state)
- Severe renal insufficiency (GFR \< 30ml/min)
- Simultaneous therapy with beta-blockers
- Pregnant (positive human chorionic gonadotropin in the blood) or breastfeeding women
- Intention to become pregnant during the course of the study
- Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia)
- Previous history of radiation therapy of the pelvis
- Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery
- Active, non treated urinary tract infection
- Active pyelonephritis
- Women having undergone surgery for reimplantation of the ureters (UCNS) or nephrostomy
Key Trial Info
Start Date :
June 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05206279
Start Date
June 26 2023
End Date
December 1 2025
Last Update
December 7 2023
Active Locations (1)
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1
Inselspital
Bern, Switzerland