The aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neovascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation
Patients were recruited within the clinical routine after indication for laparoscopy under consideration of the inclusion and exclusion criteria. The first abdominal and pelvi's inspection was made using direct laparoscope visualization under white light conditions. All areas suspected of peritoneal endometriosis were classified as white, black and red lesions and recorded together with their anatomic location in the surgical record for the purposes of subsequent extirpation. After the first visual inspection the patient was administered with 0.05 - 0.25 mg /(kg BW) Indocyanine Green intravenously. The Indocyanine Green imaging mode of the Olympus Indocyanine Green Imaging System was activated and suspected areas in Indocyanine Green imaging mode were recorded with their corresponding appearance in white light mode. If suspected areas were visible either in white light or Indocyanine Green imaging mode, specific sample has been taken from these areas. In addition control biopsy specimens from inconspicuous peritoneum has been taken.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
27
0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously
Catholic University of Sacred Heart
Rome, Italy
Detection of endometriotic lesions
Optical qualitative assessment through the visual evaluation of a single expert surgeon (presence / absence of fluorescence, due to the injection of the Indocyanine Green and the use of the Near Infrared vision, at the level the of suspected endometriotic lesions)
Time frame: Intraoperative
Localization of occult endometriotic lesion
To detect occult endometriotic lesions, thanks to the fluorescence of the Indocyanine Green, that would remain otherwise not visible to the surgeon eye
Time frame: Intraoperative
Operatory Time
To assess if the use of Indocyanine Green cause a significant increase of the operatory time
Time frame: Intraoperative
Complications
To assess if the use of Indocyanine Green increase the percentage of intra and post-operative complications
Time frame: From operatory room up to 3 days
Side effects
Evaluation of possible side effects related to the use of Indocyanine Green as a fluorescent endometriosis' marker
Time frame: From operatory room up to 3 days
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