Ureteric Identification Using Indocyanine Green Dye Versus Conventional Ureteric Stenting to Reduce Post-operative Pain and Surgical Morbidity During Endometriosis Surgery

Launched by UNIVERSITY HOSPITALS OF NORTH MIDLANDS NHS TRUST · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new method to help women with deep endometriosis who may need surgery. Endometriosis is a condition where tissue similar to the lining of the womb grows in other areas, causing pain and sometimes infertility. During surgery, doctors usually place small plastic tubes called stents in the ureters (the tubes that carry urine from the kidneys to the bladder) to prevent damage. However, these stents can cause severe pain and other issues after surgery. The trial is exploring whether using a special dye instead of stents can help reduce post-operative pain and complications, making recovery easier for women.

To participate in this study, women aged 18 to 50 who are scheduled for surgery to remove deep endometriosis and need ureteric stenting may be eligible. Participants will need to agree to take part in the study and must be in good health without certain medical conditions, like severe heart problems or high BMI. The trial is not yet recruiting participants, but once it begins, women involved can expect to help researchers understand if the dye method is a safer and less painful option compared to traditional stenting.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged 18 to 50 years
• • Scheduled for laparoscopic or robotic-assisted surgical excision of deep endometriosis (DE) where ureteric stenting is planned.
• • Willing and able to provide consent for participation in the study
• Exclusion Criteria:
• • Confirmed or suspected pregnancy at the time of enrolment.
• • Suspicion or confirmation of malignancy.
• • History of ureteric injury from prior surgery or trauma
• * Medically unfit for surgery due to the following conditions:
• • Uncontrolled diabetes mellitus.
• • Severe Chronic Obstructive Pulmonary Disease (COPD).
• • Hypertrophic cardiomyopathy or significant cardiac conditions (e.g., recent myocardial infarction, aortic stenosis).
• • History of stroke or severe kyphoscoliosis.
• • Uncontrolled hypertension.
• • Body mass index (BMI): BMI greater than 45