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

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

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18+

SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage III or IV endometriosis (rASRM classification)

Planned robotic transabdominal endometriosis excision with or without hysterectomy.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

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/Surgery
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Arm A: ICG-Assisted Ureteral Identification (Unilateral)Experimental treatment 1 intervention

Group B: Arm B: Standard Visualization (Contralateral Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Comparison of operative time between the ICG-assisted and standard visualization sides

Total operative time was calculated for each side, as well as for each individual procedure. The total operative time represents the sum of the operative times for all individual procedures performed.

Time frame

Intraoperative, measured during the surgical procedure on the day of surgery.

Secondary outcomes

Incidence of ureter or bladder symptoms or complications & Surgical complication rate by Clavien-Dindo classification

Number and percentage of participants with postoperative ureter or bladder-related symptoms or complications, confirmed by clinical evaluation.Number and percentage of participants experiencing surgical complications, graded according to the Clavien-Dindo classification system.

Time frame

Postoperative, up to 6 weeks after surgery.

Sponsors and contacts

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Baylor College of Medicine

Lead sponsor

Source ClinicalTrials.gov

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