A Randomized Clinical Trial Evaluating Indigo Carmine as a Visualization Aid for Evaluating Ureteral Patency

Area of Science:

• Urology
• Surgical Visualization
• Medical Imaging

Background:

• Assessing ureteral patency is crucial during urological and gynecological surgeries.
• Current methods for evaluating ureteral patency may have limitations in visualization.
• Indigo carmine is a dye used in medical procedures, but its efficacy for ureteral patency assessment requires further study.

Purpose of the Study:

• To compare the visualization advantage of intravenous indigo carmine against saline for evaluating ureteral patency.
• To assess the safety and efficacy of different indigo carmine doses (2.5 mL and 5.0 mL) in enhancing ureteral visualization.
• To determine if indigo carmine offers a significant improvement over saline in a randomized, controlled clinical trial.

Main Methods:

• A randomized, controlled clinical trial involving patients undergoing urological or gynecological procedures.
• Patients received saline injection, with randomization to either 2.5 mL or 5.0 mL of indigo carmine.
• Blinded video assessments by independent reviewers using a conspicuity scale (1-5); responders defined as scores ≥3 with a +1-point difference from saline.

Main Results:

• Both 2.5 mL and 5.0 mL doses of indigo carmine demonstrated significantly superior visualization compared to saline (P < .0001).
• Most ureters scored 4 or higher on the conspicuity scale with indigo carmine.
• 92.3% of patients were classified as responders, indicating improved visualization with indigo carmine; no adverse events were reported.

Conclusions:

• Intravenous indigo carmine, in both tested doses, serves as a significantly better visualization aid for ureteral patency than saline.
• Indigo carmine is a safe and effective option for enhancing the assessment of ureteral patency during surgical procedures.
• The study supports the routine use of indigo carmine to improve surgical outcomes related to ureteral integrity.