Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Location status: Recruiting
NCT Number: NCT07813247
This is a prospective randomized study comparing robotic adrenalectomy with versus without intraoperative indocyanine green imaging.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Identification of the adrenal gland intraoperatively is critical to get in to the correct surgical plane and perform minimally invasive adrenalectomy with clear margins and without causing excessive bleeding. Intraoperative ultrasound has been used traditionally, but suffers from air artefact when there is insufficient contact between the tissue and the ultrasound probe. Furthermore, intraoperative ultrasound requires interruption of the procedure for the ultrasound, prolonging operative time and may not be possible when the dissection plane deepens. Indocyanine green (ICG) fluorescence has emerged over the past few years as a new intraoperative imaging modality. As ICG fluorescence is directly related to the perfusion of tissues and the adrenal gland has one of the highest blood supplies among organs in the abdomen, the adrenalectomy is a perfect application of this technology. Our group, as well as others, have described the safety and feasibility of ICG fluorescence imaging during robotic adrenalectomy over the last decade, however, whether the use of this imaging creates an impact of robotic adrenalectomy on intraoperative and perioperative outcomes is unknown, as no randomized study has been done on this topic.
It is unknown if intraoperative ICG imaging improves outcomes compared to conventional adrenalectomy that does not use this imaging. Based on our retrospective experience, ICG-guided adrenalectomy may facilitate dissection part of the procedure and hence shorten operative time by providing a road map regarding the dissection planes in different steps of the operation. So, the hypothesis of the study is that ICG imaging may shorten the dissection step of minimally invasive adrenalectomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intraoperative use of indocyanine green imaging during robotic adrenalectomy
Time frame: intraoperative
duration of time for adrenal dissection in robotic adrenalectomy
The Cleveland Clinic
Other
Randomized Prospective Study of Robotic Adrenalectomy With Versus Without Indocyanine Green Fluorescence Imaging
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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