A Side-Randomized, Self-Controlled Trial Assessing the Efficacy of Indocyanine Green Fluorescence Imaging for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis

Clinic schedules will be screened for possible surgical candidates by the attending surgeons, fellow, and research assistant. Patients will be recruited from the minimally invasive gynecologic surgery clinics of Dr. Guan. Patients who are meet the inclusion and exclusion criteria will undergo recruitment and be offered to participate in the research study. The research study will be introduced by the surgeon (Dr. Guan) during their pre-operative consultation. If the patient is interested in hearing more about the study and possibly participating, then the investigators will interact with the patient in order to explain the study in detail, answer questions, and obtain informed consent. Patients will be able to learn more about the study and provide consent in-person (after their initial surgical consultation is completed but prior to leaving clinic), through remote consent via telephone, or on the day of surgery. This should allow the patient sufficient time to evaluate the risks and benefits of participation and ensure informed consent or informed refusal of participation, minimizing coercion. Participants will be counseled that their consent or refusal to participate will not otherwise alter their routine perioperative care or surgery.

After the patient was prepped and draped, a 17F sheathed cystoscope was threaded with a single 5F open-ended 27 cm stent. Twenty-five mg of ICG was diluted with 10 ml of normal saline and placed on the lur-lock of a single open-ended stent. The cystoscope was primed. Time was started once the labia were parted to find the urethra. The cystoscope was advanced into the bladder, and both ureteral openings were visualized before placement of the singular stent. The side randomized by computer to receive ICG was again visualized, and the stent was advanced retrograde to a depth of 15 cm. Five ml of ICG was then injected into the stent. The stent was allowed to sit in the same ureter for 60 seconds before the stent and cystoscope were removed. Once all instruments were removed from the urethra, time was stopped and recorded.

Once the robot was docked, the camera was positioned to visualize both pelvic sidewalls. At this point, the surgeon remained blinded to the side injected with ICG. Ureter identification was then performed by the both the surgeon and fellows on each side, and the time required to identify each ureter was recorded. After identification, they rated the difficulty of ureteral dissection on each side using a visual analog scale (VAS), where 0 indicated extremely easy and 10 indicated maximal difficulty, based on anatomical complexity and the extent of adhesions.

When the surgeon begins pelvic sidewall endometriosis resection, timing will be initiated to record the duration of each step and the total operative time for each side. The side without ICG injection will be addressed first. The procedures will follow a standardized sequence: lysis of adhesions - ureterolysis -endometriosis resection.

Following the surgery, the surgeon is required to complete the Surgery Task Load Index (SURG-TLX) for each side.