Assessing the Efficacy of Indocyanine Green for Ureter Identification During Robot-Assisted Surgery in Advanced-Stage Endometriosis

Conditions

• Deep Infiltrating Endometriosis (DIE)
• Endometriosis (Diagnosis)
• Endometriosis Ovaries
• Endometriosis Pelvic
• Endometriosis of the Cul-de-sac
• Indocyanine Green (ICG)
• Robotic Surgical Procedure
• Ureteral Injury
• Ureteral Stent Placement

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Indocyanine Green (ICG)-Assisted Ureteral Identification — DRUG
  A temporary ureteral stent will be placed unilaterally (left or right) prior to robotic procedures in participants undergoing robot-assisted single-site surgery for advanced-stage endometriosis. Indocyanine green (ICG) will be administered through the stent to enable real-time fluorescence imaging for intraoperative ureter identification. The contralateral ureter will be identified using standard visualization techniques without ICG. Side allocation (ICG vs. control) will be determined by computer-generated block randomization.
• Standard Ureteral Identification without ICG — PROCEDURE
  Ureter identification will be performed using standard intraoperative visualization techniques without the use of indocyanine green (ICG) fluorescence imaging. This will be done on the contralateral side to the randomized ICG-assisted ureteral identification during robot-assisted single-site surgery for advanced-stage endometriosis.

Study Details

The goal of this side-randomized, self-controlled trial, 1-site study is to explore the efficacy of Indocyanine Green Fluorescence (ICG) for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis. Researchers will perform temporary ureteral stent using indocyanine green fluorescence for intraoperative ureteral identification on either the left or right side of subjects who are undergoing a robotic assisted transumbilical resection of advanced endometriosis. Participants will be randomized to receive ICG-assisted ureteral identification on either the left or right side. Randomization will be conducted using a computer-generated block randomization method. The primary aim is to determine whether ICG-assisted ureter visualization can reduce operative time for endometriosis resection and ureterolysis, and minimize the risk of ureteral injury. Secondary objectives are to assess the feasibility and safety of temporary ureteral ICG stenting for intraoperative ureter identification in advanced endometriosis.

Key Dates

Start date

Oct 1, 2025

Status verified

Aug 2025

Primary completion

Feb 1, 2026

Completion

Mar 15, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: ICG-Assisted Ureteral Identification (Unilateral)
  Participants assigned to this study will undergo intraoperative ureteral identification using indocyanine green (ICG) fluorescence imaging in either left or right side. A temporary ureteral stent will be inserted on the randomized side (left or right) prior to ureterolysis and endometriosis resection. ICG will be administered through the stent to facilitate real-time fluorescence visualization of the ureter during robot-assisted single-site surgery. The contralateral side will serve as the control arm (standard visualization without ICG).
• Active Comparator: Arm B: Standard Visualization (Contralateral Control)
  Participants assigned to this study will undergo intraoperative ureteral identification using indocyanine green (ICG) fluorescence imaging in either left or right side. A temporary ureteral stent will be inserted on the randomized side (left or right) prior to ureterolysis and endometriosis resection. ICG will be administered through the stent to facilitate real-time fluorescence visualization of the ureter during robot-assisted single-site surgery. The contralateral side will serve as the control arm (standard visualization without ICG).

Primary Outcome Measure

Comparison of operative time between the ICG-assisted and standard visualization sides [ Time Frame: Intraoperative, measured during the surgical procedure on the day of surgery. ]

Central Contacts

• Ann Tims
  8328267464
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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