ICG for Visualization of the Ureters in DIE
NCT05206279
· ctgov
completed
- Enrollment
- 51
- Start
- 2023-06-26
- Completion
- 2024-09-01
- Last updated
- 2026-06-17
- Has results
- False
- Countries
- Switzerland
Conditions
Tagged with
Interventions
-
Ureteral injection of Indocyanine Green Powder (diluted)
DRUG
The intervention we study is the intraureteral injection of ICG during a laparoscopic deep infiltrative endometriosis resection procedure. Cystoscopy with intraureteral administration of ICG will be performed, after which intervention the ureters will be examined by laparoscopy. ICG is injected cystoscopy-guided into the ureters (cystoscopy-guided) in a dosage of 5 or 10ml (25mg ICG in 5 or 10ml NaCl) per ureter as a bolus injection.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine